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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT01855997
Registration number
NCT01855997
Ethics application status
Date submitted
8/05/2013
Date registered
17/05/2013
Date last updated
5/04/2017
Titles & IDs
Public title
A Study to Collect Blood Biomarker Samples From Participants With Chronic Hepatitis B (CHB) Who Received Treatment With Pegasys (Peginterferon Alfa-2a) ± Nucleoside/Nucleotide Analogue
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Scientific title
A Phase IV, Blood Sample Collection Study For Exploratory Evaluation of the Association of Single Nucleotide Polymorphisms With Treatment Responses From Subjects With HBe-Antigen Positive or Negative Chronic Hepatitis B, Who Received Therapy for Hepatitis B With Peginterferon Alfa-2a 40kD (Peg-IFN) ± Nucleos(t)Ide Analogue
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Secondary ID [1]
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GV28855
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Hepatitis B, Chronic
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0
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Condition category
Condition code
Infection
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0
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Other infectious diseases
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Oral and Gastrointestinal
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0
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0
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Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
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Intervention/exposure
Study type
Observational
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Patient registry
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Target follow-up duration
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Target follow-up type
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Description of intervention(s) / exposure
Treatment: Drugs - Peg-IFN alfa-2a
Adult CHB Participants Treated With Peg-IFN Alfa-2a - Adult participants with CHB infection, and who have completed at least 24 weeks of Peg-IFN alfa-2a with/without nucleoside analogue therapy and at least 24 weeks of follow-up, will be included. Participants will be recruited from Roche clinical trials or general practice; no treatment will be administered in this non-interventional study.
Treatment: Drugs: Peg-IFN alfa-2a
Participants received Peg-IFN alfa-2a prior to enrollment for at least 24 weeks. Dosing was chosen according to standard of care or at the discretion of the treating physician.
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Single Nucleotide Polymorphisms (SNPs) Associated With HBeAg Seroconversion or Hepatitis B Surface Antigen (HBsAg) Clearance =24 Weeks Post-Treatment in HBeAg-Positive East Asian (CN) Population: Additive Model
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Assessment method [1]
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0
Genome-wide association study (GWAS) approach was used to evaluate the association of SNPs with treatment response. HBeAg seroconversion was defined as the loss of HBeAg and detection of the antibody to HBeAg (anti-HBe). HBsAg clearance was defined as the loss of HBsAg, with or without detection of the antibody to HBsAg (anti-HBs). Associations with treatment response were analyzed using logistic regression and adjusted for covariates. Markers were coded according to additive models of inheritance. Markers surpassing p-value thresholds of p\<10\^-5 and p\<5x10\^-8 were considered suggestive and genome-wide significant, respectively. Larger beta coefficients correspond to greater likelihood of treatment response.
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Timepoint [1]
0
0
Single blood sample =24 weeks post-treatment
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Primary outcome [2]
0
0
SNPs Associated With HBeAg Seroconversion or HBsAg Clearance =24 Weeks Post-Treatment in HBeAg-Positive CN Population: Dominant Model
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Assessment method [2]
0
0
GWAS approach was used to evaluate the association of SNPs with treatment response. HBeAg seroconversion was defined as the loss of HBeAg and detection of anti-HBe. HBsAg clearance was defined as the loss of HBsAg, with or without detection of anti-HBs. Associations with treatment response were analyzed using logistic regression and adjusted for covariates. Markers were coded according to dominant models of inheritance. Markers surpassing p-value thresholds of p\<10\^-5 and p\<5x10\^-8 were considered suggestive and genome-wide significant, respectively. Larger beta coefficients correspond to greater likelihood of treatment response.
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Timepoint [2]
0
0
Single blood sample =24 weeks post-treatment
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Primary outcome [3]
0
0
SNPs Associated With HBeAg Seroconversion or HBsAg Clearance =24 Weeks Post-Treatment in HBeAg-Positive Population: Additive Model
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Assessment method [3]
0
0
GWAS approach was used to evaluate the association of SNPs with treatment response. HBeAg seroconversion was defined as the loss of HBeAg and detection of anti-HBe. HBsAg clearance was defined as the loss of HBsAg, with or without detection of anti-HBs. Associations with treatment response were analyzed using logistic regression and adjusted for covariates. Markers were coded according to additive models of inheritance. Markers surpassing p-value thresholds of p\<10\^-5 and p\<5x10\^-8 were considered suggestive and genome-wide significant, respectively. Larger beta coefficients correspond to greater likelihood of treatment response.
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Timepoint [3]
0
0
Single blood sample =24 weeks post-treatment
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Primary outcome [4]
0
0
SNPs Associated With HBeAg Seroconversion or HBsAg Clearance =24 Weeks Post-Treatment in HBeAg-Positive Population: Dominant Model
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Assessment method [4]
0
0
GWAS approach was used to evaluate the association of SNPs with treatment response. HBeAg seroconversion was defined as the loss of HBeAg and detection of anti-HBe. HBsAg clearance was defined as the loss of HBsAg, with or without detection of anti-HBs. Associations with treatment response were analyzed using logistic regression and adjusted for covariates. Markers were coded according to dominant models of inheritance. Markers surpassing p-value thresholds of p\<10\^-5 and p\<5x10\^-8 were considered suggestive and genome-wide significant, respectively. Larger beta coefficients correspond to greater likelihood of treatment response.
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Timepoint [4]
0
0
Single blood sample =24 weeks post-treatment
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Primary outcome [5]
0
0
SNPs Associated With HBeAg Seroconversion Plus Undetectable Hepatitis B Virus (HBV) Deoxyribonucleic Acid (DNA) or HBsAg Clearance =24 Weeks Post-Treatment in HBeAg-Positive CN Population: Additive Model
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Assessment method [5]
0
0
GWAS approach was used to evaluate association of SNPs with treatment response. HBeAg seroconversion was defined as the loss of HBeAg and detection of anti-HBe. Undetectable HBV DNA was defined as HBV DNA level below the lower limit of detection (LLD) of 2000 international units per milliliter (IU/mL). HBsAg clearance was defined as the loss of HBsAg, with or without detection of anti-HBs. HBeAg seroconversion and undetectable HBV DNA were a combined criterion in treatment response. Associations with treatment response were analyzed using logistic regression and adjusted for covariates. Markers were coded according to additive models of inheritance. Markers surpassing p-value thresholds of p\<10\^-5 and p\<5x10\^-8 were considered suggestive and genome-wide significant, respectively. Larger beta coefficients correspond to greater likelihood of treatment response.
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Timepoint [5]
0
0
Single blood sample =24 weeks post-treatment
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Primary outcome [6]
0
0
SNPs Associated With HBeAg Seroconversion Plus Undetectable HBV DNA or HBsAg Clearance =24 Weeks Post-Treatment in HBeAg-Positive CN Population: Dominant Model
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Assessment method [6]
0
0
GWAS approach was used to evaluate the association of SNPs with treatment response. HBeAg seroconversion was defined as the loss of HBeAg and detection of anti-HBe. Undetectable HBV DNA was defined as an HBV DNA level below the LLD of 2000 IU/mL. HBsAg clearance was defined as the loss of HBsAg, with or without detection of anti-HBs. HBeAg seroconversion and undetectable HBV DNA were a combined criterion in treatment response. Associations with treatment response were analyzed using logistic regression and adjusted for covariates. Markers were coded according to dominant models of inheritance. Markers surpassing p-value thresholds of p\<10\^-5 and p\<5x10\^-8 were considered suggestive and genome-wide significant, respectively. Larger beta coefficients correspond to greater likelihood of treatment response.
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Timepoint [6]
0
0
Single blood sample =24 weeks post-treatment
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Primary outcome [7]
0
0
SNPs Associated With HBeAg Seroconversion Plus Undetectable HBV DNA or HBsAg Clearance =24 Weeks Post-Treatment in HBeAg-Positive Population: Additive Model
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Assessment method [7]
0
0
GWAS approach was used to evaluate the association of SNPs with treatment response. HBeAg seroconversion was defined as the loss of HBeAg and detection of anti-HBe. Undetectable HBV DNA was defined as an HBV DNA level below the LLD of 2000 IU/mL. HBsAg clearance was defined as the loss of HBsAg, with or without detection of anti-HBs. HBeAg seroconversion and undetectable HBV DNA were a combined criterion in treatment response. Associations with treatment response were analyzed using logistic regression and adjusted for covariates. Markers were coded according to additive models of inheritance. Markers surpassing p-value thresholds of p\<10\^-5 and p\<5x10\^-8 were considered suggestive and genome-wide significant, respectively. Larger beta coefficients correspond to greater likelihood of treatment response.
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Timepoint [7]
0
0
Single blood sample =24 weeks post-treatment
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Primary outcome [8]
0
0
SNPs Associated With HBeAg Seroconversion Plus Undetectable HBV DNA or HBsAg Clearance =24 Weeks Post-Treatment in HBeAg-Positive Population: Dominant Model
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Assessment method [8]
0
0
GWAS approach was used to evaluate the association of SNPs with treatment response. HBeAg seroconversion was defined as the loss of HBeAg and detection of anti-HBe. Undetectable HBV DNA was defined as an HBV DNA level below the LLD of 2000 IU/mL. HBsAg clearance was defined as the loss of HBsAg, with or without detection of anti-HBs. HBeAg seroconversion and undetectable HBV DNA were a combined criterion in treatment response. Associations with treatment response were analyzed using logistic regression and adjusted for covariates. Markers were coded according to dominant models of inheritance. Markers surpassing p-value thresholds of p\<10\^-5 and p\<5x10\^-8 were considered suggestive and genome-wide significant, respectively. Larger beta coefficients correspond to greater likelihood of treatment response.
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Timepoint [8]
0
0
Single blood sample =24 weeks post-treatment
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Primary outcome [9]
0
0
SNPs Associated With Undetectable HBV DNA or HBsAg Clearance =24 Weeks Post-Treatment in HBeAg-Negative Non-East Asian (Non-CN) Population: Additive Model
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Assessment method [9]
0
0
GWAS approach was used to evaluate the association of SNPs with treatment response. Undetectable HBV DNA was defined as an HBV DNA level below the LLD of 2000 IU/mL. HBsAg clearance was defined as the loss of HBsAg, with or without detection of anti-HBs. Associations with treatment response were analyzed using logistic regression and adjusted for covariates. Markers were coded according to additive models of inheritance. Markers surpassing p-value thresholds of p\<10\^-5 and p\<5x10\^-8 were considered suggestive and genome-wide significant, respectively. Larger beta coefficients correspond to greater likelihood of treatment response. Only a single SNP (rs17037122) was included in the analysis.
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Timepoint [9]
0
0
Single blood sample =24 weeks post-treatment
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Primary outcome [10]
0
0
SNPs Associated With Undetectable HBV DNA or HBsAg Clearance =24 Weeks Post-Treatment in HBeAg-Negative Non-CN Population: Dominant Model
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Assessment method [10]
0
0
GWAS approach was used to evaluate the association of SNPs with treatment response. Undetectable HBV DNA was defined as an HBV DNA level below the LLD of 2000 IU/mL. HBsAg clearance was defined as the loss of HBsAg, with or without detection of anti-HBs. Associations with treatment response were analyzed using logistic regression and adjusted for covariates. Markers were coded according to dominant models of inheritance. Markers surpassing p-value thresholds of p\<10\^-5 and p\<5x10\^-8 were considered suggestive and genome-wide significant, respectively. Larger beta coefficients correspond to greater likelihood of treatment response. Only a single SNP (rs17037122) was included in the analysis.
Query!
Timepoint [10]
0
0
Single blood sample =24 weeks post-treatment
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Primary outcome [11]
0
0
SNPs Associated With Undetectable HBV DNA or HBsAg Clearance =24 Weeks Post-Treatment in HBeAg-Negative CN Population: Additive Model
Query!
Assessment method [11]
0
0
GWAS approach was used to evaluate the association of SNPs with treatment response. Undetectable HBV DNA was defined as an HBV DNA level below the LLD of 2000 IU/mL. HBsAg clearance was defined as the loss of HBsAg, with or without detection of anti-HBs. Associations with treatment response were analyzed using logistic regression and adjusted for covariates. Markers were coded according to additive models of inheritance. Markers surpassing p-value thresholds of p\<10\^-5 and p\<5x10\^-8 were considered suggestive and genome-wide significant, respectively. Larger beta coefficients correspond to greater likelihood of treatment response. Only a single SNP (rs2464266) was included in the analysis.
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Timepoint [11]
0
0
Single blood sample =24 weeks post-treatment
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Primary outcome [12]
0
0
SNPs Associated With Undetectable HBV DNA or HBsAg Clearance =24 Weeks Post-Treatment in HBeAg-Negative CN Population: Dominant Model
Query!
Assessment method [12]
0
0
GWAS approach was used to evaluate the association of SNPs with treatment response. Undetectable HBV DNA was defined as an HBV DNA level below the LLD of 2000 IU/mL. HBsAg clearance was defined as the loss of HBsAg, with or without detection of anti-HBs. Associations with treatment response were analyzed using logistic regression and adjusted for covariates. Markers were coded according to dominant models of inheritance. Markers surpassing p-value thresholds of p\<10\^-5 and p\<5x10\^-8 were considered suggestive and genome-wide significant, respectively. Larger beta coefficients correspond to greater likelihood of treatment response.
Query!
Timepoint [12]
0
0
Single blood sample =24 weeks post-treatment
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Primary outcome [13]
0
0
SNPs Associated With Undetectable HBV DNA or HBsAg Clearance =24 Weeks Post-Treatment in HBeAg-Negative Population: Additive Model
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Assessment method [13]
0
0
GWAS approach was used to evaluate the association of SNPs with treatment response. Undetectable HBV DNA was defined as an HBV DNA level below the LLD of 2000 IU/mL. HBsAg clearance was defined as the loss of HBsAg, with or without detection of anti-HBs. Associations with treatment response were analyzed using logistic regression and adjusted for covariates. Markers were coded according to additive models of inheritance. Markers surpassing p-value thresholds of p\<10\^-5 and p\<5x10\^-8 were considered suggestive and genome-wide significant, respectively. Larger beta coefficients correspond to greater likelihood of treatment response.
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Timepoint [13]
0
0
Single blood sample =24 weeks post-treatment
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Primary outcome [14]
0
0
SNPs Associated With Undetectable HBV DNA or HBsAg Clearance =24 Weeks Post-Treatment in HBeAg-Negative Population: Dominant Model
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Assessment method [14]
0
0
GWAS approach was used to evaluate the association of SNPs with treatment response. Undetectable HBV DNA was defined as an HBV DNA level below the LLD of 2000 IU/mL. HBsAg clearance was defined as the loss of HBsAg, with or without detection of anti-HBs. Associations with treatment response were analyzed using logistic regression and adjusted for covariates. Markers were coded according to dominant models of inheritance. Markers surpassing p-value thresholds of p\<10\^-5 and p\<5x10\^-8 were considered suggestive and genome-wide significant, respectively. Larger beta coefficients correspond to greater likelihood of treatment response.
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Timepoint [14]
0
0
Single blood sample =24 weeks post-treatment
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Primary outcome [15]
0
0
SNPs Associated With HBeAg Seroconversion, HBsAg Clearance, or Undetectable HBV DNA =24 Weeks Post-Treatment in Non-CN Population: Additive Model
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Assessment method [15]
0
0
GWAS approach was used to evaluate the association of SNPs with treatment response. HBeAg seroconversion was defined as the loss of HBeAg and detection of anti-HBe. HBsAg clearance was defined as the loss of HBsAg, with or without detection of anti-HBs. Undetectable HBV DNA was defined as an HBV DNA level below the LLD of 2000 IU/mL. Associations with treatment response were analyzed using logistic regression and adjusted for covariates. Markers were coded according to additive models of inheritance. Markers surpassing p-value thresholds of p\<10\^-5 and p\<5x10\^-8 were considered suggestive and genome-wide significant, respectively. Larger beta coefficients correspond to greater likelihood of treatment response.
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Timepoint [15]
0
0
Single blood sample =24 weeks post-treatment
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Primary outcome [16]
0
0
SNPs Associated With HBeAg Seroconversion, HBsAg Clearance, or Undetectable HBV DNA =24 Weeks Post-Treatment in Non-CN Population: Dominant Model
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Assessment method [16]
0
0
GWAS approach was used to evaluate the association of SNPs with treatment response. HBeAg seroconversion was defined as the loss of HBeAg and detection of anti-HBe. HBsAg clearance was defined as the loss of HBsAg, with or without detection of anti-HBs. Undetectable HBV DNA was defined as an HBV DNA level below the LLD of 2000 IU/mL. Associations with treatment response were analyzed using logistic regression and adjusted for covariates. Markers were coded according to dominant models of inheritance. Markers surpassing p-value thresholds of p\<10\^-5 and p\<5x10\^-8 were considered suggestive and genome-wide significant, respectively. Larger beta coefficients correspond to greater likelihood of treatment response. Only a single SNP (rs17037122) was included in the analysis.
Query!
Timepoint [16]
0
0
Single blood sample =24 weeks post-treatment
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Primary outcome [17]
0
0
SNPs Associated With HBeAg Seroconversion, HBsAg Clearance, or Undetectable HBV DNA =24 Weeks Post-Treatment in CN Population: Additive Model
Query!
Assessment method [17]
0
0
GWAS approach was used to evaluate the association of SNPs with treatment response. HBeAg seroconversion was defined as the loss of HBeAg and detection of anti-HBe. HBsAg clearance was defined as the loss of HBsAg, with or without detection of anti-HBs. Undetectable HBV DNA was defined as an HBV DNA level below the LLD of 2000 IU/mL. Associations with treatment response were analyzed using logistic regression and adjusted for covariates. Markers were coded according to additive models of inheritance. Markers surpassing p-value thresholds of p\<10\^-5 and p\<5x10\^-8 were considered suggestive and genome-wide significant, respectively. Larger beta coefficients correspond to greater likelihood of treatment response.
Query!
Timepoint [17]
0
0
Single blood sample =24 weeks post-treatment
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Primary outcome [18]
0
0
SNPs Associated With HBeAg Seroconversion, HBsAg Clearance, or Undetectable HBV DNA =24 Weeks Post-Treatment in CN Population: Dominant Model
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Assessment method [18]
0
0
GWAS approach was used to evaluate the association of SNPs with treatment response. HBeAg seroconversion was defined as the loss of HBeAg and detection of anti-HBe. HBsAg clearance was defined as the loss of HBsAg, with or without detection of anti-HBs. Undetectable HBV DNA was defined as an HBV DNA level below the LLD of 2000 IU/mL. Associations with treatment response were analyzed using logistic regression and adjusted for covariates. Markers were coded according to dominant models of inheritance. Markers surpassing p-value thresholds of p\<10\^-5 and p\<5x10\^-8 were considered suggestive and genome-wide significant, respectively. Larger beta coefficients correspond to greater likelihood of treatment response.
Query!
Timepoint [18]
0
0
Single blood sample =24 weeks post-treatment
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Primary outcome [19]
0
0
SNPs Associated With HBeAg Seroconversion, HBsAg Clearance, or Undetectable HBV DNA =24 Weeks Post-Treatment: Additive Model
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Assessment method [19]
0
0
GWAS approach was used to evaluate the association of SNPs with treatment response. HBeAg seroconversion was defined as the loss of HBeAg and detection of anti-HBe. HBsAg clearance was defined as the loss of HBsAg, with or without detection of anti-HBs. Undetectable HBV DNA was defined as an HBV DNA level below the LLD of 2000 IU/mL. Associations with treatment response were analyzed using logistic regression and adjusted for covariates. Markers were coded according to additive models of inheritance. Markers surpassing p-value thresholds of p\<10\^-5 and p\<5x10\^-8 were considered suggestive and genome-wide significant, respectively. Larger beta coefficients correspond to greater likelihood of treatment response.
Query!
Timepoint [19]
0
0
Single blood sample =24 weeks post-treatment
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Primary outcome [20]
0
0
SNPs Associated With HBeAg Seroconversion, HBsAg Clearance, or Undetectable HBV DNA =24 Weeks Post-Treatment: Dominant Model
Query!
Assessment method [20]
0
0
GWAS approach was used to evaluate the association of SNPs with treatment response. HBeAg seroconversion was defined as the loss of HBeAg and detection of anti-HBe. HBsAg clearance was defined as the loss of HBsAg, with or without detection of anti-HBs. Undetectable HBV DNA was defined as an HBV DNA level below the LLD of 2000 IU/mL. Associations with treatment response were analyzed using logistic regression and adjusted for covariates. Markers were coded according to dominant models of inheritance. Markers surpassing p-value thresholds of p\<10\^-5 and p\<5x10\^-8 were considered suggestive and genome-wide significant, respectively. Larger beta coefficients correspond to greater likelihood of treatment response.
Query!
Timepoint [20]
0
0
Single blood sample =24 weeks post-treatment
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Primary outcome [21]
0
0
SNPs Associated With HBeAg Seroconversion Plus Undetectable HBV DNA, HBsAg Clearance, or Undetectable HBV DNA =24 Weeks Post-Treatment in Non-CN Population: Additive Model
Query!
Assessment method [21]
0
0
GWAS approach was used to evaluate the association of SNPs with treatment response. HBeAg seroconversion was defined as the loss of HBeAg and detection of anti-HBe. Undetectable HBV DNA was defined as an HBV DNA level below the LLD of 2000 IU/mL. HBsAg clearance was defined as the loss of HBsAg, with or without detection of anti-HBs. HBeAg seroconversion and undetectable HBV DNA were a combined criterion in treatment response. Associations with treatment response were analyzed using logistic regression and adjusted for covariates. Markers were coded according to additive models of inheritance. Markers surpassing p-value thresholds of p\<10\^-5 and p\<5x10\^-8 were considered suggestive and genome-wide significant, respectively. Larger beta coefficients correspond to greater likelihood of treatment response.
Query!
Timepoint [21]
0
0
Single blood sample =24 weeks post-treatment
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Primary outcome [22]
0
0
SNPs Associated With HBeAg Seroconversion Plus Undetectable HBV DNA, HBsAg Clearance, or Undetectable HBV DNA =24 Weeks Post-Treatment in Non-CN Population: Dominant Model
Query!
Assessment method [22]
0
0
GWAS approach was used to evaluate the association of SNPs with treatment response. HBeAg seroconversion was defined as the loss of HBeAg and detection of anti-HBe. Undetectable HBV DNA was defined as an HBV DNA level below the LLD of 2000 IU/mL. HBsAg clearance was defined as the loss of HBsAg, with or without detection of anti-HBs. HBeAg seroconversion and undetectable HBV DNA were a combined criterion in treatment response. Associations with treatment response were analyzed using logistic regression and adjusted for covariates. Markers were coded according to dominant models of inheritance. Markers surpassing p-value thresholds of p\<10\^-5 and p\<5x10\^-8 were considered suggestive and genome-wide significant, respectively. Larger beta coefficients correspond to greater likelihood of treatment response.
Query!
Timepoint [22]
0
0
Single blood sample =24 weeks post-treatment
Query!
Primary outcome [23]
0
0
SNPs Associated With HBeAg Seroconversion Plus Undetectable HBV DNA, HBsAg Clearance, or Undetectable HBV DNA =24 Weeks Post-Treatment in CN Population: Additive Model
Query!
Assessment method [23]
0
0
GWAS approach was used to evaluate the association of SNPs with treatment response. HBeAg seroconversion was defined as the loss of HBeAg and detection of anti-HBe. Undetectable HBV DNA was defined as an HBV DNA level below the LLD of 2000 IU/mL. HBsAg clearance was defined as the loss of HBsAg, with or without detection of anti-HBs. HBeAg seroconversion and undetectable HBV DNA were a combined criterion in treatment response. Associations with treatment response were analyzed using logistic regression and adjusted for covariates. Markers were coded according to additive models of inheritance. Markers surpassing p-value thresholds of p\<10\^-5 and p\<5x10\^-8 were considered suggestive and genome-wide significant, respectively. Larger beta coefficients correspond to greater likelihood of treatment response.
Query!
Timepoint [23]
0
0
Single blood sample =24 weeks post-treatment
Query!
Primary outcome [24]
0
0
SNPs Associated With HBeAg Seroconversion Plus Undetectable HBV DNA, HBsAg Clearance, or Undetectable HBV DNA =24 Weeks Post-Treatment in CN Population: Dominant Model
Query!
Assessment method [24]
0
0
GWAS approach was used to evaluate the association of SNPs with treatment response. HBeAg seroconversion was defined as the loss of HBeAg and detection of anti-HBe. Undetectable HBV DNA was defined as an HBV DNA level below the LLD of 2000 IU/mL. HBsAg clearance was defined as the loss of HBsAg, with or without detection of anti-HBs. HBeAg seroconversion and undetectable HBV DNA were a combined criterion in treatment response. Associations with treatment response were analyzed using logistic regression and adjusted for covariates. Markers were coded according to dominant models of inheritance. Markers surpassing p-value thresholds of p\<10\^-5 and p\<5x10\^-8 were considered suggestive and genome-wide significant, respectively. Larger beta coefficients correspond to greater likelihood of treatment response.
Query!
Timepoint [24]
0
0
Single blood sample =24 weeks post-treatment
Query!
Primary outcome [25]
0
0
SNPs Associated With HBeAg Seroconversion Plus Undetectable HBV DNA, HBsAg Clearance, or Undetectable HBV DNA =24 Weeks Post-Treatment: Additive Model
Query!
Assessment method [25]
0
0
GWAS approach was used to evaluate the association of SNPs with treatment response. HBeAg seroconversion was defined as the loss of HBeAg and detection of anti-HBe. Undetectable HBV DNA was defined as an HBV DNA level below the LLD of 2000 IU/mL. HBsAg clearance was defined as the loss of HBsAg, with or without detection of anti-HBs. HBeAg seroconversion and undetectable HBV DNA were a combined criterion in treatment response. Associations with treatment response were analyzed using logistic regression and adjusted for covariates. Markers were coded according to additive models of inheritance. Markers surpassing p-value thresholds of p\<10\^-5 and p\<5x10\^-8 were considered suggestive and genome-wide significant, respectively. Larger beta coefficients correspond to greater likelihood of treatment response.
Query!
Timepoint [25]
0
0
Single blood sample =24 weeks post-treatment
Query!
Primary outcome [26]
0
0
SNPs Associated With HBeAg Seroconversion Plus Undetectable HBV DNA, HBsAg Clearance, or Undetectable HBV DNA =24 Weeks Post-Treatment: Dominant Model
Query!
Assessment method [26]
0
0
GWAS approach was used to evaluate the association of SNPs with treatment response. HBeAg seroconversion was defined as the loss of HBeAg and detection of anti-HBe. Undetectable HBV DNA was defined as an HBV DNA level below the LLD of 2000 IU/mL. HBsAg clearance was defined as the loss of HBsAg, with or without detection of anti-HBs. HBeAg seroconversion and undetectable HBV DNA were a combined criterion in treatment response. Associations with treatment response were analyzed using logistic regression and adjusted for covariates. Markers were coded according to dominant models of inheritance. Markers surpassing p-value thresholds of p\<10\^-5 and p\<5x10\^-8 were considered suggestive and genome-wide significant, respectively. Larger beta coefficients correspond to greater likelihood of treatment response.
Query!
Timepoint [26]
0
0
Single blood sample =24 weeks post-treatment
Query!
Primary outcome [27]
0
0
SNPs Associated With HBsAg Clearance =24 Weeks Post-Treatment in Non-CN Population: Additive Model
Query!
Assessment method [27]
0
0
GWAS approach was used to evaluate the association of SNPs with treatment response. HBsAg clearance was defined as the loss of HBsAg, with or without detection of anti-HBs. Associations with treatment response were analyzed using logistic regression and adjusted for covariates. Markers were coded according to additive models of inheritance. Markers surpassing p-value thresholds of p\<10\^-5 and p\<5x10\^-8 were considered suggestive and genome-wide significant, respectively. Larger beta coefficients correspond to greater likelihood of treatment response. Only a single SNP (rs12992677) was included in the analysis.
Query!
Timepoint [27]
0
0
Single blood sample =24 weeks post-treatment
Query!
Primary outcome [28]
0
0
SNPs Associated With HBsAg Clearance =24 Weeks Post-Treatment in Non-CN Population: Dominant Model
Query!
Assessment method [28]
0
0
GWAS approach was used to evaluate the association of SNPs with treatment response. HBsAg clearance was defined as the loss of HBsAg, with or without detection of anti-HBs. Associations with treatment response were analyzed using logistic regression and adjusted for covariates. Markers were coded according to dominant models of inheritance. Markers surpassing p-value thresholds of p\<10\^-5 and p\<5x10\^-8 were considered suggestive and genome-wide significant, respectively. Larger beta coefficients correspond to greater likelihood of treatment response. Only a single SNP (rs12992677) was included in the analysis.
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Timepoint [28]
0
0
Single blood sample =24 weeks post-treatment
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Primary outcome [29]
0
0
SNPs Associated With HBsAg Clearance =24 Weeks Post-Treatment in CN Population: Additive Model
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Assessment method [29]
0
0
GWAS approach was used to evaluate the association of SNPs with treatment response. HBsAg clearance was defined as the loss of HBsAg, with or without detection of anti-HBs. Associations with treatment response were analyzed using logistic regression and adjusted for covariates. Markers were coded according to additive models of inheritance. Markers surpassing p-value thresholds of p\<10\^-5 and p\<5x10\^-8 were considered suggestive and genome-wide significant, respectively. Larger beta coefficients correspond to greater likelihood of treatment response. Only a single SNP (rs7549785) was included in the analysis.
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Timepoint [29]
0
0
Single blood sample =24 weeks post-treatment
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Primary outcome [30]
0
0
SNPs Associated With HBsAg Clearance =24 Weeks Post-Treatment in CN Population: Dominant Model
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Assessment method [30]
0
0
GWAS approach was used to evaluate the association of SNPs with treatment response. HBsAg clearance was defined as the loss of HBsAg, with or without detection of anti-HBs. Associations with treatment response were analyzed using logistic regression and adjusted for covariates. Markers were coded according to dominant models of inheritance. Markers surpassing p-value thresholds of p\<10\^-5 and p\<5x10\^-8 were considered suggestive and genome-wide significant, respectively. Larger beta coefficients correspond to greater likelihood of treatment response. Only a single SNP (rs7549785) was included in the analysis.
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Timepoint [30]
0
0
Single blood sample =24 weeks post-treatment
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Primary outcome [31]
0
0
SNPs Associated With HBsAg Clearance =24 Weeks Post-Treatment: Additive Model
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Assessment method [31]
0
0
GWAS approach was used to evaluate the association of SNPs with treatment response. HBsAg clearance was defined as the loss of HBsAg, with or without detection of anti-HBs. Associations with treatment response were analyzed using logistic regression and adjusted for covariates. Markers were coded according to additive models of inheritance. Markers surpassing p-value thresholds of p\<10\^-5 and p\<5x10\^-8 were considered suggestive and genome-wide significant, respectively. Larger beta coefficients correspond to greater likelihood of treatment response.
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Timepoint [31]
0
0
Single blood sample =24 weeks post-treatment
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Primary outcome [32]
0
0
SNPs Associated With HBsAg Clearance =24 Weeks Post-Treatment: Dominant Model
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Assessment method [32]
0
0
GWAS approach was used to evaluate the association of SNPs with treatment response. HBsAg clearance was defined as the loss of HBsAg, with or without detection of anti-HBs. Associations with treatment response were analyzed using logistic regression and adjusted for covariates. Markers were coded according to dominant models of inheritance. Markers surpassing p-value thresholds of p\<10\^-5 and p\<5x10\^-8 were considered suggestive and genome-wide significant, respectively. Larger beta coefficients correspond to greater likelihood of treatment response. Only a single SNP (rs6592052) was included in the analysis.
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Timepoint [32]
0
0
Single blood sample =24 weeks post-treatment
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Eligibility
Key inclusion criteria
* Adults greater than or equal to (=) 18 years of age
* CHB
* Previously enrolled in a Roche study and treated for CHB for =24 weeks with Peg-IFN ± nucleoside analogue (lamivudine or entecavir) or Peg-IFN ± nucleotide analogue (adefovir) and with =24 weeks post-treatment follow-up; or
* Treated in general practice for CHB with Peg-IFN according to standard of care and in line with the current Summary of Product Characteristics (SmPC)/local labeling who have no contraindication to Peg-IFN therapy as per local label and have been treated with Peg-IFN for =24 weeks and have =24 week post-treatment response available at the time of blood sample collection
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
* Hepatitis A, hepatitis C, or human immunodeficiency virus (HIV) infection
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Study design
Purpose
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Duration
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Selection
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Timing
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
20/08/2013
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
28/11/2014
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Sample size
Target
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Accrual to date
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Final
1669
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Recruitment in Australia
Recruitment state(s)
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Recruitment outside Australia
Country [1]
0
0
Austria
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State/province [1]
0
0
Wien
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0
0
Bulgaria
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0
0
Sofia
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0
Bulgaria
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0
0
Varna
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0
0
China
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0
0
Beijing
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0
0
China
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0
0
Changsha
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0
0
China
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0
0
Chengdu
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0
0
China
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State/province [7]
0
0
Chongqing
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0
0
China
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State/province [8]
0
0
Fu Zhou
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0
0
China
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0
0
Guangzhou
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0
0
China
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State/province [10]
0
0
Hangzhou
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0
0
China
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0
0
Harbin
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0
0
China
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0
0
Jinan
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0
0
China
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0
0
Nanjing
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0
0
China
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0
0
Nanning
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0
0
China
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0
0
Shanghai
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0
0
China
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State/province [16]
0
0
Shen Zhen
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0
0
China
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State/province [17]
0
0
Shi Jiazhuang
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0
0
China
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0
0
Urumqi
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0
0
China
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0
Wuhan
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0
0
China
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0
Xi'an
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0
0
China
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0
Yinchuan
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0
China
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0
Zhengzhou
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0
0
France
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0
Clichy
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0
France
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0
Creteil
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France
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Rennes
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France
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Saint Laurent Du Var
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Germany
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Berlin
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Germany
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0
Hamburg
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Germany
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Hannover
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0
Greece
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Athens
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Greece
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Larissa
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Greece
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Thessaloniki
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Italy
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Campania
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Italy
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Emilia-Romagna
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Italy
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Lombardia
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Italy
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Puglia
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Italy
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Sardegna
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Italy
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Sicilia
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Italy
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Toscana
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Italy
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Veneto
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0
Korea, Republic of
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Busan
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0
Korea, Republic of
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Chooncheon
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Korea, Republic of
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Seoul
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New Zealand
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Auckland
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Poland
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Bydgoszcz
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Poland
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Chorzow
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Poland
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Krakow
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Poland
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Lancut
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Poland
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Warszawa
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Poland
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Zielona Góra
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Poland
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Lodz
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Portugal
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Lisboa
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Portugal
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Porto
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Romania
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Bucharest
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Romania
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Craiova
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Taiwan
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Changhua
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0
Taiwan
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0
Kaohsiung
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0
Taiwan
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0
Keelung City
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0
Taiwan
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Taichung
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0
Taiwan
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0
Taipei
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0
Taiwan
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State/province [61]
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0
Taoyuan
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0
0
Thailand
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State/province [62]
0
0
Bangkok
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Country [63]
0
0
Thailand
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State/province [63]
0
0
Chiang Mai
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Country [64]
0
0
Thailand
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State/province [64]
0
0
Songkhla
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0
0
United Kingdom
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State/province [65]
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0
London
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Country [66]
0
0
United Kingdom
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State/province [66]
0
0
Manchester
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
Hoffmann-La Roche
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief summary
This Phase 4 study is designed for the collection of blood biomarker samples from participants who have completed CHB treatment with at least 24 weeks of a pegylated interferon alfa-2a (Peg-IFN alfa-2a) containing regimen and at least 24 weeks post-treatment follow-up. Participants may be enrolled from historical studies supported or sponsored by Roche, ongoing studies supported or sponsored by Roche, or from general medical practice. The follow-up of individuals who choose to participate in this study will be in accordance with the ongoing studies or with the general medical practice of the physician. Data from whole blood deoxyribonucleic acid (DNA) samples collected in the GV28555 study or available from previously collected Roche Clinical Repository (RCR) samples will be used for combined analysis with data from other applicable studies. Procedures will include blood sample collection (not applicable for participants who previously have consented and donated RCR DNA samples) and medical record capture.
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Trial website
https://clinicaltrials.gov/study/NCT01855997
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Trial related presentations / publications
Wei L, Pavlovic V, Bansal AT, Chen X, Foster GR, He H, Kao JH, Lampertico P, Liaw YF, Motoc A, Papatheodoridis GV, Piratvisuth T, Plesniak R, Wat C. Genetic variation in FCER1A predicts peginterferon alfa-2a-induced hepatitis B surface antigen clearance in East Asian patients with chronic hepatitis B. J Viral Hepat. 2019 Sep;26(9):1040-1049. doi: 10.1111/jvh.13107. Epub 2019 Jul 23.
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Public notes
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Contacts
Principal investigator
Name
0
0
Clinical Trials
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Address
0
0
Hoffmann-La Roche
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Country
0
0
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Phone
0
0
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Fax
0
0
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Email
0
0
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Contact person for public queries
Name
0
0
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Address
0
0
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Country
0
0
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Phone
0
0
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Fax
0
0
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Email
0
0
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Contact person for scientific queries
No information has been provided regarding IPD availability
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results are available at
https://clinicaltrials.gov/study/NCT01855997
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