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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT00395018
Registration number
NCT00395018
Ethics application status
Date submitted
1/11/2006
Date registered
2/11/2006
Date last updated
31/05/2012
Titles & IDs
Public title
Antiviral Activity of Entecavir in Patients Receiving Liver Transplant Due to Chronic Hepatitis B Virus Infection
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Scientific title
Study of the Antiviral Activity of Entecavir in Patients Receiving Liver Transplant Due to Chronic Hepatitis B Virus Infection
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Secondary ID [1]
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AI463-109
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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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Condition category
Condition code
Infection
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Other infectious diseases
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Oral and Gastrointestinal
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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
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - entecavir
Experimental: entecavir -
Treatment: Drugs: entecavir
Tablets, Oral, 1 mg, once daily, up to 72 weeks
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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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Percentage of Participants With HBV Deoxyribonucleic Acid (DNA) => 50 IU/mL by Polymerase Chain Reaction (PCR) at Week 72
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Assessment method [1]
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HBV DNA assessments were performed using the Roche COBAS® TaqMan High+Pure system (HPS) assay. HBV DNA =\> 50 IU/mL = approximately =\> 300 copies/mL.
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Timepoint [1]
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At 72 weeks
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Primary outcome [2]
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Number of Participants With HBV DNA by PCR >= 50 IU/mL Through Week 72
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Assessment method [2]
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HBV DNA assessments were performed using the Roche COBAS® TaqMan High+Pure system (HPS) assay. HBV DNA =\> 50 IU/mL = approximately =\> 300 copies/mL.
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Timepoint [2]
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At baseline (day 1), week 12, 24, 36, 48, 60, and 72
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Secondary outcome [1]
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Distribution of ALT Levels Through 72 Weeks: Overall
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Assessment method [1]
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ALT is an enzyme present in serum and various tissues of the body, associated commonly with the liver. Elevated levels of ALT often suggests existence of medical problems which includes viral hepatitis. Normal range varies from laboratory to laboratory. Values of 5-60 U/L is usually considered normal. ALT abnormality = \>1.25 x ULN (upper limit of normal).
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Timepoint [1]
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On Day 1 (baseline) and at week 4, 12, 24, 36, 48, 60, 72
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Secondary outcome [2]
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Percentage of Participants With HBV DNA < 50 IU/mL (Approximately 300 Copies/mL) by PCR at the End of Post-dosing Follow-up
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Assessment method [2]
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HBV DNA assessments were to be performed using the Roche COBAS® TaqMan AmpliPrep assay. HBV DNA \< 50 IU/mL = approximately 300 copies/mL.
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Timepoint [2]
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At 72 weeks + 24 weeks follow-up
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Secondary outcome [3]
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Percentage of Participants With HBeAg Loss at Week 72 (for HBeAg-positive Participants)
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Assessment method [3]
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HBeAg is a hepatitis B viral protein. HBeAg loss = HBeAg-negative at the specified analysis week.
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Timepoint [3]
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At week 72
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Secondary outcome [4]
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Percentage of Participants With HBeAg Seroconversion at Week 72 (for HBeAg-positive Participants)
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Assessment method [4]
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HBeAg is a hepatitis B viral protein. HBeAg Seroconversion = HBeAg Loss and Presence of Hepatitis B e Antibody (HBeAb).
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Timepoint [4]
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At week 72
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Secondary outcome [5]
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Percentage of Participants With HBsAg Loss at Week 72
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Assessment method [5]
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HBsAg = a part of the hepatitis B virus that, when in the blood, is an early marker of infection. HBsAg loss = HBsAg-negative at the specified analysis week.
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Timepoint [5]
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At week 72
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Secondary outcome [6]
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Percentage of Participants With HBsAg Seroconversion at Week 72
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Assessment method [6]
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HBsAg = a part of the hepatitis B virus that, when in the blood, is an early marker of infection. HBs seroconversion is defined as HBsAg loss with positive HBsAb.
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Timepoint [6]
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At week 72
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Secondary outcome [7]
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Percentage of Participants With HBsAg Recurrence At Week 72
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Assessment method [7]
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HBsAg = a part of the hepatitis B virus that, when in the blood, is an early marker of infection. HBsAg recurrence is defined as having detectable HBsAg among participants who have already experienced loss of HBsAg on-treatment. HBsAg recurrence = HBsAg-positive at the specified analysis week.
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Timepoint [7]
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At week 72
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Secondary outcome [8]
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Total Bilirubin at Week 72
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Assessment method [8]
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Bilirubin measures are used to diagnose or monitor liver functioning or diseases that include hepatitis. Viral hepatitis is one of the condition in which bilirubin levels are elevated. Normal range varies from laboratory to laboratory. Bilirubin abnormality : =\> 1.1 x ULN mg/dL.
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Timepoint [8]
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At week 72
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Secondary outcome [9]
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Prothrombin Time (PT) at Week 72
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Assessment method [9]
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Prothrombin, a liver protein, plays an important role in the extrinsic pathway of clotting. Increased prothrombin time indicates abnormal liver functioning. Normal prothrombin time varies from laboratory to laboratory. Generally, normal prothrombin time varies between 10 to 13.2 seconds. Abnormal PT: \> 1.01 x ULN.
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Timepoint [9]
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At week 72
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Secondary outcome [10]
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Number of Participants With Liver Rejection Through Week 72
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Assessment method [10]
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Timepoint [10]
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Through week 72
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Secondary outcome [11]
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Number of Participants With Re-transplantation Through Week 72
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Assessment method [11]
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Timepoint [11]
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Through week 72
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Secondary outcome [12]
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Participants With Adverse Events (AE), Serious Adverse Events (SAE), and Discontinuations From Study Drug Due to AEs (On-treatment [OT] and Off-treatment Follow-up [OF])
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Assessment method [12]
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AE: any new untoward medical occurrence/worsening of pre-existing medical condition, whether or not related to study drug. SAE: any AE that resulted in death; was life threatening; resulted in persistent/significant disability/incapacity; resulted in/prolonged an existing in-patient hospitalization; was a congenital anomaly/birth defect; or an overdose. Toxicity grading by modified WHO grade system. Grade (GR) 2=moderate; GR3=severe; GR4=very severe. OT=from start of dosing to end of dosing+5 days; OF=from end of dosing+6 days to start of other anti-HBV therapy or end of follow-up.
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Timepoint [12]
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OT:From start of dosing through Week 72 + 5 days; OF:End of OT through 24-weeks follow-up
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Secondary outcome [13]
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Number of Participants With Laboratory Abnormalities On-treatment (OT) and Off-Treatment Follow-up(OF): Hematology (All Grades)
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Assessment method [13]
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Criteria for hematology abnormalities were: Hemoglobin : \<11.0 g/dL; White Blood Cells : \<4000/mm\^3; Neutrophils : \<1500/mm\^3; Platelets : \< 99,000/mm\^3; International Normalized Ratio (INR) : increase \>= 0.5 from baseline.
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Timepoint [13]
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OT:From start of dosing through Week 72 + 5 days; OF:End of OT through 24-weeks follow-up
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Secondary outcome [14]
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Number of Participants With Laboratory Abnormalities On-treatment (OT) and Off-Treatment (OF) Follow-up: Serum Chemistry (All Grades)
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Assessment method [14]
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Normal ranges are local lab data and vary according to the site. Criteria for laboratory abnormalities:ALT:\>1.25xULN;AST:\>1.25xULN;ALP:\>1.25xULN;Total Bilirubin:\>1.1xULN;Serum Lipase:\>1.10xULN;Creatinine:\>1.1xULN;Blood Urea Nitrogen:\>1.25xULN;Hyperglycemia:\>116mg/dL;Hypoglycemia:\<64mg/dL;Hyponatremia:\<132meq/L;Hypernatremia:\>148meq/L;Hypokalemia:\<3.4meq/L;hyperkalemia:\>5.6meq/L;Hypochloremia:\<93meq/L;Hyperchloremia:\>113meq/L;Albumin: Decrease \>= 1g/dL from baseline and \< 3 g/dL. HYPER=value\>ULN(upper limit of normal). HYPO=value\<LLN (lower limit of normal).
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Timepoint [14]
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OT:From start of dosing through Week 72 + 5 days; OF:End of OT through 24-weeks follow-up
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Eligibility
Key inclusion criteria
* Patients receiving orthotopic liver transplant (OLT) due to end-stage liver disease because of chronic HBV infection, with HBV-DNA < 172 IU/mL (approximately < 1000 copies/mL) prior to liver transplant
* Must have detectable hepatitis B surface antigen (HBsAg) at screening and for at least 24 weeks prior to screening
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Minimum age
16
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
* Patients with hepatocellular carcinoma with evidence of extrahepatic spread, multiple tumors = 6.5 cm in diameter or there is up to three nodules = 4.5 cm in diameter and total tumor diameter is = 8 cm
* Co-infection with human immunodeficiency virus (HIV), cytomegalovirus (CMV), Epstein-Barr virus (EBV) or hepatitis C virus (HCV)
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Study design
Purpose of the study
Prevention
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Allocation to intervention
Non-randomised trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Single group
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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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
1/04/2007
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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
1/03/2011
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Sample size
Target
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Accrual to date
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Final
109
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Recruitment in Australia
Recruitment state(s)
QLD,VIC
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Recruitment hospital [1]
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Local Institution - Woolloongabba
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Recruitment hospital [2]
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Local Institution - Heidelberg
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Recruitment postcode(s) [1]
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4102 - Woolloongabba
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Recruitment postcode(s) [2]
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3084 - Heidelberg
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Recruitment outside Australia
Country [1]
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United States of America
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State/province [1]
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Illinois
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Country [2]
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United States of America
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State/province [2]
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Louisiana
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Country [3]
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United States of America
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State/province [3]
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Minnesota
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Country [4]
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United States of America
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State/province [4]
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Nebraska
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Country [5]
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United States of America
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State/province [5]
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New York
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Country [6]
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United States of America
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State/province [6]
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Ohio
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Country [7]
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United States of America
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State/province [7]
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Texas
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Country [8]
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Argentina
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State/province [8]
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Buenos Aires
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Country [9]
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Brazil
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State/province [9]
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Ceara
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Country [10]
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Brazil
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State/province [10]
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Rio Grande Do Sul
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Country [11]
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Brazil
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State/province [11]
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Sao Paulo
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Country [12]
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France
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State/province [12]
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Clichy Cedex
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Country [13]
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France
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State/province [13]
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Paris Cedex 12
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Country [14]
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France
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State/province [14]
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Villejuif
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Country [15]
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Italy
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State/province [15]
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Bologna
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Country [16]
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Italy
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State/province [16]
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Roma
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Country [17]
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Italy
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State/province [17]
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Torrette Di Ancona
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Country [18]
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Korea, Republic of
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State/province [18]
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Seoul
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Country [19]
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Spain
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State/province [19]
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Barcelona
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Spain
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State/province [20]
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Madrid
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Spain
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State/province [21]
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Valencia
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Country [22]
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Taiwan
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State/province [22]
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Kaohsiung
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Country [23]
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Taiwan
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State/province [23]
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Taipei
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
Bristol-Myers Squibb
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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
The purpose of this clinical research study is to learn if the study drug entecavir will prevent the recurrence of hepatitis B virus (HBV) in participants who receive an orthotopic liver transplant (OLT) due to HBV infection.
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Trial website
https://clinicaltrials.gov/study/NCT00395018
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Bristol-Myers Squibb
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Address
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Bristol-Myers Squibb
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Country
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Phone
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Fax
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Email
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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/NCT00395018
Download to PDF