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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT00411385
Registration number
NCT00411385
Ethics application status
Date submitted
13/12/2006
Date registered
14/12/2006
Date last updated
8/08/2013
Titles & IDs
Public title
Efficacy of Albumin Interferon Alfa-2b With Ribavirin Compared to Peg-IFN Alfa-2a With Ribavirin in IFN Naive Patients Geno2/3
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Scientific title
Phase3 Study to Evaluate the Efficacy and Safety of AlbuminInterferon in Combination With Ribavirin Compared With Peginterferon in Combination With Ribavirin in Interferon Alfa Naive Subjects With CHC Genotype 2/3.
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Secondary ID [1]
0
0
ACHIEVE-2/3
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Secondary ID [2]
0
0
HGS1008-C1067
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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:
Chronic Hepatitis C
0
0
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Condition category
Condition code
Infection
0
0
0
0
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Other infectious diseases
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Oral and Gastrointestinal
0
0
0
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
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - albumin interferon alfa-2b
Treatment: Drugs - peginterferon alfa-2a
Treatment: Drugs - Ribavirin
Experimental: 1 - 900 mcg alb-IFN every 2 weeks (12 doses) + Ribavirin 800 micrograms per day
Experimental: 2 - 1200 mcg alb-IFN every 2 weeks (12 doses) + Ribavirin 800 micrograms per day
Active comparator: 3 - 180 mcg PEG-IFNx2a every 1 week (24 doses)+ Ribavirin 800 micrograms per day
Treatment: Drugs: albumin interferon alfa-2b
900 and 1200 micrograms Albumin Interferon Alpha 2a given subcutaneously once every two weeks for 24 weeks
Treatment: Drugs: peginterferon alfa-2a
180 micrograms Pegasys given subcutaneaously once a week for 24 weeks
Treatment: Drugs: Ribavirin
800mg/day for 24 weeks
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Intervention code [1]
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0
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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Sustained virologic response (SVR)
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Assessment method [1]
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Timepoint [1]
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Week 48
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Secondary outcome [1]
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Rapid virologic response
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Assessment method [1]
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0
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Timepoint [1]
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Week 4
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Early virologic response
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Assessment method [2]
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Timepoint [2]
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Week 12
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Secondary outcome [3]
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Undetectable HCV RNA
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Assessment method [3]
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0
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Timepoint [3]
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Week 24
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Secondary outcome [4]
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Normalization of ALT (a liver enzyme)
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Assessment method [4]
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Timepoint [4]
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Week 48
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Secondary outcome [5]
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Quality of life evaluation
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Assessment method [5]
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Timepoint [5]
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Week 48
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Secondary outcome [6]
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Safety assessments (physical exams, Ae reporting, lab testing/analysis, HADS and Immunogenicity results)
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Assessment method [6]
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Timepoint [6]
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Througout the entire treatment period
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Eligibility
Key inclusion criteria
Key
* Diagnosis of chronic hepatitis C.
* Liver biopsy performed within 2 years of Day 0 or during screening.
* Infected with hepatitis C virus genotype 2/3.
* Interferon alfa treatment naïve (ie, have never been treated with an interferon product).
* Subjects are eligible to enter the study if they (or their partners) are not pregnant or nursing, are sterile, or of non childbearing potential, or are willing to practice abstinence or use appropriate birth control methods during the study and for 7 months after the last dose of ribavirin.
* Have compensated liver disease.
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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
* Decompensated liver disease including those subjects with a past history or presence of ascites, bleeding varices or hepatic encephalopathy.
* History of moderate, severe or uncontrolled psychiatric disease, especially depression, including a history of hospitalization or prior suicidal attempt.
* Positive for human immunodeficiency virus (HIV-1) or hepatitis B surface antigen (HBsAG).
* Clinical diagnosis of other causes of chronic liver disease including but not limited to hepatitis B, autoimmune hepatitis, primary biliary cirrhosis, alcoholic liver disease, hemochromatosis, Wilson's Disease, or alpha 1-antitrypsin deficiency.
* A history of immunologically mediated disease (eg, rheumatoid arthritis, inflammatory bowel disease, moderate/severe psoriasis, sarcoidosis, systemic lupus erythematosus).
* Active seizure disorder within the last 2 years.
* Organ transplant other than cornea and hair transplant.
* Clinically significant hemoglobinopathy (eg, thalassemia, sickle cell anemia).
* Cancer within the last 5 years(with the exception of adequately treated basal cell carcinoma of the skin or in situ carcinoma of the uterine cervix).
* Drug or alcohol addiction within the last 6 months. Subjects in a supervised methadone treatment program may be enrolled in the study.
* Received any experimental agent within 28 days prior to Day 0.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled 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
Parallel
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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
1/02/2007
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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
1/10/2008
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Sample size
Target
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Accrual to date
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Final
933
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Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC,WA
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Recruitment hospital [1]
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Royal Prince Alfred Hospital - Camperdown
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Concord Repatriation General Hospital - Concord
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St George Hospital Clinical School of Medicine - Kogarah
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John Hunter Hospital - New Lambton
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Westmead Hospital - Westmead
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Gallipoli Research Foundation and Greenslopes Private Hospital - Greenslopes
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Royal Bribane & Women's Hospital - Herston
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Royal Adelaide Hospital - Adelaide
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Monash Medical Centre - Clayton
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St Vincent's Hospital - Fitzroy, Victoria
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Western Hospital - Footscray
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Austin Hospital - Heidelburg
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The Alfred Hospital - Melbourne
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Royal Melbourne Hospital - Parkville
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Fremantle Hospital - Fremantle
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2050 - Camperdown
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2139 - Concord
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2217 - Kogarah
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2305 - New Lambton
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2145 - Westmead
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4120 - Greenslopes
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4029 - Herston
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5000 - Adelaide
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3168 - Clayton
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3065 - Fitzroy, Victoria
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3011 - Footscray
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3081 - Heidelburg
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3004 - Melbourne
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3050 - Parkville
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6160 - Fremantle
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
Human Genome Sciences Inc.
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Address
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Other collaborator category [1]
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Commercial sector/industry
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Novartis
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Ethics approval
Ethics application status
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Summary
Brief summary
This is a phase 3, randomized, multi-center study to evaluate the efficacy and safety of albumin interferon alfa-2b (alb-IFN)in combination with ribavirin compared with peginterferon alfa-2a (PEGASYS or PEG-IFNa2a) in combination with ribavirin in subjects with chronic hepatitis C, genotype 2/3 who are IFNa treatment naive.
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Trial website
https://clinicaltrials.gov/study/NCT00411385
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Trial related presentations / publications
Bain VG, Yoshida EM, Kaita KD, Swain MG, Heathcote EJ, Garcia A, Moore PA, Yu R, McHutchison JG, Subramanian GM. Dynamics of interferon-specific gene expression in peripheral blood of interferon alfa-naive patients with genotype 1 chronic hepatitis C infection treated with albumin-interferon alfa. Hepatol Res. 2006 Aug;35(4):256-62. doi: 10.1016/j.hepres.2006.04.005. Epub 2006 May 30. Bain VG, Kaita KD, Yoshida EM, Swain MG, Heathcote EJ, Neumann AU, Fiscella M, Yu R, Osborn BL, Cronin PW, Freimuth WW, McHutchison JG, Subramanian GM. A phase 2 study to evaluate the antiviral activity, safety, and pharmacokinetics of recombinant human albumin-interferon alfa fusion protein in genotype 1 chronic hepatitis C patients. J Hepatol. 2006 Apr;44(4):671-8. doi: 10.1016/j.jhep.2005.12.011. Epub 2006 Jan 30. S. Zeuzem, , Y. Benhamou, , D. Shouval, , V. Bain, S. Pianko, , R. Flisiak, , M. Grigorescu, , V. Rehak, , E. Yoshida, K. Kaita, , C. Hezode, A.U. Neumann, M. Subramanian, J. McHutchison. Interim (Week 12) Phase 2B Virological Efficacy and Safety Results of albumin interferon alfa-2b Combined with Ribavirin in Genotype 1 Chronic Hepatitis C Infection. EASL, 2006 Vinod Rustgi, et al. A Dose-Escalation Study of albumin alfa-Ribavirin in Non-responders to Prior Interferon Based Therapy for Chronic Hepatitis C Infection Phase 2 Dose A Phase 2 Dose-Escalation Study of albumin interferon alfa interferon alfa-2b Combined with 2b Combined with Ribavirin in Non Non-responders to Prior Interferon. EASL, 2006 Balan V, Nelson DR, Sulkowski MS, Everson GT, Lambiase LR, Wiesner RH, Dickson RC, Post AB, Redfield RR, Davis GL, Neumann AU, Osborn BL, Freimuth WW, Subramanian GM. A Phase I/II study evaluating escalating doses of recombinant human albumin-interferon-alpha fusion protein in chronic hepatitis C patients who have failed previous interferon-alpha-based therapy. Antivir Ther. 2006;11(1):35-45. Nelson DR, Benhamou Y, Chuang WL, Lawitz EJ, Rodriguez-Torres M, Flisiak R, Rasenack JW, Kryczka W, Lee CM, Bain VG, Pianko S, Patel K, Cronin PW, Pulkstenis E, Subramanian GM, McHutchison JG; ACHIEVE-2/3 Study Team. Albinterferon Alfa-2b was not inferior to pegylated interferon-alpha in a randomized trial of patients with chronic hepatitis C virus genotype 2 or 3. Gastroenterology. 2010 Oct;139(4):1267-76. doi: 10.1053/j.gastro.2010.06.062. Epub 2010 Jul 1.
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