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Sponsored by: |
Schering-Plough |
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Information provided by: | Schering-Plough |
ClinicalTrials.gov Identifier: | NCT00423800 |
This is a Phase IIIB randomized, controlled, multi-centre, open-label study of 24 vs 48 weeks therapy with peginterferon alfa-2b + ribavirin at standard doses in naïve HCV genotype 1 high viral load (HVL) patients who are HCV-RNA negative at Week 4. HVL will be defined as HCV-RNA of >600,000 IU/mL prior to the initiation of therapy. Patients with genotype 1 baseline HVL prescribed PEGETRON (peginterferon and ribavirin) in the usual manner in accordance with the marketing authorization and are viral negative at Week 4 will be randomized at Week 8 to receive a total of 24 or 48 weeks of therapy. Subjects will be required to have their baseline and week-12 viral load analyzed by the same local laboratory using the standard of care test used by the site. Qualitative testing at Week 4, 8, 16-20, 24, and 48 may be conducted either by local laboratory or a central laboratory identified by the sponsor using an assay specified by the sponsor. No additional interventions outside of the clinic's standard of care and the conditions of the Canadian product monograph for PEGETRON will be applied to subjects.
Condition | Intervention | Phase |
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Hepatitis C, Chronic |
Drug: Combination of pegylated interferon alfa-2b and ribavirin |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Dose Comparison, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Efficacy and Safety of 24 vs 48 Weeks of Pegetron® (Peginterferon Alfa-2b + Ribavirin) Therapy (1.5 Mcg/kg/Week + 800-1200 mg/Day) in Naïve Genotype 1 Hepatitis C Patients With High Baseline Viral Load Who Are HCV-RNA Negative at Week 4 and Week 12 |
Estimated Enrollment: | 212 |
Study Start Date: | December 2006 |
Estimated Study Completion Date: | June 2012 |
Estimated Primary Completion Date: | June 2012 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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Arm A: Experimental
Subjects are treated for 8 weeks and then randomized to an additional 16 weeks of treatment
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Drug: Combination of pegylated interferon alfa-2b and ribavirin
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Arm B: Active Comparator
Subjects are treated for 8 weeks and then randomized to an additional 40 weeks of treatment
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Drug: Combination of pegylated interferon alfa-2b and ribavirin
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Ages Eligible for Study: | 18 Years to 65 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: SP Clinical Trial Registry Call Center | 1-888-772-8734 |
Canada | |
Investigational Site 13 | Recruiting |
Kingston, Canada, K7L 5G2 | |
Investigational Site 14 | Recruiting |
Toronto, Canada, M4N 3M5 | |
Investigational Site 7 | Recruiting |
Winnipeg, Canada, R3E 3P4 | |
Investigational Site 21 | Completed |
Vancouver, Canada, V5Z 1H2 | |
Investigational Site 9 | Recruiting |
London, Canada, N6A 5R9 | |
Investigational Site 15 | Recruiting |
Toronto, Canada, M6H 3M1 | |
Investigational Site 27 | Recruiting |
Vancouver, Canada, V6A 4B6 | |
Investigational Site 19 | Completed |
Montreal, Canada, H3A 1A1 | |
Investigational Site 6 | Recruiting |
Edmonton, Canada, T5H 4B9 | |
Investigational Site 23 | Recruiting |
Halifax, Canada, B3H 1V7 | |
Investigational Site 24 | Recruiting |
Edmonton, Canada, T6G 2B7 | |
Investigational Site 18 | Recruiting |
Montreal, Canada, H3T 1E2 |
Responsible Party: | Schering-Plough ( Head, Clinical Trials Registry & Results Disclosure Group ) |
Study ID Numbers: | P05016 |
Study First Received: | January 17, 2007 |
Last Updated: | January 14, 2009 |
ClinicalTrials.gov Identifier: | NCT00423800 |
Health Authority: | Canada: Health Canada |
Interferon-alpha Liver Diseases Hepatitis, Chronic Interferons Ribavirin Hepatitis, Viral, Human Hepatitis |
Virus Diseases Digestive System Diseases Peginterferon alfa-2b Hepatitis C Interferon Alfa-2a Hepatitis C, Chronic Interferon Alfa-2b |
Antimetabolites Anti-Infective Agents RNA Virus Infections Molecular Mechanisms of Pharmacological Action Flaviviridae Infections Immunologic Factors Antineoplastic Agents Growth Substances |
Physiological Effects of Drugs Antiviral Agents Angiogenesis Inhibitors Pharmacologic Actions Therapeutic Uses Angiogenesis Modulating Agents Growth Inhibitors |