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Sponsored by: |
Schering-Plough |
Information provided by: | Schering-Plough |
ClinicalTrials.gov Identifier: | NCT00255034 |
This is an Australian, open-label, multicenter, randomized, double-blind clinical trial designed to assess the efficacy of combination therapy with pegylated interferon alfa-2b and ribavirin for 48 weeks versus 24 weeks in the treatment of chronic hepatitis C (treatment-naïve genotype 3 subjects with high viral loads who have a METAVIR score of at least F1A2). The primary endpoint will be a sustained virological response defined by undetectable HCV RNA in serum at 24 weeks after completion of therapy.
Condition | Intervention | Phase |
Hepatitis C, Chronic |
Drug: Combination of pegylated interferon alfa-2b and ribavirin |
Phase IV |
MedlinePlus related topics: | Hepatitis Hepatitis C |
Drug Information available for: | Ribavirin Interferon alfa-n1 Interferon alfa-2a Interferon alfa-2b Interferons Peginterferon Alfa-2b |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Dose Comparison, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Phase IV Study of Tailored Therapy With Peg Interferon Alfa 2b and Ribavirin for Patients With Genotype 3 and High Viral Load. Genotype 3 Extended Treatment for HCV (GET-C Study) |
Estimated Enrollment: | 624 |
Study Start Date: | February 2005 |
Estimated Study Completion Date: | August 2008 |
Estimated Primary Completion Date: | August 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
24 weeks of therapy: Active Comparator
Genotype 3 HCV subjects with high viral load (at least 2 million copies/mL) treated for 24 weeks
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Drug: Combination of pegylated interferon alfa-2b and ribavirin
(a) Powder for injection in Redipen (50, 80, 100, 120 and 150 microgram strengths), subcutaneous, dose of 1.5 micrograms/kg, weekly for up to 24 or 48 weeks (g) 200 mg capsules, oral, weight-based dose of 800, 1000, or 1200 mg, daily for up to 24 or 48 weeks
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48 weeks of therapy: Experimental
Genotype 3 HCV subjects with high viral load (at least 2 million copies/mL) treated for 48 weeks
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Drug: Combination of pegylated interferon alfa-2b and ribavirin
(a) Powder for injection in Redipen (50, 80, 100, 120 and 150 microgram strengths), subcutaneous, dose of 1.5 micrograms/kg, weekly for up to 24 or 48 weeks (g) 200 mg capsules, oral, weight-based dose of 800, 1000, or 1200 mg, daily for up to 24 or 48 weeks
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Compensated liver disease with the following minimum hematologic and biochemical criteria:
Exclusion Criteria:
Responsible Party: | Schering-Plough ( Leanne Wall, MD - Medical Director, Australia Country Operations ) |
Study ID Numbers: | P04143 |
First Received: | November 15, 2005 |
Last Updated: | March 20, 2008 |
ClinicalTrials.gov Identifier: | NCT00255034 |
Health Authority: | Australia: Department of Health and Ageing Therapeutic Goods Administration |
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