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Sponsors and Collaborators: |
Schering-Plough Integrated Therapeutics Group |
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Information provided by: | Schering-Plough |
ClinicalTrials.gov Identifier: | NCT00302081 |
This is a randomized, open-label, multinational study designed to evaluate the "standard" regimen, PEG-Intron 1.5 µg/kg subcutaneously once weekly plus ribavirin 800-1200 mg daily (Arm A), compared to a lower dose regimen, PEG-Intron 1.0 µg/kg subcutaneously once weekly plus ribavirin 800-1200 mg daily (Arm B), using a 24 week treatment duration for both arms. Additionally, the study will examine the efficacy of reduced treatment duration: PEG-Intron 1.5 µg/kg subcutaneously once weekly plus ribavirin 800-1200 mg for 16 weeks (Arm C).
Condition | Intervention | Phase |
---|---|---|
Hepatitis C, Chronic |
Biological: peginterferon alfa-2b (SCH 54031) Drug: ribavirin (SCH 54031) |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Dose Comparison, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Comparison of Three Regimens of PEG-Intron and Ribavirin in the Treatment of Chronic Hepatitis C, Genotype 2 or 3, in Previously Untreated Patients |
Estimated Enrollment: | 667 |
Study Start Date: | December 2005 |
Study Completion Date: | March 2008 |
Primary Completion Date: | March 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
Arm A: Experimental
PegIntron (peginterferon alfa-2b; SCH 54031) 1.5 mcg/kg QW SC plus ribavirin (SCH 18908) 800-1200 mg daily for 24 weeks
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Biological: peginterferon alfa-2b (SCH 54031)
1.5 mcg/kg QW SC for 24 weeks
Drug: ribavirin (SCH 54031)
800-1200 mg daily for 24 weeks
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Arm B: Experimental
PegIntron (peginterferon alfa-2b; SCH 54031) 1.0 mcg/kg QW SC plus ribavirin (SCH 18908) 800-1200 mg/day for 24 weeks
|
Biological: peginterferon alfa-2b (SCH 54031)
1.0 mcg/kg QW SC for 24 weeks
Drug: ribavirin (SCH 54031)
800-1200 mg daily for 24 weeks
|
Arm C: Experimental
PegIntron (peginterferon alfa-2b; SCH 54031) 1.5 mcg/kg QW SC plus ribavirin (SCH 18908) 800-1200 mg/day for 16 weeks
|
Biological: peginterferon alfa-2b (SCH 54031)
1.5 mcg/kg QW SC for 24 weeks
Drug: ribavirin (SCH 54031)
800-1200 mg daily for 16 weeks
|
This is a randomized, open-label, multinational study designed to evaluate the "standard" regimen, PEG-Intron 1.5 µg/kg subcutaneously once weekly plus ribavirin 800-1200 mg daily (Arm A), will be compared to a lower dose regimen, PEG-Intron 1.0 µg/kg subcutaneously once weekly plus ribavirin 800-1200 mg daily (Arm B), using a 24 week treatment duration for both arms. Additionally, the study will examine the efficacy of reduced treatment duration: PEG-Intron 1.5 µg/kg subcutaneously once weekly plus ribavirin 800-1200 mg for 16 weeks (Arm C).
Ages Eligible for Study: | 18 Years to 70 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
The subject must meet ALL of the criteria listed below for entry into the study:
Exclusion Criteria:
Any cause of liver disease other than chronic hepatitis C, including but not limited to:
Any known preexisting medical condition that could interfere with the subject's participation in and completion of study, such as:
Responsible Party: | Schering-Plough ( Edward Power, PhD - Senior Global Medical Director, Global Medical Affairs ) |
Study ID Numbers: | P03548 |
Study First Received: | March 10, 2006 |
Last Updated: | May 28, 2008 |
ClinicalTrials.gov Identifier: | NCT00302081 |
Health Authority: | Austria: Federal Ministry for Health and Women; Belgium: Ministry of Social Affairs, Public Health and the Environment; Germany: Federal Institute for Drugs and Medical Devices; France: Afssaps - French Health Products Safety Agency; Portugal: National Pharmacy and Medicines Institute; Israel: Israeli Health Ministry Pharmaceutical Administration; India: Ministry of Health |
Hepatitis C, Chronic Genotype 2 and Genotype 3 |
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 Flaviviridae Infections Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Growth Substances |
Physiological Effects of Drugs Antiviral Agents Angiogenesis Inhibitors Pharmacologic Actions Therapeutic Uses Growth Inhibitors Angiogenesis Modulating Agents |