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Sponsored by: |
Schering-Plough |
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Information provided by: | Schering-Plough |
ClinicalTrials.gov Identifier: | NCT00705432 |
This study involves treatment with boceprevir or placebo in combination with PegIntron (PEG) + Ribavirin (RBV) (weight-based dosing [WBD]) in previously untreated adult subjects with chronic hepatitis C (CHC) genotype 1. This trial includes three arms, all of which have a 4-week lead-in period with PEG + RBV. There is one control arm (PEG + RBV + boceprevir placebo) for 44 weeks after the lead-in, and two experimental arms (PEG + RBV + boceprevir). One of the experimental arms consists of treatment with all three drugs for 44 weeks after the lead-in. The other experimental arm consists of all three drugs for 24 weeks after the lead-in. Those subjects in the second experimental arm who were undetectable for HCV-RNA at week 8 will complete treatment at that point. Those who were not undetectable for HCV-RNA at week 8 will receive an additional 20 weeks of PEG + RBV + boceprevir placebo. It is hypothesized that the addition of a third active anti-HCV drug may lead to more rapid viral response than therapy with two drugs, and therefore, the addition of boceprevir to PegIntron plus ribavirin therapy after a 4-week lead-in period may allow for both increased rates of SVR and shorter treatment durations (in some populations) than treatment with PegIntron/ribavirin alone.
Condition | Intervention | Phase |
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Hepatitis C, Chronic |
Drug: Boceprevir (SCH 503034) Biological: Peginterferon alfa-2b (SCH 54031) Drug: Ribavirin (SCH 18908) Drug: Boceprevir placebo |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Phase 3, Safety and Efficacy Study of Boceprevir in Previously Untreated Subjects With Chronic Hepatitis C Genotype 1 |
Estimated Enrollment: | 1080 |
Study Start Date: | August 2008 |
Estimated Study Completion Date: | June 2010 |
Estimated Primary Completion Date: | June 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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Arm 1: Placebo Comparator
PegIntron (PEG) 1.5 μg/kg + Ribavirin (RBV) (weight-based dosing [WBD]) for 4 weeks followed by placebo + PEG 1.5 μg/kg + RBV (WBD) for 44 weeks with 24 weeks post-treatment follow-up.
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Biological: Peginterferon alfa-2b (SCH 54031)
Peginterferon alfa-2b 1.5 μg/kg/week subcutaneously (SC)
Drug: Ribavirin (SCH 18908)
Ribavirin weight-based dosing (WBD) 600 mg/day to 1400 mg/day PO divided twice daily (BID).
Drug: Boceprevir placebo
Boceprevir placebo, 200 mg capsules, 800 mg TID PO.
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Arm 2: Experimental
PEG 1.5 μg/kg + RBV (WBD) for 4 weeks followed by boceprevir + PEG 1.5 μg/kg + RBV (WBD) for 24 weeks.
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Drug: Boceprevir (SCH 503034)
Boceprevir, 200 mg capsules, 800 mg three times a day (TID) orally (PO).
Biological: Peginterferon alfa-2b (SCH 54031)
Peginterferon alfa-2b 1.5 μg/kg/week subcutaneously (SC)
Drug: Ribavirin (SCH 18908)
Ribavirin weight-based dosing (WBD) 600 mg/day to 1400 mg/day PO divided twice daily (BID).
Drug: Boceprevir placebo
Boceprevir placebo, 200 mg capsules, 800 mg TID PO.
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Arm 3: Experimental
PEG 1.5 μg/kg + RBV (WBD) for 4 weeks followed by boceprevir + PEG 1.5 μg/kg + RBV (WBD) for 44 weeks with 24 weeks post-treatment follow-up.
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Drug: Boceprevir (SCH 503034)
Boceprevir, 200 mg capsules, 800 mg three times a day (TID) orally (PO).
Biological: Peginterferon alfa-2b (SCH 54031)
Peginterferon alfa-2b 1.5 μg/kg/week subcutaneously (SC)
Drug: Ribavirin (SCH 18908)
Ribavirin weight-based dosing (WBD) 600 mg/day to 1400 mg/day PO divided twice daily (BID).
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Responsible Party: | Schering-Plough ( Head, Clinical Trials Registry & Results Disclosure Group ) |
Study ID Numbers: | P05216, EUDRACT # 2007-005508-42 |
Study First Received: | June 24, 2008 |
Last Updated: | April 3, 2009 |
ClinicalTrials.gov Identifier: | NCT00705432 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Antimetabolites Interferon-alpha Liver Diseases Hepatitis, Chronic Interferons Ribavirin Hepatitis, Viral, Human Angiogenesis Inhibitors Antiviral Agents |
Hepatitis Virus Diseases Digestive System Diseases Peginterferon alfa-2b Hepatitis C Interferon Alfa-2a Hepatitis C, Chronic Interferon Alfa-2b |
Antimetabolites Anti-Infective Agents Liver Diseases Flaviviridae Infections Hepatitis, Chronic Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Ribavirin Physiological Effects of Drugs Hepatitis, Viral, Human Therapeutic Uses Hepatitis C Angiogenesis Modulating Agents |
Growth Inhibitors RNA Virus Infections Growth Substances Antiviral Agents Angiogenesis Inhibitors Pharmacologic Actions Virus Diseases Hepatitis Digestive System Diseases Peginterferon alfa-2b Interferon Alfa-2b Hepatitis C, Chronic |