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Sponsored by: |
Schering-Plough |
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Information provided by: | Schering-Plough |
ClinicalTrials.gov Identifier: | NCT00708500 |
This study involves treatment with boceprevir or placebo in combination with PegIntron (PEG) + Ribavirin (RBV) (weight-based dosing [WBD]) in adult subjects with chronic hepatitis C (CHC) genotype 1 who demonstrated interferon responsiveness (a decrease in HCV-RNA viral load >=2 log10 by Week 12 or undetectable HCV-RNA at end of treatment) but who failed to achieve sustained virologic response (SVR) on prior treatment with any combination therapy of peginterferon alpha and ribavirin. This trial includes three arms, one control arm (PEG + RBV for 48 weeks) and two experimental arms (PEG + RBV + boceprevir). One of the experimental arms, Arm 3, consists of treatment with all three drugs for 44 weeks after the lead-in. The other experimental arm, Arm 2, consists of all three drugs for 32 weeks after the lead-in. Those subjects in Arm 2 who were undetectable for HCV-RNA at Treatment Week 8 will complete treatment at that point. Those who were not undetectable for HCV-RNA at Treatment Week 8 will receive an additional 12 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 peginterferon/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 Subjects With Chronic Hepatitis C Genotype 1 Who Failed Prior Treatment With Peginterferon/Ribavirin |
Estimated Enrollment: | 375 |
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) + Ribavirin (RBV) (weight-based dosing [WBD]) for 4 weeks followed by boceprevir placebo + PEG + 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
Subjects in Arm 2 will be assigned either a 36-week or 48-week course of therapy based on their HCV-RNA status at Treatment Week 8. PEG + RBV (WBD) for 4 weeks followed by boceprevir + PEG + RBV (WBD) for 32 weeks, then:
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Drug: Boceprevir (SCH 503034)
Boceprevir, 200 mg capsules, 800 mg TID 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 + RBV (WBD) for 4 weeks followed by boceprevir + PEG + 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 TID 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: | P05101, 2007-005151-42 |
Study First Received: | June 27, 2008 |
Last Updated: | January 6, 2009 |
ClinicalTrials.gov Identifier: | NCT00708500 |
Health Authority: | United States: Food and Drug Administration |
Treatment failure |
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 |