Last reviewed · How we verify
PEG-Intron/REBETOL vs PEG-Intron/ SCH 503034 With and Without Ribavirin in Chronic Hepatitis C Virus Genotype 1 (HCV-1) Peginterferon Alfa/Ribavirin Nonresponders: A SCH 503034 Dose-Finding Phase 2 Study
The primary objective of this study is to determine the safe and effective dose range of boceprevir (SCH 503034) in combination with PEG-Intron in adult subjects who have chronic hepatitis C without cirrhosis, and who have failed an adequate course of combination therapy with peginterferon-alfa plus ribavirin. A secondary objective is to explore whether ribavirin provides an additional benefit when combined with PEG-Intron plus boceprevir.
Details
| Lead sponsor | Merck Sharp & Dohme LLC |
|---|---|
| Phase | Phase 2 |
| Status | COMPLETED |
| Enrolment | 357 |
| Start date | 2005-09 |
| Completion | 2007-07 |
Conditions
- Chronic Hepatitis C
Interventions
- Boceprevir (BOC)
- PegIntron (PEG)
- Ribavirin (RBV)
Primary outcomes
- Percent of Participants Who Were Hepatitis C Virus Ribonucleic Acid (HCV-RNA) Negative at the End of Treatment (EoT) — Baseline up to Week 49
Sustained Viral Response (SVR) was defined as the percentage of participants with HCV-RNA undetectable at the follow-up Week 24. All percentages were based on the total number of participants originally randomized/enrolled to that particular arm. For Arm 1B, the denominator for the percentages was the number who received at least 1 dose of BOC. Arm 1A was not analyzed. - Percent of Participants Who Achieved Sustained Virologic Response (SVR) — Baseline up to Week 73 [24 weeks after end of treatment (EoT)]
SVR was defined as the percentage of participants with Hepatitis C Virus Ribonucleic Acid (HCV-RNA) undetectable at the follow-up Week 24. All percentages were based on the total number of participants originally randomized/enrolled to that particular arm. For Arm 1B, the denominator for the percentages was the number who received at least 1 dose of BOC. Arm 1A was not analyzed.