Safety and Efficacy of Boceprevir in Asia Pacific Participants With Chronic Hepatitis C Genotype 1 (P07063)
Summary
This study will assess the efficacy of boceprevir (BOC) in combination with PegIntron (pegylated interferon alfa-2b) (PEG) and ribavirin (RBV) in response guided therapy compared to the efficacy of standard-of-care therapy alone in adult subjects with chronic hepatitis C (CHC) genotype 1 who failed prior treatment with pegylated interferon and RBV in the Asia Pacific population. The primary hypothesis is that the proportion of participants achieving sustained virologic response in the experimental therapy regimen (BOC/PEG+RBV) is superior to that in the control arm (Placebo/PEG+RBV), in the Full Analysis Set (FAS) population.
Timeline
- Start
- 2011-10-21
- Primary completion
- 2015-06-19
- Completion
- 2015-06-19
Outcome
Met primary endpoint
registry Boceprevir - Korea+Taiwan vs Control - Korea+Taiwan; p <0.0001; Difference in Percentage 34.63 (95% CI 20.24 to 47.18) NCT01390844 ↗
registry Boceprevir - India vs Control - India; p = 0.0063; Difference in Percentage 33.83 (95% CI 10.15 to 52.18) NCT01390844 ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Boceprevir | Small molecule | 800 mg | Oral |
| Background | Peginterferon alfa-2b | Protein / enzyme biologic | 1.5 ug/kg | Subcutaneous |
| Background | Ribavirin | Small molecule | 800 mg | Oral |
| Background | Ribavirin | Small molecule | 1400 mg | Oral |