Trials / Completed
CompletedNCT01425203
The Effect of Boceprevir in Russian Participants Diagnosed With Chronic Hepatitis C Genotype 1 (P08160)
Safety and Efficacy of Boceprevir in Combination With Peginterferon Alfa-2b Plus Ribavirin for Treatment of Chronic Hepatitis C Genotype 1 in Russia: Previously Untreated Patients and Patients Who Failed Prior Treatment With Pegylated-Interferon Plus Ribavirin
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 238 (actual)
- Sponsor
- Merck Sharp & Dohme LLC · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this study is to determine whether Boceprevir (BOC, SCH 503034, MK-3034) in combination with Peginterferon Alfa 2-b (PEG) plus Ribavirin (RBV) \[PEG+RBV=PR\] is effective in the treatment of chronic hepatitis C (CHC) genotype 1 among the Russian population. The primary hypothesis is that the percentage of participants achieving sustained virologic response in the BOC + PR group is superior to that in the Placebo (PBO) + PR group.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Boceprevir | boceprevir 200-mg capsules, 800 mg 3 times a day (TID), orally (PO) |
| DRUG | Placebo | boceprevir-matched placebo four 200-mg capsules PO TID. |
| BIOLOGICAL | peginterferon alfa-2b | peginterferon alfa-2b 1.5 μg/kg/wk subcutaneously (SC) |
| DRUG | Ribavirin | ribavirin (weight-based dosing) 800 to 1400 mg/day PO divided twice daily dose (BID). |
Timeline
- Start date
- 2011-11-23
- Primary completion
- 2013-10-21
- Completion
- 2013-10-21
- First posted
- 2011-08-29
- Last updated
- 2021-02-08
- Results posted
- 2014-08-18
Source: ClinicalTrials.gov record NCT01425203. Inclusion in this directory is not an endorsement.