Trials / Completed
CompletedNCT01945294
Short Duration Versus Standard Response-Guided Therapy With Boceprevir Combined With PegIntron and Ribavirin in Previously Untreated Non-Cirrhotic Asian Participants With Chronic HCV Genotype 1 (MK-3034-107)
A Phase 3 Clinical Trial to Study Short Duration Versus Standard Response-Guided Therapy With MK-3034 (SCH 503034)/Boceprevir Combined With PegIntron and Ribavirin in Previously Untreated Non-Cirrhotic Subjects With Chronic HCV Genotype 1 in Asia
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 257 (actual)
- Sponsor
- Merck Sharp & Dohme LLC · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this study is to estimate the difference in the efficacy between a 16-week treatment regimen of boceprevir (BOC) in combination with peg-intron alpha 2b (P) plus ribavirin (R) (BOC + PR) and a 28-week treatment regimen of BOC + PR in previously untreated participants with chronic hepatitis C (CHC) genotype 1 in Asia who achieve undetectable hepatitis C virus ribonucleic acid (HCV RNA).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Boceprevir | 800 mg three times daily orally |
| BIOLOGICAL | Peg-interferon alfa-2b | 1.5 mcg/kg weekly subcutaneously |
| DRUG | Ribavirin | 800-1400 mg twice-daily divided orally based on body weight |
Timeline
- Start date
- 2013-10-10
- Primary completion
- 2015-08-05
- Completion
- 2015-11-04
- First posted
- 2013-09-18
- Last updated
- 2018-07-12
- Results posted
- 2016-11-23
Source: ClinicalTrials.gov record NCT01945294. Inclusion in this directory is not an endorsement.