Trials / Completed
CompletedNCT01011166
Safety and Antiviral Activity of IDX184 in Combination With Pegylated Interferon and Ribavirin (MK-2355-004)
A Phase II, Randomized, Double-Blind Study to Evaluate the Safety and Antiviral Activity of IDX184 in Combination With Pegylated Interferon and Ribavirin in Subjects With Genotype 1 Chronic Hepatitis C Infection
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 81 (actual)
- Sponsor
- Merck Sharp & Dohme LLC · Industry
- Sex
- All
- Age
- 18 Years – 65 Years
- Healthy volunteers
- Not accepted
Summary
This study will assess short term safety, antiviral activity and pharmacokinetics (PK) of IDX184 in combination with Peg-interferon (Peg-IFN)/Ribavirin (RBV) in participants with hepatitis C virus (HCV) genotype (GT) 1 infection. These data will guide dose selection for future, longer term studies.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | IDX184 | IDX184 50 mg white opaque capsules taken by mouth from Day 1 to Day 14. |
| DRUG | Placebo | Placebo white opaque capsules taken by mouth from Day 1 to Day 14. |
| BIOLOGICAL | Peginterferon alfa-2a (Peg-IFN) | Peg-IFN was supplied as 180 ug single-use, pre-filled syringes administered once weekly from Day 1 to Day 28. |
| DRUG | Ribavirin (RBV) | RBV 200 mg capsules at a total daily dose of 1000 mg to 1200 mg (based on participant body weight) from Day 1 to Day 28. |
Timeline
- Start date
- 2009-11-01
- Primary completion
- 2010-07-01
- Completion
- 2010-07-01
- First posted
- 2009-11-11
- Last updated
- 2015-04-23
Source: ClinicalTrials.gov record NCT01011166. Inclusion in this directory is not an endorsement.