Trials / Completed
CompletedNCT01371604
Safety and Antiviral Activity of IDX184 in Combination With Pegylated Interferon and Ribavirin for 12 Weeks (MK-2355-005)
A Randomized, Double-Blind Study to Evaluate the Safety and Antiviral Activity of IDX184 in Combination With Pegylated Interferon and Ribavirin for 12 Weeks in Treatment-Naïve Subjects With Genotype 1 Chronic Hepatitis C Infection
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 68 (actual)
- Sponsor
- Merck Sharp & Dohme LLC · Industry
- Sex
- All
- Age
- 18 Years – 65 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this study is to assess the safety and antiviral activity of IDX184 in combination with pegylated interferon and ribavirin in treatment-naïve subjects with genotype 1 chronic hepatitis C virus (HCV) infection.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | IDX184 | IDX184 50 mg tablet administered orally |
| BIOLOGICAL | Peginterferon alfa-2a (Peg-IFN) | Peginterferon alfa-2 180 microgram prefilled syringe administered subcutaneously once weekly |
| DRUG | Ribavirin (RBV) | Ribavirin 200 mg tablets administered orally as a divided dose twice daily. Total daily dose to administered will be 1000 or 1200 mg based on body weight. |
| DRUG | Placebo | Matching placebo to IDX184 50 mg tablet administered orally |
Timeline
- Start date
- 2011-07-01
- Primary completion
- 2013-03-01
- Completion
- 2014-10-01
- First posted
- 2011-06-13
- Last updated
- 2015-02-06
Source: ClinicalTrials.gov record NCT01371604. Inclusion in this directory is not an endorsement.