Trials / Completed
CompletedNCT01616524
Safety and Efficacy Study of Pegylated Interferon Lambda With and Without Daclatasvir, Compared to Pegylated Interferon Alfa, Plus Ribavirin in Subjects With Hepatitis C Genotype 2 and 3
A Phase 3, Randomized, Double-Blind, Controlled Study Evaluating the Efficacy and Safety of Peginterferon Lambda-1a, With and Without Daclatasvir, Compared to Peginterferon Alfa-2a, Each in Combination With Ribavirin, in the Treatment of Naïve Genotype 2 and 3 Chronic Hepatitis C Subjects
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 880 (actual)
- Sponsor
- Bristol-Myers Squibb · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this study is to determine if 24 weeks of treatment with Pegylated Interferon Lambda plus Ribavirin and 12 weeks of treatment with Pegylated Interferon Lambda plus Ribavirin and Daclatasvir will be safe and effective for treatment of hepatitis C compared to 24 weeks of treatment with Pegylated Interferon Alfa-2a plus Ribavirin
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | Pegylated interferon lambda (pegIFNλ) | Syringe, Subcutaneous, 180 μg, Once weekly, 24 weeks |
| BIOLOGICAL | Pegylated interferon lambda (pegIFNλ) | Syringe, Subcutaneous, 180 μg, Once weekly, 12 weeks |
| BIOLOGICAL | Pegylated interferon alfa-2a (pegIFNα-2a) | Syringe, Subcutaneous, 180 μg, Once weekly, 24 weeks |
| DRUG | Ribavirin | Tablets, Oral, 400 mg, Twice daily, 24 weeks |
| DRUG | Ribavirin | Tablets, Oral, 400 mg, Twice daily, 12 weeks |
| DRUG | Daclatasvir | Tablets, Oral, 60 mg, Once daily, 12 weeks |
| DRUG | Placebo matching Daclatasvir | Tablets, Oral, 0 mg, Once daily, 12 weeks |
Timeline
- Start date
- 2012-07-01
- Primary completion
- 2014-06-01
- Completion
- 2014-09-01
- First posted
- 2012-06-11
- Last updated
- 2015-10-09
Locations
124 sites across 19 countries: United States, Argentina, Australia, Belgium, Chile, Finland, France, Greece, Hong Kong, Italy, Japan, Mexico, Netherlands, New Zealand, Russia, Singapore, South Korea, Taiwan, United Kingdom
Source: ClinicalTrials.gov record NCT01616524. Inclusion in this directory is not an endorsement.