Trials / Completed
CompletedNCT01573351
Phase III Hallmark QUAD: ASV+DCV+Peg+Rib (Nulls/Partials)
A Phase 3, Open-Label Study With Asunaprevir and Daclatasvir Plus Peginterferon Alfa-2a (Pegasys) and Ribavirin (Copegus) (P/R) (QUAD) for Subjects Who Are Null or Partial Responders to Peginterferon Alfa 2a or 2b Plus Ribavirin With Chronic Hepatitis C Genotypes 1 or 4 Infection
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 398 (actual)
- Sponsor
- Bristol-Myers Squibb · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this study is to assess efficacy, as determined by the proportion of subjects with Sustained Virologic Response at Post-Treatment Week 12 (SVR12), defined as Hepatitis C virus (HCV) Ribonucleic acid (RNA) \< Limit of quantitation (LOQ) at post-treatment Week 12.
Detailed description
* ASV = Asunaprevir (BMS-650032) * DCV = Daclatasvir (BMS-790052) * Peg = Peg-interferon Alfa-2a (PegIFN) * Rib = Ribavirin (RBV)
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Asunaprevir | |
| DRUG | Daclatasvir | |
| DRUG | Peg-interferon Alfa-2a | |
| DRUG | Ribavirin |
Timeline
- Start date
- 2012-05-01
- Primary completion
- 2013-09-01
- Completion
- 2013-12-01
- First posted
- 2012-04-09
- Last updated
- 2015-10-09
Locations
79 sites across 15 countries: United States, Argentina, Canada, Denmark, France, Germany, Italy, Mexico, Netherlands, Russia, South Korea, Spain, Sweden, Switzerland, Taiwan
Source: ClinicalTrials.gov record NCT01573351. Inclusion in this directory is not an endorsement.