Trials / Completed
CompletedNCT02123654
UNITY 3: A Japanese Phase 3 Study of a Daclatasvir/Asunaprevir/BMS-791325 in Subjects With Genotype 1 Chronic Hepatitis C
A Japanese Phase 3 Study of a Daclatasvir/Asunaprevir/BMS-791325 Fixed Dose Combination (FDC) in Treatment-Naive and IFN Experienced Subjects With Genotype 1 Chronic Hepatitis C
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 297 (actual)
- Sponsor
- Bristol-Myers Squibb · Industry
- Sex
- All
- Age
- 20 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this study is to demonstrate that the proportion of treatment-naive non-cirrhotic subjects with Genotype (GT)-1b treated with Daclatasvir (DCV)/Asunaprevir (ASV)/BMS-791325 who achieve Sustained Virologic response (SVR12), defined as Hepatitis C virus (HCV) RNA \< LOQ target detected or target not detected (LOQ TD/TND) at follow-up Week 12, is significantly higher than SVR12 of current Standard of Care (SOC).
Detailed description
Limit of Quantitation (LOQ) Ribonucleic acid (RNA) End of Treatment (EOT) Triple Direct Acting Antivirals (3DAA)
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Daclatasvir | |
| DRUG | Asunaprevir | |
| DRUG | DCV 3DAA | |
| OTHER | Placebo for DCV 3DAA | |
| OTHER | Placebo for Daclatasvir | |
| OTHER | Placebo for Asunaprevir |
Timeline
- Start date
- 2014-04-01
- Primary completion
- 2015-01-01
- Completion
- 2015-08-01
- First posted
- 2014-04-25
- Last updated
- 2015-09-18
Locations
35 sites across 1 country: Japan
Source: ClinicalTrials.gov record NCT02123654. Inclusion in this directory is not an endorsement.