Rapid Hepatitis C Elimination Trial- A Pilot Study of Daclatasvir/Asunaprevir/BMS-791325 With or Without Ribavirin To Treat Hepatitis C Virus
| Status: | Completed |
|---|---|
| Conditions: | Hepatitis, Hepatitis |
| Therapuetic Areas: | Immunology / Infectious Diseases |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 4/21/2016 |
| Start Date: | July 2014 |
| End Date: | February 2016 |
RHACE 1: Rapid HepAtitis C Elimination Trial - A Pilot Evaluation of Twice Daily Fixed Dose Combination Asunaprevir +Daclatasvir + BMS-791325 ± Weight Based Ribavirin in Treatment-Naïve, Non-cirrhotic Patients With Chronic Genotype 1a Hepatitis-C for Eight, Six or Four Weeks
The purpose of this study is to determine whether treatment with
Daclatasvir/Asunaprevir/BMS-791325, with or without ribavirin, for 8, 6, or 4 weeks is
feasible for the treatment of genotype 1a chronic hepatitis C in patients without cirrhosis.
Daclatasvir/Asunaprevir/BMS-791325, with or without ribavirin, for 8, 6, or 4 weeks is
feasible for the treatment of genotype 1a chronic hepatitis C in patients without cirrhosis.
Inclusion Criteria:
- Subjects chronically infected with HCV genotype 1a
- HCV RNA ≥ 10,000 IU/mL at screening
- Treatment-naïve subjects with no previous exposure to an interferon formulation (ie,
IFNα, pegIFNα), ribavirin (RBV), or HCV direct acting antiviral (DAA; protease,
polymerase inhibitor, etc.)
Exclusion Criteria:
- Evidence of cirrhosis
- Liver or any other organ transplant
- Current or known history of cancer within 5 years prior to enrollment
- Documented or suspected hepatocellular carcinoma (HCC)
- Not eligible for sofosbuvir + pegylated interferon + ribavirin therapy
We found this trial at
1
site
Click here to add this to my saved trials
