A Randomized, Open-Label Study of Daclatasvir and Sofosbuvir With or Without Ribavirin for 8 Weeks in Treatment-Naïve, Non-cirrhotic Subjects Infected With Chronic Hepatitis C Virus (HCV) Genotype 3
- Registration Number
- NCT02551861
- Lead Sponsor
- Bristol-Myers Squibb
- Brief Summary
The purpose of this study is to determine if 8 weeks of Daclatasvir plus Sofosbuvir with or without Ribavirin is safe and effective in the treatment of genotype 3 hepatitis C infected patients without advanced fibrosis or liver cirrhosis who have never been treated previously.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- All
- Target Recruitment
- Not specified
Inclusion Criteria
- Genotype 3
- HCV RNA < 2000000 IU/mL
- Never taken HCV medication
- Absence of advanced fibrosis or cirrhosis
- Body mass index (BMI) 18-40 kg/m^2
Exclusion Criteria
- Infection with HCV other than genotype 3 (GT3); Mixed infections of any genotype
- Previously taken HCV medication
- Liver Cirrhosis
- Evidence of decompensated liver disease
- HIV/ hepatitis B virus (HBV) coinfection
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Daclatasvir + Sofosbuvir + Ribavirin Sofosbuvir Daclatasvir 60mg tablet + Sofosbuvir 400mg tablet+ Ribavirin 1000-1200mg tablet(weight based dosing) oral dosing split into am and pm once daily for 8 weeks Daclatasvir + Sofosbuvir Sofosbuvir Daclatasvir 60mg tablet and Sofosbuvir 400mg tablet oral dosing once daily for 8 weeks Daclatasvir + Sofosbuvir + Ribavirin Ribavirin Daclatasvir 60mg tablet + Sofosbuvir 400mg tablet+ Ribavirin 1000-1200mg tablet(weight based dosing) oral dosing split into am and pm once daily for 8 weeks Daclatasvir + Sofosbuvir Daclatasvir Daclatasvir 60mg tablet and Sofosbuvir 400mg tablet oral dosing once daily for 8 weeks Daclatasvir + Sofosbuvir + Ribavirin Daclatasvir Daclatasvir 60mg tablet + Sofosbuvir 400mg tablet+ Ribavirin 1000-1200mg tablet(weight based dosing) oral dosing split into am and pm once daily for 8 weeks
- Primary Outcome Measures
Name Time Method Proportion of subjects with sustained virologic response (SVR12) treated with Daclatasvir + Sofosbuvir (DCV+SOF) Post Treatment Follow up Week 12 SVR12 defined as HCV RNA \< LLOQ target detected (TD) or target not detected (TND) at follow-up Week 12 in subjects treated with 8 weeks of DCV+SOF therapy or DCV+SOF+RBV therapy
- Secondary Outcome Measures
Name Time Method Safety measured by number of incidence of deaths, serious adverse events (SAE)s, discontinuation due to adverse events (AE)s, Grade 3/4 AEs and Grade 3/4 laboratory abnormalities observed from clinical laboratory testing Approximately 1.5 years Antiviral activity measured by the proportion of subjects who achieve HCV RNA < lower limit of quantification (LLOQ) - at during and after treatment in each treatment arm Post treatment follow up Week 24 Proportion of subjects with CC, CT or TT IL28B genotype who achieve SVR12 in each treatment arm Post Treatment Follow up Week 12
Trial Locations
- Locations (1)
Local Institution
🇫🇷Vandoeuvre Les Nancy, France
Local Institution🇫🇷Vandoeuvre Les Nancy, France