Open-Label, Randomized Study of Daclatasvir, Sofosbuvir, and Ribavirin for 12 vs. 16 Weeks in Treatment Naive and Treatment Experienced Patients With Genotype 3 Chronic Hepatitis C Infection Subjects With Compensated Advanced Fibrosis/Cirrhosis (F3/F4)
Overview
- Phase
- Phase 3
- Intervention
- Daclatasvir
- Conditions
- Hepatitis C
- Sponsor
- Bristol-Myers Squibb
- Enrollment
- 53
- Locations
- 1
- Primary Endpoint
- Percent of Participants With a Sustained Virologic Response (SVR) at Follow-up Week 12 (SVR12)
- Status
- Completed
- Last Updated
- 9 years ago
Overview
Brief Summary
The purpose of the study is to determine if the combination of Daclatasvir, Sofosbuvir and Ribavirin for 12 or 16 weeks is safe and effective in the treatment of Genotype 3 Chronic Hepatitis C (HCV) in patients with advanced fibrosis or compensated cirrhosis. Patients in this study may have already been treated prior for HCV or may have never received treatment for their HCV.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Must have Genotype 3 Chronic HCV
- •Must have advanced fibrosis (F3) or compensated cirrhosis (F4)
- •HCV RNA Viral load ≥ 10,000 IU/mL
- •HCV Treatment naive or treatment-experienced
Exclusion Criteria
- •Non Genotype 3 or mixed genotypes
- •Non advanced fibrosis or compensated cirrhosis
- •Any prior treatment with NS5A inhibitors
Arms & Interventions
Arm1: Daclatasvir + Sofosbuvir + Ribavirin (12 Weeks)
Oral dosing Daclatasvir 60mg once daily, Sofosbuvir 400mg once daily, and Ribavirin 1000-1200mg (weight based dosing) split into am and pm dosing
Intervention: Daclatasvir
Arm1: Daclatasvir + Sofosbuvir + Ribavirin (12 Weeks)
Oral dosing Daclatasvir 60mg once daily, Sofosbuvir 400mg once daily, and Ribavirin 1000-1200mg (weight based dosing) split into am and pm dosing
Intervention: Sofosbuvir
Arm1: Daclatasvir + Sofosbuvir + Ribavirin (12 Weeks)
Oral dosing Daclatasvir 60mg once daily, Sofosbuvir 400mg once daily, and Ribavirin 1000-1200mg (weight based dosing) split into am and pm dosing
Intervention: Ribavirin
Arm2 : Daclatasvir + Sofosbuvir + Ribavirin (16 Weeks)
Oral dosing Daclatasvir 60mg once daily, Sofosbuvir 400mg once daily, and Ribavirin 1000-1200mg (weight based dosing) split into am and pm dosing
Intervention: Daclatasvir
Arm2 : Daclatasvir + Sofosbuvir + Ribavirin (16 Weeks)
Oral dosing Daclatasvir 60mg once daily, Sofosbuvir 400mg once daily, and Ribavirin 1000-1200mg (weight based dosing) split into am and pm dosing
Intervention: Sofosbuvir
Arm2 : Daclatasvir + Sofosbuvir + Ribavirin (16 Weeks)
Oral dosing Daclatasvir 60mg once daily, Sofosbuvir 400mg once daily, and Ribavirin 1000-1200mg (weight based dosing) split into am and pm dosing
Intervention: Ribavirin
Outcomes
Primary Outcomes
Percent of Participants With a Sustained Virologic Response (SVR) at Follow-up Week 12 (SVR12)
Time Frame: Follow-up Week 12
SVR12, defined as percentage of participants with hepatitis C virus (HCV) ribonucleic acid (RNA) \< lower limit of quantitation (LLOQ), target detected (TD) or target not detected (TND) at follow-up Week 12. SVR12 imputation was based on Next Value Carried Backwards (NVCB) approach. HCV RNA measurements were excluded after the start of non-study anti-HCV medication on treatment or during follow-up.
Secondary Outcomes
- Number of Participants With Death, Serious Adverse Events (SAEs), Discontinuation Due to Adverse Events (AEs), Grade 3 or Grade 4 (Grade 3/4) AEs, and Grade 3/4 Laboratory Abnormalities(Date of First Dose of Study Drug to 7 Days post last dose of study drug (up to 13 weeks or 17 weeks depending on the randomized treatment group))
- Percent of Participants With a Sustained Virologic Response (SVR) at Follow-up Week 4 (SVR4) and Follow-up Week 24 (SVR24)(Follow-up Weeks 4 and 24)