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Clinical trial

Safety and Efficacy Study of Daclatasvir 60mg, Sofosbuvir 400mg, and Ribavirin (Dosed Based Upon Weight) in Subjects With Chronic Genotype 3 Hepatitis C Infection With or Without Prior Treatment Experience and Compensated Advanced Cirrhosis for 12 or 16 W

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Last updated:1st Feb 2015

The purpose of this study is to determine if the use of Daclatasvir, Sofosbuvir, and Ribavirin in combination is safe and effective in the treatment of Genotype 3 Chronic Hepatitis C (HCV) in patients with compensated cirrhosis. Patients in this study may have already been treated prior for HCV or may have never received treatment for their HCV.


Study Type: Interventional
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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)
Estimated Enrollment: 50
Study Start Date: February 2015
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)

Arms:
- Active Comparator:
Arm1: Daclatasvir + Sofosbuvir + Ribavirin (12 Weeks)
- Active Comparator: Arm2 : Daclatasvir + Sofosbuvir + Ribavirin (16 Weeks)

Category Value
Study start date 2015-02-01

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