Overview

Study to Evaluate the Safety and Efficacy of Daclatasvir/Sofosbuvir/Ribavirin for 16 Versus 24 Weeks for HCV Genotype 3 Cirrhotics

Status:
Completed

Trial end date:
2017-08-01

Target enrollment:

Participant gender:

Summary

This is a randomized, open label, single center safety and efficacy study. At least 40 cirrhotic subjects with HCV genotype 3 will receive standard of care treatment of sofosbuvir and ribavirin (SOF/RBV) as well as 60 mg daily of Daclatasvir (investigational product). Subjects will be randomized in a 1:1 to receive either: - Group A: 16 weeks of DCV/SOF/RBV - Group B: 24 weeks of DCV/SOF/RBV Subjects will return to the study center at various time points throughout the 16 or 24 weeks of treatment in addition to 12 weeks post taking last dose of study drug to monitor safety and efficacy. These visits will be according to standard of care.

Phase:

Phase 4

Details

Lead Sponsor:

Tarek I. Hassanein, M.D., FACP, FAG, AGAF

Treatments:

Ribavirin
Sofosbuvir