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Eligibility
for people ages 18 years and up
Location
at San Francisco, California and other locations
Dates
study started
estimated completion:

Description

Summary

The purpose of this study is to determine whether 24 weeks of Daclatasvir and Sofosbuvir with Ribavirin is safe and effective in the treatment of genotype 3 hepatitis C infected patients with liver cirrhosis.

Official Title

A Phase 3 Evaluation of Daclatasvir and Sofosbuvir With Ribavirin in Cirrhotic Subjects With Genotype 3 Chronic Hepatitis C Infection

Keywords

Hepatitis C Ribavirin Sofosbuvir

Eligibility

For people ages 18 years and up

For more information regarding Bristol-Myers Squibb (BMS) Clinical Trial participation,please visit www.BMSStudyConnect.com

Inclusion Criteria:

  • Genotype 3 HCV
  • HCV RNA ≥10000 IU (International Unit)/mL
  • Compensated Liver Cirrhosis
  • BMI 18-40 kg/m2
  • Previously treated for HCV or never treated for HCV

Exclusion Criteria:

  • Infection with HCV other than Genotype 3. Mixed infection of any genotype
  • Evidence of decompensated liver disease
  • Previous exposure to NS5A inhibitors

    Other protocol defined inclusion/exclusion criteria could apply

Locations

  • University Of Southern California
    Los Angeles, California, 90033, USA

Details

Status
in progress, not accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Bristol-Myers Squibb
Links
BMS Clinical Trial Information
BMS clinical trial educational resource
Investigator Inquiry form
FDA Safety Alerts and Recalls
ID
NCT02673489
Phase
Phase 3
Study Type
Interventional
Last Updated
February 2016