A Study of Daclatasvir and Sofosbuvir With Ribavirin in Subjects With Cirrhosis and Genotype 3 Hepatitis C Infection

Completed · Phase 3

Conditions studied: Hepatitis C

In brief

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.

Key facts

Study ID

NCT02673489

Run by

Bristol-Myers Squibb

People needed

106

Starts

2016-03-15

Expected to finish

2017-05-26

Last updated by the study team

2018-05-08

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Keck Medical Center Of USC — Los Angeles, California, United States
• University Of California, San Francisco — San Francisco, California, United States
• Gastrointestinal Specialists of Georgia, PC — Marietta, Georgia, United States
• Ruth Rothstein Core Center — Chicago, Illinois, United States
• Digestive Disease Associates, PA — Catonsville, Maryland, United States
• Northeast Clinical Research Center — Bethlehem, Pennsylvania, United States
• University Gastroenterology — Providence, Rhode Island, United States
• Texas Clinical Research Institute — Arlington, Texas, United States
• Methodist Transplant Physicians — Dallas, Texas, United States
• The Texas Liver Institute — San Antonio, Texas, United States
• Inova Fairfax Hospital — Falls Church, Virginia, United States
• Bon Secours St. Mary's Hospital of Richmond, Inc — Richmond, Virginia, United States
• Local Institution — Calgary, Alberta, Canada
• Local Institution — Edmonton, Alberta, Canada
• Local Institution — Vancouver, British Columbia, Canada
• Local Institution — Victoria, British Columbia, Canada
• Local Institution — Toronto, Ontario, Canada
• Local Institution — Montreal, Quebec, Canada
• Local Institution — Regina, Saskatchewan, Canada

Full record on ClinicalTrials.gov

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