Multi-Center, Randomized, Open-Label Study of G/P +/- RBV for NS5A + SOF Previously Treated GT1 HCV Subjects

Completed · Phase 3

Conditions studied: Hepatitis C, HCV

In brief

The study will enroll well-compensated cirrhotic as well as non-cirrhotic subjects treatment experienced with an NS5a Inhibitor + sofosbuvir and will include patients who did not complete the prescribed duration due to adverse event or any reason other than for non/poor compliance. Subjects will be randomized to 12 or 16 weeks of treatment.

Key facts

Study ID

NCT03092375

Run by

University of Florida

People needed

177

Starts

2017-04-20

Expected to finish

2020-02-06

Last updated by the study team

2020-02-26

Who can join

Age: 18 and older, up to 100. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Male or female at least 18 years of age at time of screening.
• A history of previous treatment with an NS5A-inhibitor plus sofosbuvir therapy ± RBV for chronic HCV genotype 1 infection.
• Treatment must have been completed at least 1 month prior to Screening Visit.
• Screening laboratory result indicating chronic HCV GT1 infection. Subjects must be able to understand and adhere to the study visit schedule and all other protocol requirements and must voluntarily sign and date an informed consent.

You may not qualify if…

• History of severe, life-threatening or other significant sensitivity to any drug.
• Female who is pregnant, planning to become pregnant during the study or breastfeeding; or male whose partner is pregnant or planning to become pregnant during the study.
• Recent (within 6 months prior to study drug administration) history of drug or alcohol abuse that could preclude adherence to the protocol in the opinion of the investigator.
• Positive test result at Screening for hepatitis B surface antigen (HBsAg) or anti-human immunodeficiency virus antibody (HIV Ab) in patient without known history of HIV infection.
• HCV genotype performed during screening indicating co-infection with more than one HCV genotype.
• History or presence of liver decompensation.

Where it is running

• Stanford University — Palo Alto, California, United States
• University of California, San Francisco — San Francisco, California, United States
• Georgetown University Hospital — Washington D.C., District of Columbia, United States
• MedStar Health Research Institute — Washington D.C., District of Columbia, United States
• UF Hepatology Research at CTRB — Gainesville, Florida, United States
• UF Health Jacksonville-Gastroenterology Emerson — Jacksonville, Florida, United States
• Schiff Center for Liver Diseases/University of Miami — Miami, Florida, United States
• Orlando Immunology Center — Orlando, Florida, United States
• Atlanta Medical Center — Atlanta, Georgia, United States
• Atlanta Gastro Associates — Atlanta, Georgia, United States
• Rush University Medical Center — Chicago, Illinois, United States
• The Johns Hopkins Hospital/John G. Bartlett Specialty Practice — Baltimore, Maryland, United States
• Digestive Disease Associates, PA — Catonsville, Maryland, United States
• Massachusetts General Hospital — Boston, Massachusetts, United States
• University of Michigan — Ann Arbor, Michigan, United States
• Univ. of Minnesota Health Clinics and Surgery Center, Inc. — Minneapolis, Minnesota, United States
• Southern Therapy and Advanced Research — Jackson, Mississippi, United States
• Northwell Health - Sandra Atlaas Bass Center for Liver Diseases — Manhasset, New York, United States
• NYU Langone Medical Center — New York, New York, United States
• Weill Cornell Medicine, Hepatology — New York, New York, United States
• Columbia University Medical Center — New York, New York, United States
• University of North Carolina at Chapel Hill — Chapel Hill, North Carolina, United States
• Duke University Medical Center — Durham, North Carolina, United States
• The Ohio State University — Columbus, Ohio, United States
• Integris Baptist Medical Center — Oklahoma City, Oklahoma, United States

Full record on ClinicalTrials.gov

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