Multi-Center, Randomized, Open-Label Study of G/P +/- RBV for NS5A + SOF Previously Treated GT1 HCV Subjects
a study on Hepatitis C
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.
A Phase 3b, Multi-Center, Randomized, Open-Label, Pragmatic Study of Glecaprevir/Pibrentasvir (G/P) +/- Ribavirin for GT1 Subjects With Chronic Hepatitis C Previously Treated With an NS5A Inhibitor + Sofosbuvir Therapy
The primary purpose of this study is to compare the efficacy and safety of glecaprevir and pibrentasvir (G/P) for 12 weeks to G/P for 16 weeks in non-cirrhotic NS5A (non-structural protein 5a)-inhibitor plus sofosbuvir ± RBV (Ribavirin) treatment-experienced adults with HCV genotype 1 (GT1) infection, and to compare the efficacy and safety of G/P with RBV for 12 weeks to G/P without RBV for 16 weeks in NS5A-inhibitor plus sofosbuvir (SOF) ± RBV treatment-experienced adults with compensated cirrhosis and GT1 infection.
Hepatitis C HCV Previously treated Ribavirin
You can join if…
Open to people ages 18–100
- 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 CAN'T join 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.
- University of California, San Francisco accepting new patients
San Francisco, California, 94143, United States
- Virginia Mason Medical Center accepting new patients
Seattle, Washington, 98101, United States
- University of Washington accepting new patients
Seattle, Washington, 98104, United States
- Integris Baptist Medical Center accepting new patients
Oklahoma City, Oklahoma, 73112, United States
- Univ. of Minnesota Health Clinics and Surgery Center, Inc. accepting new patients
Minneapolis, Minnesota, 55455, United States
- Rush University Medical Center accepting new patients
Chicago, Illinois, 60612, United States
- University of Michigan accepting new patients
Ann Arbor, Michigan, 48109-5601, United States
- Atlanta Medical Center accepting new patients
Atlanta, Georgia, 303012, United States
- Atlanta Gastro Associates accepting new patients
Atlanta, Georgia, 30308, United States
- UF Hepatology Research at CTRB accepting new patients
Gainesville, Florida, 32610, United States
- UF Health Jacksonville-Gastroenterology Emerson accepting new patients
Jacksonville, Florida, 32207, United States
- University of North Carolina at Chapel Hill accepting new patients
Chapel Hill, North Carolina, 27599, United States
- Medical University of South Carolina accepting new patients
Charleston, South Carolina, 29425, United States
- Orlando Immunology Center accepting new patients
Orlando, Florida, 32803, United States
- Bon Secours Liver Institute of Virginia accepting new patients
Richmond, Virginia, 23226, United States
- Virginia Commonwealth University accepting new patients
Richmond, Virginia, 23298-0341, United States
- Georgetown University Hospital accepting new patients
Washington, D.C., District of Columbia, 20007, United States
- MedStar Health Research Institute accepting new patients
Washington, D.C., District of Columbia, 20010, United States
- Digestive Disease Associates, PA accepting new patients
Catonsville, Maryland, 21228, United States
- The Johns Hopkins Hospital/John G. Bartlett Specialty Practice accepting new patients
Baltimore, Maryland, 21287, United States
- University of Pennsylvania-Perelman Center for Advanced Medicine accepting new patients
Philadelphia, Pennsylvania, 19104, United States
- Schiff Center for Liver Diseases/University of Miami accepting new patients
Miami, Florida, 33136, United States
- NYU Langone Medical Center accepting new patients
New York, New York, 10016, United States
- Northwell Health - Sandra Atlaas Bass Center for Liver Diseases accepting new patients
Manhasset, New York, 11030, United States
- Massachusetts General Hospital accepting new patients
Boston, Massachusetts, 02114, United States
Please contact me about this study
We will not share your information with anyone other than the team in charge of this study. Submitting your contact information does not obligate you to participate in research.
The study team should get back to you in a few business days.
You will also receive an email with next steps. Check your junk/spam folder if needed.
If you do not hear from the study team, please call 888-689-8273 and tell them you’re interested in study number NCT03092375.