Skip to main content

Summary

for people ages 18–100 (full criteria)
at San Francisco, California and other locations
study started
estimated completion:

Description

Summary

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.

Official Title

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

Details

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.

Keywords

Hepatitis C HCV Previously treated Hepatitis Ribavirin

Eligibility

You can join if…

Open to people ages 18–100

  1. Male or female at least 18 years of age at time of screening.
  2. A history of previous treatment with an NS5A-inhibitor plus sofosbuvir therapy ± RBV for chronic HCV genotype 1 infection.
  3. Treatment must have been completed at least 1 month prior to Screening Visit.
  4. 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...

  1. History of severe, life-threatening or other significant sensitivity to any drug.
  2. 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.
  3. 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.
  4. 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.
  5. HCV genotype performed during screening indicating co-infection with more than one HCV genotype.
  6. History or presence of liver decompensation.

Locations

  • University of California, San Francisco accepting new patients
    San Francisco, California, 94143, United States
  • Stanford University accepting new patients
    Palo Alto, California, 94305, United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
University of Florida
ID
NCT03092375
Phase
Phase 3
Lead Scientist
Norah Terrault
Study Type
Interventional
Last Updated
August 24, 2017
I’m interested in this study!