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

COMPLETEDPHASE3

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

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

NCT03092375•University of Florida

View on ClinicalTrials.gov

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.

Detailed Description

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.

Eligibility

Age

18 - 100 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•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.

Exclusion Criteria

•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 (31)

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

Key Dates

Start Date

April 20, 2017

Primary Completion Date

December 28, 2018

Completion Date

February 6, 2020

Last Updated

February 26, 2020

Enrollment

177

ACTUAL participants

Conditions

Hepatitis CHCV

Interventions

Glecaprevir/Pibrentasvir (G/P) 300mg/120mg

DRUG

Ribavirin 200Mg Tablet

DRUG

Implementing Low-Barrier HCV Treatment in a Jail Setting

NCT06953479

HEPATITIS C (HCV)Incarceration+2 more

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RECRUITINGNA

Prophylaxis With Direct-acting Antivirals for Kidney Transplantation From HCV-Infected Donors to Uninfected Recipients

NCT05653232

HCV

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 26, 2020Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

Implementing Low-Barrier HCV Treatment in a Jail Setting

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