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COMPLETEDPHASE2

Elbasvir/Grazoprevir (EBR/GZR) and Sofosbuvir (SOF) With and Without Ribavirin (RBV) in Cirrhotic Subjects With Chronic Hepatitis C Virus (HCV) Genotype 3 (GT3) Infection (MK-5172-083)

A Phase II, Randomized, Open-Label Clinical Trial to Study the Efficacy and Safety of the Combination Regimen of Elbasvir/Grazoprevir (EBR/GZR) and Sofosbuvir (SOF) With and Without Ribavirin (RBV) in Cirrhotic Subjects With Chronic HCV GT3 Infection

NCT02601573•Merck Sharp & Dohme LLC

View on ClinicalTrials.gov

Summary

This is a randomized, multi-site, open-label trial of the co-administration of a fixed-dose combination (FDC) of EBR 50 mg + GZR (100 mg) (EBR/GZR) and SOF 400 mg, with and without RBV, in treatment-naïve (TN) and treatment-experienced (TE) participants with chronic HCV GT3 infection with compensated cirrhosis.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•has HCV RNA (\>= 10,000 IU/mL in peripheral blood) at screening
•has documented HCV GT3 (with no evidence of non-typeable or mixed GT infection)
•has compensated cirrhosis of the liver
•has liver imaging within 6 months of Day 1 with no evidence of hepatocellular carcinoma (HCC)
•is either HCV TN or TE (i.e., has documented prior virologic failure or intolerance to peg-interferon/ribavirin)
•is otherwise healthy as determined by medical history, physical examination, electrocardiogram (ECG), and clinical laboratory measurements
•has compensated cirrhosis of the liver
•is TN or TE (i.e., documented prior virologic failure or intolerance to peg-interferon/ribavirin)
•is not of reproductive potential, or agrees to not impregnate a partner or become pregnant for at least 2 weeks prior to the first dose of study drug, and for 7 months after the final dose of study drug (or longer if dictated by local regulations)

Exclusion Criteria

•has previously received one or more doses of a direct-acting antiviral (DAA)
•has evidence of decompensated liver disease
•is coinfected with hepatitis B (hepatitis B surface antigen \[HBsAg\] positive)
•has a recent (within 5 years) history of malignancy or is under evaluation for HCC or other suspected malignancy
•is currently or has participated (within past 30 days) in a study with an investigational compound
•has clinically-relevant drug or alcohol abuse within the past 12 months of screening
•is a female and is pregnant or breast-feeding
•is a male whose female partner is/are pregnant
•has any of the following:
•organ transplants
+11 more criteria

Key Dates

Start Date

January 5, 2016

Primary Completion Date

October 18, 2016

Completion Date

January 6, 2017

Last Updated

August 13, 2019

Enrollment

101

ACTUAL participants

Conditions

Hepatitis C

Interventions

Grazoprevir

DRUG

Elbasvir

DRUG

Ribavirin

DRUG

Sofosbuvir

DRUG

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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: August 13, 2019Data 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

Elbasvir/Grazoprevir (EBR/GZR) and Sofosbuvir (SOF) With and Without Ribavirin (RBV) in Cirrhotic Subjects With Chronic Hepatitis C Virus (HCV) Genotype 3 (GT3) Infection (MK-5172-083)

Inclusion Criteria

Exclusion Criteria

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