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Efficacy and Safety of Elbasvir (MK-8742) + Grazoprevir (MK-5172) in Treatment-Naïve/Treatment-Experienced (TN/TE) French Participants With Hepatitis C Virus (HCV) Genotype 4 (GT4) Infection (MK-5172-096) | Clinical Trials | Clareo Health

COMPLETEDPHASE4

Efficacy and Safety of Elbasvir (MK-8742) + Grazoprevir (MK-5172) in Treatment-Naïve/Treatment-Experienced (TN/TE) French Participants With Hepatitis C Virus (HCV) Genotype 4 (GT4) Infection (MK-5172-096)

A Multi-Site, Open-Label, Partially-Randomized Trial of the Efficacy and Safety of Fixed Dose Elbasvir/Grazoprevir (EBR/GZR) Based Regimens in French Subjects With Chronic Hepatitis C Virus (HCV) Genotype 4 Infection

NCT03111108•Merck Sharp & Dohme LLC

View on ClinicalTrials.gov

Summary

The purpose of this study was to evaluate the efficacy of 8 and 12 weeks of treatment with a fixed dose combination (FDC) of elbasvir (EBR) 50 mg + grazoprevir (GZR) 100 mg (i.e., MK-5172A) as assessed by the percentage of participants with hepatitis C virus (HCV) genotype (GT) 4 infection that achieve sustained virologic response (HCV ribonucleic acid \[RNA\] \< Lower Limit of Quantification \[LLOQ\]) 12 weeks after the end of study therapy (SVR12). This study also evaluated the safety and tolerability of EBR/GZR.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Be a current resident of France
•Have HCV RNA (≥ 10,000 IU/mL in peripheral blood) at the time of screening
•Have documented chronic HCV GT4 (with no evidence of non-typeable or mixed genotype) infection
•Have liver biopsy performed within 24 months of Day 1 of this study (if participant has cirrhosis, there is no time restriction on biopsy), or have FibroScan® performed within 12 months of Day 1 of this study with interpretable result in kilopascals (kPa) as follows: Fibrosis score of F0-F2, Fibrosis score of F3, or Cirrhosis (F4)
•Have a prior treatment history of either HCV TN or HCV TE with interferon (IFN) +/- ribavirin (RBV) +/- Sofosbuvir (SOF) (on-treatment failure, relapser, or other/intolerant)
•Females who are of reproductive potential must agree to avoid becoming pregnant while receiving study drug and for 14 days after the last dose of study drug by complying with one of the following: (1) practice abstinence from heterosexual activity OR (2) use (or have her partner use) acceptable contraception during heterosexual activity
•If Human Immunodeficiency Virus (HIV) co-infected, then have HIV-1 infection documented prior to screening

Exclusion Criteria

•Had prior treatment (defined as 1 dose or more) with direct-acting antiviral (DAA) therapy
•Has evidence of decompensated liver disease manifested by the presence of or history of ascites, esophageal or gastric variceal bleeding, hepatic encephalopathy, or other signs or symptoms of active advanced liver disease
•Classified as Child-Pugh B or C or has a Child Pugh-Turcotte score (CPT) \> 6
•Has cirrhosis and liver imaging within 6 months of Day 1 showing evidence of hepatocellular carcinoma (HCC) or is under evaluation for HCC
•Hepatitis B virus surface antigen (HBsAg) positive at screening. Participants who are HBsAg negative and hepatitis B core antibody (anti-HBc) positive at screening may be included
•Under evaluation for active or suspected malignancy, except for adequately treated basal cell or squamous cell skin cancer or in situ cervical cancer Currently participating or has participated in a study with an investigational compound within 30 days of signing informed consent and is not willing to refrain from participating in another such study during the course of this study

Locations (13)

CHU Amiens-Picardie - Hopital Sud ( Site 0217)

Amiens, France

CHU Jean Minjoz ( Site 0213)

Besançon, France

CHU Henri Mondor ( Site 0206)

Créteil, France

CHU de Grenoble - Hopital Michallon ( Site 0208)

Genoble, France

CHU Dupuytren ( Site 0209)

Limoges, France

Hopital Saint Eloi ( Site 0207)

Montpellier, France

C.H.U. de Nice Hopital de l Archet 2 ( Site 0215)

Nice, France

Centre Hospitalier Regional du Orleans ( Site 0212)

Orléans, France

Hopital Beaujon ( Site 0201)

Paris, France

Hopital Cochin ( Site 0211)

Paris, France

Key Dates

Start Date

June 20, 2017

Primary Completion Date

October 15, 2018

Completion Date

October 15, 2018

Last Updated

June 9, 2020

Enrollment

117

ACTUAL participants

Conditions

Hepatitis C Virus (HCV) Infection

Interventions

EBR/GZR (50 mg/100 mg) FDC

DRUG

A Study to Evaluate Long-term Outcomes Following Treatment With ABT-450/Ritonavir/ABT-267 (ABT-450/r/ABT-267) and ABT-333 With or Without Ribavirin (RBV) in Adults With Genotype 1 Chronic Hepatitis C Virus (HCV) Infection

NCT02219490

Chronic Hepatitis C Virus (HCV) Infection Genotype 1

View study

COMPLETEDPHASE3

A Study to Evaluate Long-term Outcomes Following Treatment With ABT-450/Ritonavir/ABT-267 (ABT-450/r/ABT-267) and ABT-333 With or Without Ribavirin (RBV) in Adults With Genotype 1 Chronic Hepatitis C Virus (HCV) Infection

NCT02167945

Chronic Hepatitis C Virus (HCV) Infection Genotype 1

View study

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: June 9, 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.

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