NCT03111108

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 117 (actual)
• Sponsor: Merck Sharp & Dohme LLC · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Hepatitis C Virus (HCV) Infection

Interventions

Type	Name	Description
DRUG	EBR/GZR (50 mg/100 mg) FDC	One FDC tablet taken once daily by mouth for 8 or 12 weeks depending upon randomization.

Timeline

• Start date: 2017-06-20
• Primary completion: 2018-10-15
• Completion: 2018-10-15
• First posted: 2017-04-12
• Last updated: 2020-06-09
• Results posted: 2019-11-12

Locations

13 sites across 1 country: France