Trials / Withdrawn
WithdrawnNCT03143998
Efficacy and Safety of Elbasvir/Grazoprevir in Brazilian Participants With Chronic Hepatitis C Virus (HCV) Genotype 1 Infection With Advanced Fibrosis (F3 and F4)
A Multi-Site, Open-Label, Trial of the Efficacy and Safety of Fixed-dose Elbasvir/Grazoprevir (EBR/GZR) in Brazilian Patients With Chronic Hepatitis C Virus (HCV) Genotype 1 Infection With Advanced Fibrosis (F3 and F4)
- Status
- Withdrawn
- Phase
- Phase 4
- Study type
- Interventional
- Enrollment
- 0 (actual)
- Sponsor
- Merck Sharp & Dohme LLC · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
This is a non-randomized, open-label study of a fixed dose combination (FDC) of elbasvir (50 mg) and grazoprevir (100 mg) (EBR/GZR or MK-5172A) in participants with chronic hepatitis C virus (HCV) genotype 1 (GT1) infection with advanced fibrosis with and without human immunodeficiency virus (HIV) co-infection. All participants will be either HCV treatment naïve (TN) or treatment experienced (TE).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | MK-5172A | A single FDC tablet containing grazoprevir 100 mg + elbasvir 50 mg taken once daily by mouth. |
Timeline
- Start date
- 2018-02-12
- Primary completion
- 2019-01-12
- Completion
- 2019-01-12
- First posted
- 2017-05-08
- Last updated
- 2017-11-09
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03143998. Inclusion in this directory is not an endorsement.