Trials / Completed
CompletedNCT02092350
Safety and Efficacy of Grazoprevir (MK-5172) + Elbasvir (MK-8742) in Participants With Chronic Hepatitis C and Chronic Kidney Disease (MK-5172-052)
A Phase II/III Randomized Clinical Trial to Study the Efficacy and Safety of the Combination Regimen of MK-5172 and MK-8742 in Subjects With Chronic Hepatitis C Virus Infection and Chronic Kidney Disease
- Status
- Completed
- Phase
- Phase 2 / Phase 3
- Study type
- Interventional
- Enrollment
- 237 (actual)
- Sponsor
- Merck Sharp & Dohme LLC · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
This study will evaluate the safety and efficacy of combination treatment with grazoprevir (MK-5172) + elbasvir (MK-8742) for cirrhotic and non-cirrhotic participants with chronic Genotype 1 (GT1) hepatitis C virus (HCV) infection and chronic kidney disease (CKD). The primary study hypothesis is that the proportion of HCV GT1-infected CKD participants within the Immediate Treatment and Intensive Pharmacokinetics (PK) groups achieving a sustained viral response 12 weeks after the end of all study treatment (SVR12) will be \>45%.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Grazoprevir | Grazoprevir 100 mg tablet |
| DRUG | Elbasvir | Elbasvir 50 mg tablet |
| DRUG | Placebo to Grazoprevir | Placebo tablet matched to grazoprevir |
| DRUG | Placebo to Elbasvir | Placebo tablet matched to elbasvir |
Timeline
- Start date
- 2014-03-17
- Primary completion
- 2015-03-11
- Completion
- 2015-09-02
- First posted
- 2014-03-20
- Last updated
- 2018-09-24
- Results posted
- 2016-04-12
Source: ClinicalTrials.gov record NCT02092350. Inclusion in this directory is not an endorsement.