Safety and Efficacy of Grazoprevir (MK-5172) + Elbasvir (MK-8742) in Participants With Chronic Hepatitis C and Chronic Kidney Disease (MK-5172-052) (C-SURFER)

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). After a screening period, participants will receive random assignment to one of two study arms (immediate treatment or deferred treatment), or assignment to open-label immediate treatment with intensive pharmacokinetic sampling. The primary study hypothesis is that the proportion of participants achieving a sustained viral response 12 weeks after the end of all study treatment (SVR12) will be >45%.


Study Type: Interventional
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: 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
Enrollment: 237
Study Start Date: March 2014
Study Completion Date: September 2015
Primary Completion Date: March 2015 (Final data collection date for primary outcome measure)

Arms:
- Experimental: Immediate Treatment
- Experimental: Deferred Treatment
- Experimental: Immediate Treatment/PK Testing