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)
Status and phase
Completed
Phase 3
Phase 2
Conditions
Hepatitis C Virus
Treatments
Drug: Placebo to Elbasvir
Drug: Grazoprevir
Drug: Elbasvir
Drug: Placebo to Grazoprevir
Study type
Interventional
Funder types
Industry
Identifiers
Details and patient eligibility
About
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%.
Enrollment
237 patients
Sex
All
Ages
18+ years old
Volunteers
No Healthy Volunteers
Inclusion criteria
- Documented chronic (at least 6 months) HCV GT 1 infection (with no evidence of mixed genotypes or genotype that cannot be assigned a type)
- Evidence or no evidence of liver cirrhosis based on one of the following:
- Liver biopsy performed within 24 months of Day 1 (if participant is cirrhotic then there is no time restriction on biopsy)
- Fibroscan performed within 12 months of Day 1 of this study
- Fibrosure™ (Fibrotest™) plus aspartate aminotransferase to platelet Ratio Index [APRI] obtained during the screening period)
- Has HCV status that is one of the following:
- Treatment naïve
- Prior interferon or pegylated interferon with or without ribavarin failures (null responder, partial responder, or relapser)
- Intolerant to prior interferon or pegylated intereferon with or without ribavarin regimen
- Chronic kidney disease (defined as glomerular filtration rate [eGFR] <=29) non-dialysis dependent or on hemodialysis for at least 3 months, including individuals awaiting kidney transplant and those with failed kidney transplants but no longer on immunosuppressant therapy)
- Female participant of reproductive potential must agree to remain abstinent or use (or have their partner use) 2 acceptable methods of contraception from at least 2 weeks prior to Day 1 through 14 days after the last dose of study drugs, or longer if dictated by local regulations
Exclusion criteria
- Evidence of decompensated liver disease
- On peritoneal dialysis for management of kidney disease
- Co-infection with hepatitis B virus or human immunodeficiency virus (HIV)
- History of malignancy <=5 years prior to signing informed consent
- Clinical diagnosis of substance abuse
- Pregnant, breast-feeding, expecting to conceive or donate eggs, or donate sperm from Day 1 through 14 days after the last study dose, or longer if dictated by local regulations
- Organ transplant (including hematopoietic stem cell transplant) other than kidney, cornea, and hair
- Conditions requiring, or likely to require, chronic systemic administration of corticosteroids during the course of the trial
- Uncontrolled or poorly controlled hypertension
- Significant cardiovascular disorder (e.g. myocardial infarction or unstable angina) or cardiovascular procedure within 3 months prior to signing informed consent
- New or worsening signs or symptoms of congestive heart failure within 3 months of signing informed consent
- Severe active peripheral vascular disease
- Recent (within 3 months prior to signing informed consent) episode or recurrence of stroke, transient ischemic attack (TIA) or neurological disorder, including but not limited to seizures
- Evidence or history of chronic hepatitis not caused by HCV
Trial design
Primary purpose
Treatment
Allocation
Randomized
Interventional model
Parallel Assignment
Masking
Double Blind
237 participants in 3 patient groups
Immediate Treatment
Experimental group
Description:
Participants receive grazoprevir 100 mg tablet, orally, once per day (QD) + elbasvir 50 mg tablet, orally, QD, for 12 weeks.
Treatment:
Drug: Elbasvir
Drug: Grazoprevir
Deferred Treatment
Experimental group
Description:
Participants receive placebos to both grazoprevir and elbasvir for 12 weeks, and after a 4-week break, grazoprevir 100 mg tablet, orally, QD + elbasvir 50 mg tablet, orally, QD for 12 weeks.
Treatment:
Drug: Elbasvir
Drug: Grazoprevir
Drug: Placebo to Elbasvir
Drug: Placebo to Grazoprevir
Intensive PK
Experimental group
Description:
Participants receive grazoprevir 100 mg tablet, orally, QD + elbasvir 50 mg tablet, orally, QD for 12 weeks with intensive PK testing.
Treatment:
Drug: Elbasvir
Drug: Grazoprevir
Trial contacts and locations
0
Loading...
Data sourced from clinicaltrials.gov
Clinical trials
Research sites
Resources
Legal
© Copyright 2025 Veeva Systems