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

• Status: Completed
• Trial end date: 2015-09-02
• Target enrollment: 0
• Participant gender: All

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%.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Merck Sharp & Dohme Corp.
• Treatments: Grazoprevir

Criteria

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