Clareo Health | Safety and Efficacy of Grazoprevir (MK-5172) + Elbasvir (MK-8742) in Participants With Chronic Hepatitis C and Chronic Kidney Disease (MK-5172-052)
Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Merck Sharp & Dohme LLC
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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
You may not be if
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
