Phase
Condition
Hepatitis
Hiv
Liver Disorders
Treatment
N/AClinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Documented chronic (at least 6 months) HCV GT 1 infection (with no evidence of mixedgenotypes 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 thenthere 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 (nullresponder, partial responder, or relapser)
Intolerant to prior interferon or pegylated intereferon with or without ribavarinregimen
Chronic kidney disease (defined as glomerular filtration rate [eGFR] <=29)non-dialysis dependent or on hemodialysis for at least 3 months, including individualsawaiting kidney transplant and those with failed kidney transplants but no longer onimmunosuppressant therapy)
Female participant of reproductive potential must agree to remain abstinent or use (orhave their partner use) 2 acceptable methods of contraception from at least 2 weeksprior to Day 1 through 14 days after the last dose of study drugs, or longer ifdictated by local regulations
Exclusion
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 fromDay 1 through 14 days after the last study dose, or longer if dictated by localregulations
Organ transplant (including hematopoietic stem cell transplant) other than kidney,cornea, and hair
Conditions requiring, or likely to require, chronic systemic administration ofcorticosteroids during the course of the trial
Uncontrolled or poorly controlled hypertension
Significant cardiovascular disorder (e.g. myocardial infarction or unstable angina) orcardiovascular procedure within 3 months prior to signing informed consent
New or worsening signs or symptoms of congestive heart failure within 3 months ofsigning informed consent
Severe active peripheral vascular disease
Recent (within 3 months prior to signing informed consent) episode or recurrence ofstroke, transient ischemic attack (TIA) or neurological disorder, including but notlimited to seizures
Evidence or history of chronic hepatitis not caused by HCV
Study Design
Connect with a study center
Merck Sharp & Dohme (Argentina) Inc.
Buenos Aires,
ArgentinaSite Not Available
Merck Sharp & Dohme
North Ryde,
AustraliaSite Not Available
Merck Canada
Kirkland, Quebec H9H 3L1
CanadaSite Not Available
Merck Sharp & Dohme OU
Tallinn,
EstoniaSite Not Available
MSD France
Paris,
FranceSite Not Available
Merck Sharp & Dohme Co. Ltd.
Hod Hasharon,
IsraelSite Not Available
MSD Korea LTD
Seoul,
Korea, Republic ofSite Not Available
UAB "Merck Sharp & Dohme"
Vilnius,
LithuaniaSite Not Available
Merck Sharp & Dohme BV
Haarlem,
NetherlandsSite Not Available
Merck Sharp and Dohme de Espana S.A.
Madrid,
SpainSite Not Available
MSD
Sollentuna,
SwedenSite Not Available
Call for Information (Investigational Site 0608)
Phoenix, Arizona 85054
United StatesSite Not Available
Call for Information (Investigational Site 0563)
Tucson, Arizona 85724-5136
United StatesSite Not Available
Call for Information (Investigational Site 0573)
Coronado, California 92118
United StatesSite Not Available
Call for Information (Investigational Site 0599)
Sacramento, California 95817
United StatesSite Not Available
Call for Information (Investigational Site 0566)
San Diego, California 92114
United StatesSite Not Available
Call for Information (Investigational Site 0603)
New Haven, Connecticut 06520
United StatesSite Not Available
Call for Information (Investigational Site 0620)
Gainesville, Florida 32610
United StatesSite Not Available
Call for Information (Investigational Site 0567)
Jacksonville, Florida 32207
United StatesSite Not Available
Call for Information (Investigational Site 0586)
Miami, Florida 33136
United StatesSite Not Available
Call for Information (Investigational Site 0571)
Atlanta, Georgia 30308
United StatesSite Not Available
Call for Information (Investigational Site 0604)
Marietta, Georgia 30060
United StatesSite Not Available
Call for Information (Investigational Site 0570)
Chicago, Illinois 60611
United StatesSite Not Available
Call for Information (Investigational Site 0578)
Indianapolis, Indiana 46202
United StatesSite Not Available
Call for Information (Investigational Site 0617)
Iowa City, Iowa 52246
United StatesSite Not Available
Call for Information (Investigational Site 0562)
New Orleans, Louisiana 70112
United StatesSite Not Available
Call for Information (Investigational Site 0622)
Lutherville, Maryland 21093
United StatesSite Not Available
Call for Information (Investigational Site 0582)
Boston, Massachusetts 02111
United StatesSite Not Available
Call for Information (Investigational Site 0572)
Detroit, Michigan 48202
United StatesSite Not Available
Call for Information (Investigational Site 0561)
Saint Louis, Missouri 63104
United StatesSite Not Available
Call for Information (Investigational Site 0576)
St. Louis, Missouri 63110
United StatesSite Not Available
Call for Information (Investigational Site 0624)
New York, New York 10029
United StatesSite Not Available
Call for Information (Investigational Site 0584)
Rochester, New York 14642
United StatesSite Not Available
Call for Information (Investigational Site 0569)
Chapel Hill, North Carolina 27514
United StatesSite Not Available
Call for Information (Investigational Site 0615)
Charlotte, North Carolina 28204
United StatesSite Not Available
Call for Information (Investigational Site 0605)
Cincinnati, Ohio 45267
United StatesSite Not Available
Call for Information (Investigational Site 0592)
Cleveland, Ohio 44106-0139
United StatesSite Not Available
Call for Information (Investigational Site 0613)
Allentown, Pennsylvania 18102
United StatesSite Not Available
Call for Information (Investigational Site 0598)
Hershey, Pennsylvania 17033
United StatesSite Not Available
Call for Information (Investigational Site 0596)
Philadelphia, Pennsylvania 19104
United StatesSite Not Available
Call for Information (Investigational Site 0594)
Pittsburgh, Pennsylvania 15213
United StatesSite Not Available
Call for Information (Investigational Site 0590)
Clarksville, Tennessee 37043
United StatesSite Not Available
Call for Information (Investigational Site 0589)
Dallas, Texas 75246
United StatesSite Not Available
Call for Information (Investigational Site 0587)
Fort Worth, Texas 76104
United StatesSite Not Available
Call for Information (Investigational Site 0588)
Houston, Texas 77030
United StatesSite Not Available
Call for Information (Investigational Site 0579)
San Antonio, Texas 78215
United StatesSite Not Available
Call for Information (Investigational Site 0565)
Murray, Utah 84107
United StatesSite Not Available
Call for Information (Investigational Site 0601)
Norfolk, Virginia 23502
United StatesSite Not Available
Call for Information (Investigational Site 0583)
Richmond, Virginia 23249
United StatesSite Not Available
Call for Information (Investigational Site 0577)
Seattle, Washington 98101
United StatesSite Not Available
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