Status:
COMPLETED
Grazoprevir (MK-5172) and Elbasvir (MK-8742) Combination for Chronic Hepatitis C Virus (HCV) Genotypes 1, 4, and 6 (MK-5172-065)
Lead Sponsor:
Merck Sharp & Dohme LLC
Conditions:
Hepatitis C
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
This is a randomized, multi-site, placebo-controlled trial of a fixed dose combination (FDC) of grazoprevir (MK-5172) 100 mg + elbasvir (MK-8742) 50 mg in participants with chronic Hepatitis C Virus (...
Eligibility Criteria
Inclusion
- has HCV GT1, GT4, or GT6 with sickle cell anemia, thalassemia, or hemophilia/von Willebrand disease
- has cirrhosis or is non-cirrhotic
- is human immunodeficiency virus (HIV) coinfected or not infected with HIV
- is a female of non childbearing potential, or is male or female and uses an acceptable method(s) of contraception
Exclusion
- has evidence of decompensated liver disease
- is coinfected with hepatitis B
- has had a malignancy ≤5 years prior to signing informed consent except for adequately treated basal cell or squamous cell skin cancer or in situ cervical cancer
- has hepatocellular carcinoma (HCC) or is under evaluation for HCC
- has clinically-relevant drug or alcohol abuse within 12 months of screening
Key Trial Info
Start Date :
October 22 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 14 2016
Estimated Enrollment :
159 Patients enrolled
Trial Details
Trial ID
NCT02252016
Start Date
October 22 2014
End Date
June 14 2016
Last Update
October 3 2018
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