Status:
COMPLETED
Grazoprevir (MK-5172) and Elbasvir (MK-8742) Combination in Treatment-Naïve Hepatitis C Virus Participants (MK-5172-067)
Lead Sponsor:
Merck Sharp & Dohme LLC
Conditions:
Hepatitis C
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
This is a randomized, parallel-group, placebo-controlled, multi-site, multinational, double-blind followed by open label period, Phase 3 trial of 100 mg of grazoprevir (MK-5172) in combination with 50...
Eligibility Criteria
Inclusion
- Has documented chronic HCV GT1, GT4, or GT6 (with no evidence of non-typeable or mixed genotype) infection
- Meets clinical criteria for presence or absence of cirrhosis based on liver disease staging assessment
- Is abstinent or uses acceptable method(s) of contraception
Exclusion
- Has evidence of decompensated liver disease
- Is coinfected with hepatitis B virus or human immunodeficiency virus (HIV)
- Shows evidence of hepatocellular carcinoma (HCC) or is under evaluation for HCC
- Has a clinically-relevant drug or alcohol abuse within 12 months of screening
- Is pregnant or breast-feeding
- Has any condition or abnormality that might confound the results of the trial or pose an additional risk to the participant
Key Trial Info
Start Date :
January 28 2015
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 10 2017
Estimated Enrollment :
489 Patients enrolled
Trial Details
Trial ID
NCT02251990
Start Date
January 28 2015
End Date
April 10 2017
Last Update
January 30 2019
Active Locations (0)
Enter a location and click search to find clinical trials sorted by distance.
No Results Found
We couldn’t find results for the location/zipcode entered or within the selected range. Please check your input or adjust your search.