EUCTR2014-000343-32-NL
Active, not recruiting
Phase 1
A Phase III Randomized Clinical Trial to Study the Efficacy and Safety of the Combination Regimen of MK-5172/MK-8742 in Treatment-Naïve Subjects with Chronic HCV GT1, GT4, and GT6 Infection who are on Opiate Substitution Therapy.
Merck Sharp & Dohme Corp., a subsidiary of Merck & Co.,0 sites300 target enrollmentApril 17, 2014
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Hepatitis C
- Sponsor
- Merck Sharp & Dohme Corp., a subsidiary of Merck & Co.,
- Enrollment
- 300
- Status
- Active, not recruiting
- Last Updated
- 6 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •You are greater than or equal to 18 years of age.
- •You have chronic genotype 1, 4, 5, or 6 Hepatitis C virus.
- •You must be on opiate substitution therapy (OST), have kept at least 80% of scheduled appointments while on OST, and not missed any scheduled appointments between screening and study entry
- •You have had a liver biopsy, Fibroscan, or Fibrotest to check for cirrhosis or no cirrhosis.
- •You are treatment naïve to all HCV treatment
- •You may be co\-infected with HIV
- •\- You have received at least one dose of MK\-5172 in combination with MK\-8742 as detailed in
- •\- You understand the study procedures, alternative treatments available, risks involved with the
- •study, and voluntarily agree to participate by giving written informed consent.
- •Are the trial subjects under 18? no
Exclusion Criteria
- •You have signs of decompensated liver disease.
- •You are coinfected with Hepatitis B virus.
- •You have signs of hepatocellular carcinoma or history of malignancy.
- •You are taking or plan to take any medication not allowed for this study.
- •You have a history of, or signs of, chronic hepatitis not caused by hepatitis C virus.
- •You have an exclusionary laboratory value
- •If you have HIV, you use HIV drugs other than a dual NRTI backbone of tenofovir or abacavir and either emtricitabine or lamivudine PLUS raltegravir \[or dolutegravir or rilpivine]
- •You have a history of opportunistic infection in the preceding 6 months prior to screening.
- •\- You are mentally or legally incapacitated, have significant emotional problems at the time of
- •pre\-study screening visit or expected during the conduct of the study or have a history
Outcomes
Primary Outcomes
Not specified
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