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.
- Conditions
- Chronic Hepatitis C10047438
- Registration Number
- NL-OMON42051
- Lead Sponsor
- Merck Sharp & Dohme (MSD)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 4
Part A:
*You are greater than or equal to 18 years of age.;*You have chronic genotype 1, 4, 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;Part B:
- have received at least one dose of MK-5172 in combination with MK-8742 as detailed in
Part A.
- understand the study procedures, alternative treatments available, risks involved with the
study, and voluntarily agrees to participate by giving written informed consent.
Deel A:
*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 NNRTI 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.;Part B:
- is mentally or legally incapacitated, has significant emotional problems at the time of
pre-study screening visit or expected during the conduct of the study or has a history
of a clinically significant psychiatric disorder which, in the opinion of the
investigator, would interfere with the study procedures.
- The subject has a medical condition or personal circumstance which, in the opinion of
the investigator and/or Sponsor, places the subject at unnecessary risk through
continued participation in the trial or does not allow the subject to adhere to the
requirements of the protocol.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Efficacy outcome: plasma HCV RNA level following SVR12<br /><br><br /><br>Safety outcome: The safety and tolerability of MK-5172 in combination with<br /><br>MK-8742 are assessed by a clinical evaluation of adverse events and inspection<br /><br>of other study param eters including vital signs, physical examinations, etc.<br /><br><br /><br>PK outcome: C(2hr) en C(through)</p><br>
- Secondary Outcome Measures
Name Time Method <p>Part A: Efficacy outcome: plasma HCV RNA level following SVR4 and SVR24<br /><br>Part B: primary measurement is plasma HCV RNA, collected every 6<br /><br>months to evaluate long term durability of SVR and incidence of<br /><br>reinfection in subjects with detectable HCV RNA.</p><br>