Hepatitis C
Conditions
Interventions
Product Name: MK-5172
Product Code: MK-5172
Pharmaceutical Form: Tablet
INN or Proposed INN: NA
Current Sponsor code: MK-5172
Sponsors
Merck Sharp & Dohme Corp., a subsidiary of Merck & Co.,
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Part A: •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 Part B: - You have received at least one dose of MK-5172 in combination with MK-8742 as detailed in Part A. - 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 Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 300 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Part 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 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. Part B: - 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 of a clinically significant psychiatric disorder which, in the opinion of the investigator, would interfere with the study procedures. - You have a medical condition or personal circumstance which, in the opinion of the investigator and/or Sponsor, places you at unnecessary risk through continued participation in the trial or does not allow you to adhere to the requirements of the protocol.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: •To evaluate the efficacy of MK-5172 in combination with MK-8742 as assessed by the proportion of subjects achieving SVR12 (Sustained Virologic Response 12 weeks after the end of all study therapy), defined as HCV RNA <LLOQ (either TD[u] or TND) 12 weeks after the end of all study therapy. •To evaluate the safety and tolerability of MK-5172 in combination with MK-8742. ; Secondary Objective: Part A 1) To evaluate the efficacy of MK-5172 in combination with MK-8742 as assessed by the proportion of subjects achieving: SVR24 (Sustained Virologic Response 24 weeks after the end of all study therapy), defined as HCV RNA <LLOQ (either TD(u) or TND) 24 weeks after the end of all study therapy. Part B 1) To evaluate the durability of SVR and the incidence of detectable HCV RNA, classified as either relapse or reinfection, over a three year follow-up period following the treatment/follow-up as defined in Part A . 2) To characterize the HCV virus detected during the Part A treatment and follow-up periods and as well as in the Part B 3-year follow-up period including: a. To describe the presence of baseline viral resistance-associated variants (RAVs) b. To describe treatment emergent RAVs c. To determine reinfection versus relapse ;Primary end point(s): The SVR12 rate of subjects enrolled.; Timepoint(s) of evaluation of this end point: SVR12 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Part A: The SVR24 rate of subjects enrolled. Part B: primary measurement is plasma HCV RNA, collected every 6 months to evaluate long term durability of SVR and incidence of reinfection in subjects with detectable HCV RNA. ;Timepoint(s) of evaluation of this end point: SVR24 | — |
Countries
Australia, Belgium, Canada, France, Germany, Greece, Ireland, Israel, Italy, Lithuania, Malaysia, Netherlands, New Zealand, Norway, Romania, Spain, Taiwan, United Kingdom, United States
Contacts
Public ContactGlobal Clinical Trials Operations
Merck Sharp & Dohme Corp., a subsidiary of Merck & Co.
Outcome results
None listed