Hepatitis C
Conditions
Interventions
Product Code: MK-5172A
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: MK-5172
Current Sponsor code: MK-5172
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration nu
Sponsors
Merck Sharp & Dohme Corp., a subsidiary of Merck & Co.,
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.=18 years of age on day of signing informed consent. 2.HCV RNA (= 10,000 IU/mL in peripheral blood) at the time of screening. 3.documented chronic HCV GT1, GT4 and/or GT6 4.HCV treatment status that is one of the following: HCV Treatment Naïve or HCV Treatment experienced (non DAA treatment) 5.have a diagnosis of Sickle Cell (SS) Disease, ß-Thalassemia or Hemophilia A or B or Von Willebrand disease 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 200 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1.Coinfection with hepatitis B virus (e.g. HBsAg positive). 2.Prior treatment (defined as 1 dose or more) with direct acting antivirals (DAA) therapy. 3.History of malignancy =5 years 4.Evidence of hepatocellular carcinoma (HCC) 5.History of chronic hepatitis not caused by HCV, 6.Exclusionary laboratory values
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: •To evaluate the efficacy of MK-5172A as assessed by the proportion of subjects in the immediate treatment arm 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-5172A in the immediate treatment group relative to the placebo treatment of the deferred treatment group. ;Secondary Objective: •To evaluate the efficacy of MK-5172/MK-8742 as assessed by the proportion of subjects in the immediate treatment arm 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.;Primary end point(s): •The primary efficacy endpoint will be the SVR12 rate of the subjects in the immediate treatment arm. •The primary PK endpoints for MK-5172 and MK-8742 are C2hr and Ctrough. Additional PK parameters such as AUC0-24 may be calculated using population pharmacokinetic modeling approaches. ;Timepoint(s) of evaluation of this end point: SVR12 (FU Week 12) | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): •The secondary efficacy endpoint is the SVR24 rate of the subjects in the immediate treatment arm.;Timepoint(s) of evaluation of this end point: SVR24 (FU Week 24) | — |
Countries
Australia, Canada, France, Germany, Greece, Israel, Italy, New Zealand, United Kingdom, United States
Contacts
Public ContactGlobal Clinical Trials Operations
Merck Sharp & Dohme Corp., a subsidiary of Merck & Co.,
Outcome results
None listed