Hepatitis C MedDRA version: 18.0 Level: LLT Classification code 10019751 Term: Hepatitis C virus System Organ Class: 100000004848
Conditions
Interventions
Product Name: MK 5172A
Pharmaceutical Form: Film-coated tablet
Other descriptive name: MK-5172
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 100-
Other descriptiv
Sponsors
Merck Corporation, Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: •You are greater than or equal to 18 years of age •You have chronic HCV GT1 •You have had a liver biopsy, Fibroscan or Fibrotest to check for cirrhosis or no cirrhosis •Have documented chronic HCV GT 1, 4 or 6 (with no evidence of non-typeable or mixed genotype) infection: -Positive for anti-HCV antibody, HCV RNA, or HCV GT 1, 4 or 6 at least 6 months before screening (HCV RNA and HCV genotype must be confirmed by screening lab results), or -Positive for anti-HCV antibody or HCV RNA at the time of screening with a liver biopsy consistent with chronic HCV infection (or a liver biopsy performed before enrollment with evidence of CHC disease, such as the presence of fibrosis) 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 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: •You have signs of decompensated liver disease •You are coninfected with Hepatitis B •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 pre-existing psychiatric condition •You have an exclusionary laboratory value •You intend to become pregnant or plan to impregnate during the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: •To compare MK-5172A to SOF/PR in the treatment of HCV, 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-5172A as compared to SOF/PR. ;Secondary Objective: •To evaluate the safety profile of MK-5172A as compared to SOF/PR, as assessed by the proportion of subjects experiencing a Tier 1 safety event, as defined as: -any serious drug-related adverse event (AE) -any drug-related AE leading to permanent discontinuation of all study drugs -neutrophil count <0.75 x 109/L -hemoglobin <10 g/dL -any event leading to discontinuation of study drug as defined in Section 5.8 numbers 6-13 (of the protocol) •To evaluate whether MK-5172A has superior efficacy to SOF/PR in the treatment of HCV, 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. ;Primary end point(s): The SVR12 rate of the subjects in the MK-5172A arm compared to that in the SOF/PR arm.;Timepoint(s) of evaluation of this end point: SVR12 (baseline and follow-up Week 12) | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): •SVR4 (Sustained Virologic Response 4 weeks after the end of all study therapy):.Follow-up Week 24 •SVR24 (Sustained Virologic Response 24 weeks after the end of all study therapy):.Follow-up Week 24 ;Timepoint(s) of evaluation of this end point: SVR24 (baseline and follow-up Week 24) | — |
Countries
Czech Republic, Denmark, Hungary, Lithuania, Norway, Poland, Spain, Turkey
Contacts
Public ContactGlobal Clinical Trials Operations
Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.
Outcome results
None listed