Chronic hepatitis C infection Infección crónica por Hepatitis C MedDRA version: 9.1 Level: LLT Classification code 10019751 Term: Hepatitis C virus
Conditions
Interventions
Product Code: MK-7009
Pharmaceutical Form: Capsule*
Concentration type: equal
Concentration number: 5 mg per Capsule-
Pharmaceutical for
Sponsors
Merck Sharp & Dohme de España, S.A.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Men and women 18 to 65 years of age (inclusive). 2. Chronic, compensated, genotype 1 HCV infection as defined by: - Positive serology for HCV with HCV RNA levels =4 x 105 IU/mL in peripheral blood at screening (within 75 days prior to first dose of MK-7009). - Evidence of chronic HCV infection as assessed by positive serology for HCV or detectable HCV RNA =6 months prior to study drug administration. - Absence (no medical history or physical findings) of ascites, bleeding esophageal varices, hepatic encephalopathy, or other signs or symptoms of advanced liver 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 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Patient had previous treatment with: - Three or more doses of IFN, peg-IFN, and/or ribavirin. - IFN, peg-IFN, and/or ribavirin and discontinued treatment due to intolerance to one or more of these therapies. - Other antiviral or investigational therapies or vaccines for HCV. 2. Patient has evidence or history of chronic hepatitis not caused by HCV, including but not limited to nonalcoholic steatohepatitis (NASH), drug-induced hepatitis, and autoimmune hepatitis. (Note: Patients with history of acute non-HCV-related hepatitis, which resolved >6 months before study entry, can be enrolled.) 3. Evidence of cirrhosis from prior liver biopsy or approved non-invasive imaging assessment within 3 years of study entry. 4. Patient has non-genotype 1 HCV infection, including mixed genotype. 5. Patient has any other condition that is contraindicated for treatment with peg-IFN or ribavirin, for example: - Major, uncontrolled depressive illness - Solid major organ transplant recipient (i.e., liver, renal, heart, or lung) - Untreated hyperthyroidism - Severe concurrent disease such as severe hypertension, congestive heart failure, significant coronary artery disease, poorly controlled diabetes mellitus, obstructive pulmonary disease, or chronic renal disease - Known hypersensitivity to drugs used to treat HCV - Other serious medical condition which could be exacerbated by peg-IFN and/or ribavirin, in the opinion of the investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the activity, as measured by the proportion of patients achieving RVR (undetectable viral load at Week 4), and the safety and tolerability, as assessed by review of the accumulated safety data, of MK-7009 compared with placebo when each are administered concomitantly with peg-IFN and ribavirin for 28 days in treatment-naïve patients with chronic HCV genotype 1 infection with pre-treatment HCV RNA of at least 4 x 105 IU/mL.;Secondary Objective: To evaluate the activity of MK-7009 compared with placebo when each is administered concomitantly with peg-IFN and ribavirin for 28 days, as measured by: (1) the proportion of patients achieving =2-log decrease in viral load from baseline to Week 4, (2) the proportion of patients achieving =3-log decrease in viral load from baseline to Week 4, and (3) the mean log decrease in viral load from baseline to Week 4.;Primary end point(s): The primary efficacy endpoint will be the proportion of patients achieving rapid viral response (i.e., undetectable HCV viral RNA at Week 4). | — |
Countries
Austria, Czech Republic, Denmark, France, Germany, Spain
Outcome results
None listed