Chronic hepatitis C infection MedDRA version: 9.1 Level: LLT Classification code 10019751 Term: Hepatitis C virus
Conditions
Interventions
Product Name: MK-7009
Product Code: MK-7009
Pharmaceutical Form: Capsule*
Current Sponsor code: MK-7009
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 100mg per ca
Sponsors
Merck & Co., Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients (men and women 18 to 65 years of age) with chronic compensated genotype 1 HCV infection as defined by 1) positive serology for HCV with HCV RNA levels =4 ×105 IU/mL in peripheral blood at screening (within 60 days prior to the first dose of MK-7009); 2) evidence of chronic HCV infection as assessed by positive serology for HCV or detectable HCV RNA =6 months prior to the first dose of MK-7009; and 3) absence (no medical history or physical findings) of ascites, bleeding esophageal varices, hepatic encephalopathy, or other signs or symptoms of advanced liver disease. Patient has received and tolerated coadministered peg-IFN (alfa-2a or -2b) and RBV, but failed to respond to at least one prior treatment course of at least 12 weeks duration. Patient's HCV treatment history (i.e., type of therapy and duration of therapy) and response to prior treatment (i.e., tolerability and HCV RNA data) should be available such that one of the following definitions are met: 1-Null Response: =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Patient has non-genotype 1 HCV infection, including mixed genotype and has evidence or history of chronic hepatitis not caused by HCV, including but not limited to non-alcoholic steatohepatitis (NASH), drug-induced hepatitis, and autoimmune hepatitis. Patient was previously unable to complete 12 weeks of peg-IFN- or RBV-containing regimen due to intolerance of peg-IFN or RBV. In the opinion of the investigator, the patient is unlikely to tolerate at least 24 weeks of continuous therapy with peg-IFN and RBV.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: 1) To evaluate the safety and tolerability of the MK-7009 300 mg b.i.d. treatment regimen and the MK-7009 600 mg b.i.d. treatment regimens as compared with the control regimen, as assessed by review of the accumulated safety data. 2) To evaluate the antiviral activity of the three MK-7009 600 mg b.i.d. treatment regimens as compared with the control regimen, as assessed by the proportion of patients achieving undetectable HCV RNA 24 weeks after the end of all study therapy (Sustained Viral Response 24 [SVR24]). ;Secondary Objective: To evaluate the antiviral activity of the MK-7009 300 mg b.i.d. treatment regimen and the three MK-7009 600 mg b.i.d. treatment regimens as compared with the control regimen, as assessed by comparison of: • the proportion of patients achieving undetectable viral RNA at treatment Week 4 (Rapid Viral Response [RVR]) • the proportion of patients achieving undetectable viral RNA at treatment Week 24. • the proportion of patients achieving undetectable viral RNA at end of all study therapy. • the proportion of patients achieving undetectable viral RNA 12 weeks after the end of all therapy (Sustained Viral Response 12 [SVR12]). • the proportion of patients achieving a >2-log decrease in viral RNA from baseline to treatment Week 12. • mean log10 decreases in plasma viral RNA from baseline to treatment Week 12 in each treatment regimen. ;Primary end point(s): the antiviral activity of the three MK-7009 600 mg b.i.d. treatment regimens as compared with the control regimen, as assessed by the proportion of patients achieving undetectable viral RNA 24 weeks after the end of all study therapy (Sustained Viral Response 24 [SVR24]). Safety and tolerability of the MK-7009 300 mg b.i.d. treatment regimen and the three MK-7009 600 mg b.i.d. treatment regimens as compared with placebo in combination with 48 weeks of peg-IFN and RBV, as assessed by review of the accumulated safety data. | — |
Countries
Austria, Czech Republic, France, Germany, Lithuania, Sweden, United Kingdom
Outcome results
None listed