Hepatitis C Virus Infection MedDRA version: 14.1 Level: PT Classification code 10019744 Term: Hepatitis C System Organ Class: 10021881 - Infections and infestations
Conditions
Interventions
Product Name: MK-5172
Product Code: MK-5172
Pharmaceutical Form: Tablet
INN or Proposed INN: MK-5172
Current Sponsor code: MK-5172
Other descriptive name: MK-5172
Concentration unit: mg milligram(s)
C
Sponsors
Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., USA
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patient is =18 years of age on day of signing informed consent. 2. Patient has a body weight = 40 kg (88 lbs) and = 125 kg (275 lbs). 3. Patient has previously documented CHC GT 1 infection. Patients with other or mixed genotypes are not eligible. 4.Patient has HCV RNA value =10,000 IU/mL at screening. 5. Absence (no medical history or physical findings) of ascites, bleeding esophageal varices, hepatic encephalopathy, or other signs or symptoms of decompensated liver disease. 6. For the PTF population, 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: Null Response: =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Patient is under the age of legal consent, is mentally or legally incapacitated, has significant emotional problems at the time of pre-study screening visit or expected during the conduct of the study or has a history of a clinically significant psychiatric disorder which, in the opinion of the investigator, would interfere with the study procedures. 2. Patient is HIV positive or known to be coinfected with hepatitis B virus (HBsAg positive). 3. For the PTF patient population, patient received peg-IFN or RBV within 3 months prior to the start of study therapy. 4. For the PTF population, patient met the criterion for relapse in prior HCV therapy (defined as detectable HCV RNA after completion of 48 weeks or more of treatment in patients who achieved undetectable HCV RNA and maintained undetectable HCV RNA throughout the remainder of the treatment period). 5. For the PTF population, pateint failed a prior regimen that included a first generation protease inibititor (e.g., boceprevir and telaprevir). 6. TN patient received prior approved or investigational treatment for hepatitis C; other than herbal remedies,except those with known hepatotoxicity. 7. PTF patient received investigational treatment for hepatitis C: other than herbal remedies, except those with known hepatotoxicity. 8. Cirrhotic patient has an alfa-fetoprotein level of 100 ng/mL or greater. 9. Patient has evidence of hepatocellular carcinoma (HCC) or is under evaluation for HCC. 10. Patient is taking or plans to take any of the following medications: 10.1 Significant inducers or inhibitors of CYP3A4 2 weeks prior to start of study medications (see Prohibited Medications, Section 3.2.1 for further guidance). 10.2 Herbal supplements, including but not limited to St. John’s Wort (Hypericum perforatum) 2 weeks prior to start of study medications (Day 1). Only silymarin (Milk Thistle, Silybum marianum) is permitted during the trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the antiviral activity of each of the four arms of MK-5172(arms 1, 2, 3, and 4) administered in combination with Peg-IFN alfa-2b and RBV as assessed by the proportion of patients achieving undetectable HCV RNA at Week 12 (complete Early Viral Response, cEVR). To evaluate the safety and tolerability of each of the four arms of MK-5172 in combination with Peg-IFN alfa-2b and RBV relative to the control regimen (arm 5).;Secondary Objective: To evaluate the antiviral activity and efficacy of each of the four treatment arms of MK-5172 in combination with Peg-IFN alfa-2b and RBV, as assessed by the time to first achievement of undetectable HCV RNA. To evaluate the antiviral activity and efficacy of each of the four treatment arms of MK-5172in combination with Peg-IFN alfa-2b and RBV as assessed by the proportion of patients achieving undetectable HCV RNA: - At Week 4 (Rapid Viral Response [RVR]) - 12 weeks after the end of all study therapy (Sustained Viral Response, SVR12) - 24 weeks after the end of all study therapy (Sustained Viral Response, SVR24) - At Week 72;Primary end point(s): The proportion of patients achieving undetectable HCV RNA at Week 12 (complete Early Viral Response, cEVR). | — |
Countries
Argentina, Belgium, Canada, France, Germany, Israel, Italy, Puerto Rico, United States
Contacts
Public ContactRenate Prinzing
MSD Sharp & Dohme GmbH
Outcome results
None listed