A Phase III Randomized Clinical Trial to Study the Efficacy and Safety of the Combination Regimen of MK-5172/MK-8742 in Subjects who have Failed Prior Treatment with Pegylated Interferon and Ribavirin (P/R) with Chronic HCV GT1, GT4, and GT6 Infectio
- Conditions
- chronic hepatitis C10047438
- Registration Number
- NL-OMON40780
- Lead Sponsor
- Merck Sharp & Dohme (MSD)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 15
1. Be *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. Have documented chronic HCV GT1, GT4, or GT6;4. Have had a liver biopsy, Fibroscan, or Fibrotest to check for cirrhosis;5. Have a previous HCV treatment status that is of non-response, partial response or treatment relapse;6. For HIV-1 co-infection, documented by any licensed rapid HIV test or HIV enzyme or chemiluminescence immunoassay (E/CIA) test kit;7. For HIV-1 co-infection CD4+ T-cell count > 200 cells/mm3 at screening
1. Has evidence of decompensated liver disease;2. Is coinfected with hepatitis B virus (e.g. HBsAg positive).;3. Has previous direct acting antiviral treatment.;4. Has signs of hepatocellular carcinoma or history of malignancy;5. Is taking or plans to take (a) any HIV therapy, or other medication not allowed for the study;6. Have an exclusionary laboratory value
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>efficacy: Plasma HCV RNA levels according to SVR12</p><br>
- Secondary Outcome Measures
Name Time Method <p>efficacy: Plasma HCV RNA levels according to SVR4<br /><br><br /><br>safety: The safety and tolerability of MK-5172 in combination with MK-8742 are<br /><br>assessed by a clinical evaluation of adverse events and inspection of other<br /><br>study parameters including vital signs, physical examinations, etc.<br /><br><br /><br>PK: C2hr for MK-5172 and MK-8742, and Ctrough for MK-5172, MK-8742 and<br /><br>ribavirin.</p><br>