MK-5172 in Combination with MK-8742 with and without Ribavirin (RBV) in HCV patients who failed Prior pegylated interferon (peg-IFN) and RBV treatment

Conditions: Hepatitis C
Therapeutic area: Diseases [C] - Virus Diseases [C02]
MedDRA version: 17.1Level: PTClassification code 10019744Term: Hepatitis CSystem Organ Class: 10021881 - Infections and infestations

Registration Number: EUCTR2014-000824-12-NL

Lead Sponsor: Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 400

Inclusion Criteria

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
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 350
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 50

Exclusion Criteria

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 clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: 1.To evaluate the efficacy of MK-5172 in combination with MK-8742 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.<br>2.To evaluate the safety and tolerability of MK-5172 in combination with MK-8742.<br>;Secondary Objective: 1.To evaluate the efficacy of MK-5172 in combination with MK-8742 (+/-RBV) as assessed by the proportion of subjects achieving SVR24 (Sustained Virologic Response 24 weeks after the end of all study therapy), defined as HCV RNA <LLOQ (either TD[u] or TND) 24 weeks after the end of all study therapy.;Primary end point(s): The proportion of subjects achieving SVR12;Timepoint(s) of evaluation of this end point: FU12 wk

Secondary Outcome Measures