A Phase III Double Blind Clinical Trial to Study the Efficacy and Safety of the Combination Regimen of MK-5172 and MK-8742 in Subjects with Chronic HCV GT1, GT4 and GT6 Infection with Inherited Blood Disorders with and without HIV Co-Infection - MK-5172/MK-8742 in HCV G1, 4, 6 with Inherited Blood Disorders

Phase 1

• Conditions: Hepatitis C; MedDRA version: 17.0Level: LLTClassification code 10047457Term: Viral hepatitis CSystem Organ Class: 100000004862; Therapeutic area: Diseases [C] - Virus Diseases [C02]

• Registration Number: EUCTR2014-002356-27-IT
• Lead Sponsor: Merck Sharp & Dohme Corp., a subsidiary of Merck & Co.,

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2014-08-28
• Study Completion: 2016-06-14
• Last Update Posted: 21 December 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 159

Inclusion Criteria

1.=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.documented chronic HCV GT1, GT4 and/or GT6
4.HCV treatment status that is one of the following: HCV Treatment Naïve or HCV Treatment experienced (non DAA treatment)
5.have a diagnosis of Sickle Cell (SS) Disease, ß-Thalassemia or Hemophilia A or B or Von Willebrand 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 150
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 50

Exclusion Criteria

1.Coinfection with hepatitis B virus (e.g. HBsAg positive).
2.Prior treatment (defined as 1 dose or more) with direct acting antivirals (DAA) therapy.
3.History of malignancy =5 years
4.Evidence of hepatocellular carcinoma (HCC)
5.History of chronic hepatitis not caused by HCV,
6.Exclusionary laboratory values

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified