MK-5172/MK-8742 in HCV G1, 4, 6 with Inherited Blood Disorders

Phase 1

• Conditions: Hepatitis C; Therapeutic area: Diseases [C] - Virus Diseases [C02]

• Registration Number: EUCTR2014-002356-27-GB
• Lead Sponsor: Merck Sharp & Dohme Limited

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2014-09-01
• Study Completion: 2016-06-14
• Last Update Posted: 30 June 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• 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: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 200
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 0

Exclusion Criteria

1. Evidence of decompensated liver disease.
2. Coinfection with hepatitis B virus (e.g. HBsAg positive).
3. Prior treatment (defined as 1 dose or more) with direct acting antivirals (DAA) therapy.
4. History of malignancy =5 years
5. Evidence of hepatocellular carcinoma (HCC)
6. Has a condition or prestudy laboratory abnormality or history of any illness which might confound the results of the study or pose additional risk to the patient
7. History of chronic hepatitis not caused by HCV,
8. Exclusionary laboratory values

Study & Design

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

Primary Outcome Measures

Name	Time	Method
Main Objective: The main aims of the study are to evaluate the safety and effectiveness of the study drug MK-5172/ MK-8472 (MK-5172A) at reducing the level of detectable genetic material specific to hepatitis C virus (HCV RNA) present in the blood. Success of the treatment will be based on the levels of HCV RNA in the blood 12 weeks after the end of treatment.;Secondary Objective: •To evaluate the effectiveness of MK-5172/MK-8742 by measuring the levels of HCV RNA in the blood 24 weeks after the end of treatment. ;<br> Primary end point(s): •The primary efficacy endpoint will be the SVR12 rate of the subjects in the immediate treatment arm.<br> •The primary PK endpoints for MK-5172 and MK-8742 are C2hr and Ctrough. Additional PK parameters such as AUC0-24 may be calculated using population pharmacokinetic modeling approaches.<br> ;Timepoint(s) of evaluation of this end point: SVR12 (FU Week 12)

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): •The secondary efficacy endpoint is the SVR24 rate of the subjects in the immediate treatment arm.;Timepoint(s) of evaluation of this end point: SVR24 (FU Week 24)