NCT01852604

Samatasvir (IDX719) in Combinations With Simeprevir and/or TMC647055/Ritonavir With or Without Ribavirin for 12 Weeks in Participants With Chronic Hepatitis C Infection (MK-1894-005)

A Randomized Study to Evaluate the Safety and Efficacy of IDX719 in Combinations With Simeprevir and/or TMC647055/Ritonavir With or Without Ribavirin for 12 Weeks in Subjects With Chronic Hepatitis C Infection

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 143 (actual)
• Sponsor: Merck Sharp & Dohme LLC · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

Parts A and B of this study are designed to evaluate the safety, tolerability, efficacy and pharmacokinetic profiles of samatasvir and simeprevir when administered in combination with ribavirin (RBV) for 12 weeks in treatment-naïve, Genotype (GT) 1b, 4 and 6 hepatitic C virus (HCV)-infected participants. Part C of this study is designed to evaluate the safety, tolerability, efficacy and pharmacokinetic profiles of samatasvir, simeprevir, TMC647055 and ritonavir (RTV) when administered in combination with or without RBV for 12 weeks in treatment-naïve or interferon/RBV-treatment relapsed, GT 1a and 1b HCV-infected participants.

Detailed description

Part A of this study is randomized and double-blind. Parts B and C are randomized and open-label.

Conditions

• Chronic Hepatitis C Virus

Interventions

Type	Name	Description
DRUG	Samatasvir	Samatasvir (IDX719) will be supplied as 25 mg and 50 mg oral tablets.
DRUG	Simeprevir	Simeprevir will be supplied as 75 and 150 mg oral capsules.
DRUG	Ribavirin (RBV)	Ribavirin will be supplied as 200 mg oral tablets. Participants in the RBV-free arms experiencing non-response or virologic breakthrough during the treatment period will be offered RBV dosed according to the product label as an add-on to the participant's randomized treatment assignment.
DRUG	TMC647055	TMC647055 will be supplied as 150 mg oral capsules.
DRUG	Ritonavir (RTV)	Ritonavir will be supplied as 80 mg/mL oral solution.
BIOLOGICAL	Pegylated interferon (Peg-IFN)	Participants experiencing non-response or virologic breakthrough during the treatment period will be offered Peg-IFN (subcutaneous injection) dosed according to the product label as an add-on to the participant's randomized treatment assignment.
OTHER	Samatasvir matching placebo	Samatasvir matching placebo will be supplied for the 50 mg tablets used in Part A.

Timeline

• Start date: 2013-03-01
• Primary completion: 2015-04-01
• Completion: 2015-04-01
• First posted: 2013-05-14
• Last updated: 2015-04-23