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)

PHASE2CompletedINTERVENTIONAL
Enrollment

143

Participants

Timeline

Start Date

March 31, 2013

Primary Completion Date

April 30, 2015

Study Completion Date

April 30, 2015

Conditions
Chronic Hepatitis C Virus
Interventions
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.

All Listed Sponsors
collaborator

Janssen Research & Development, LLC

INDUSTRY

lead

Merck Sharp & Dohme LLC

INDUSTRY

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) | Biotech Hunter | Biotech Hunter