NCT02165189View on ClinicalTrials.gov

An Efficacy and Safety Study of Simeprevir and Sofosbuvir With and Without Ribavirin in Participants With Recurrent Genotype 1 Hepatitis C Post-Orthotopic Liver Transplant

PHASE2CompletedINTERVENTIONAL
Enrollment

46

Participants

Timeline

Start Date

August 31, 2014

Primary Completion Date

November 30, 2015

Study Completion Date

November 30, 2015

Conditions
Hepatitits C
Interventions
DRUG

Simeprevir

Participants will be administered simeprevir capsule 150 mg orally once daily up to 12 weeks.

DRUG

Sofosbuvir

Participants will be administered sofosbuvir 400 mg tablet orally once daily up to 12 weeks.

DRUG

Ribavirin

Participants will be administered ribavirin 2 x 200 mg tablets (for participants weighing less than 75 kilogram (\[kg\]) or 3 x 200 mg tablets (for participants weighing more than 75 kg) orally once daily up to 12 weeks.

DRUG

Simeprevir

Participants will be administered simeprevir capsule 150 mg orally once daily up to 24 weeks.

DRUG

Sofosbuvir

Participants will be administered sofosbuvir 400 mg tablet orally once daily up to 24 weeks.

Trial Locations (11)

Unknown

Aurora

Gainesville

Miami

Boston

Ann Arbor

Detroit

New York

Durham

Philadelphia

Pittsburgh

Dallas

All Listed Sponsors
lead

Janssen Scientific Affairs, LLC

INDUSTRY

NCT02165189 - An Efficacy and Safety Study of Simeprevir and Sofosbuvir With and Without Ribavirin in Participants With Recurrent Genotype 1 Hepatitis C Post-Orthotopic Liver Transplant | Biotech Hunter | Biotech Hunter