Efficacy and Safety Study of Simeprevir in Combination With Sofosbuvir in Participants With Genotype 1 Chronic Hepatitis C Virus Infection and Cirrhosis

Completed · Phase 3

Conditions studied: Hepatitis C Virus Infection

In brief

The purpose of the study is to investigate the efficacy and safety of 12 weeks of simeprevir (150 mg qd) in combination with sofosbuvir (400 mg qd) in chronic hepatitis C virus (HCV) genotype 1 infected men and women with cirrhosis who are HCV treatment-naïve or treatment-experienced.

Key facts

Study ID

NCT02114151

Run by

Janssen Infectious Diseases BVBA

People needed

103

Starts

2014-04-01

Expected to finish

2015-04-01

Last updated by the study team

2016-04-04

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Hepatitis C virus (HCV) genotype 1 infection (confirmed at screening).
• HCV ribonucleic acid (RNA) greater than 10,000 IU/mL at screening
• Treatment-experienced participants must have at least 1 documented previous course of interferon-based regimen with or without ribavirin
• Participants must have an hepatic imaging procedure (ultrasound, computerized tomography scan or magnetic resonance imaging scan) within 6 months prior to the screening visit (or between screening and Day 1) with no findings suspicious for hepatocellular carcinoma
• Participant must be willing and able to comply with the protocol requirements
• Participants with liver cirrhosis

You may not qualify if…

• Evidence of clinical hepatic decompensation (history or current evidence of ascites, bleeding varices or hepatic encephalopathy)
• Infection/co-infection with HCV non-genotype 1
• Co-infection with human immunodeficiency virus (HIV) type 1 or type 2 (HIV-1 or HIV-2) (positive HIV-1 or HIV-2 antibodies test at screening)
• Co-infection with hepatitis B virus (hepatitis B-surface-antigen positive)
• Previously been treated with any direct acting anti-HCV agent (approved or investigational) for chronic HCV infection

Where it is running

• Study site — Dothan, Alabama, United States
• Study site — Bakersfield, California, United States
• Study site — Chula Vista, California, United States
• Study site — Los Angeles, California, United States
• Study site — San Diego, California, United States
• Study site — Englewood, Colorado, United States
• Study site — Bradenton, Florida, United States
• Study site — Lauderdale Lakes, Florida, United States
• Study site — Maitland, Florida, United States
• Study site — Miami, Florida, United States
• Study site — Orlando, Florida, United States
• Study site — Wellington, Florida, United States
• Study site — Atlanta, Georgia, United States
• Study site — Columbus, Georgia, United States
• Study site — Marietta, Georgia, United States
• Study site — Jackson, Mississippi, United States
• Study site — Kansas City, Missouri, United States
• Study site — Hillsborough, New Jersey, United States
• Study site — Vineland, New Jersey, United States
• Study site — New York, New York, United States
• Study site — Asheville, North Carolina, United States
• Study site — Winston-Salem, North Carolina, United States
• Study site — East Greenwich, Rhode Island, United States
• Study site — Providence, Rhode Island, United States
• Study site — Greer, South Carolina, United States

Full record on ClinicalTrials.gov

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