Efficacy and Safety Study of Simeprevir in Combination With Sofosbuvir in Participants With Chronic Hepatitis C Virus Infection Without Cirrhosis

Completed · Phase 3

Conditions studied: Hepatitis C Virus Infection

In brief

The purpose of the study is to evaluate the efficacy and safety of a treatment regimen of 12 weeks or 8 weeks of simeprevir in combination with sofosbuvir in chronic hepatitis C virus (HCV) genotype 1 infected men and women without cirrhosis who are HCV treatment-naïve or treatment-experienced.

Key facts

Study ID

NCT02114177

Run by

Janssen Infectious Diseases BVBA

People needed

310

Starts

2014-04-01

Expected to finish

2015-04-01

Last updated by the study team

2016-04-12

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 1a or 1b infection confirmed before randomization
• Documentation of the presence or absence of a NS3 Q80K polymorphism in HCV genotype 1a infected participants before randomization
• Documentation of the IL28B genotype before randomization
• HCV ribonucleic acid level 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
• Absence of cirrhosis in participants

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 1a or 1b
• 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 — Jacksonville, 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 — Zephyrhills, Florida, United States
• Study site — Atlanta, Georgia, United States
• Study site — Columbus, Georgia, United States
• Study site — Marietta, Georgia, United States
• Study site — Indianapolis, Indiana, 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 — Manhasset, New York, United States
• Study site — New York, New York, United States
• Study site — Asheville, North Carolina, United States

Full record on ClinicalTrials.gov

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