A Study to Examine Patient Characteristics, Health Care Management and Health Outcomes of Hepatitis C Virus (HCV) Patients Treated With Simeprevir

Completed

Conditions studied: Hepatitis C Virus

In brief

The purpose of this study is to evaluate the effectiveness of a simeprevir-containing hepatitis C virus (HCV) treatment regimen as measured by sustained virologic response (SVR).

Key facts

Study ID

NCT02103699

Run by

Janssen Scientific Affairs, LLC

People needed

315

Starts

2014-02-01

Expected to finish

2016-01-01

Last updated by the study team

2016-02-22

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patients who have genotype 1 chronic hepatitis C infection
• Hepatitis C virus (HCV) ribonucleic acid (RNA) test result above the limit of quantification before initiation of simeprevir-based therapy
• Health care provider decision to treat patient with a simeprevir-based therapy, inclusive of patients who have been treated with a simeprevir-based therapy for less than or equal to (<=) 28 days will be enrolled into the study
• Prior HCV treatment must be completed more than 3 months before initiation of simeprevir-based therapy
• In the opinion of the health care provider, the patient will attend routine standard of care visits, either at enrolled site or by virtual/telemedicine

You may not qualify if…

• Non-genotype 1 HCV infected patients
• Absolute contraindication to any component of prescribed HCV treatment per prescribing information
• Patient is currently enrolled in an interventional study
• Past use of an HCV direct-acting antiviral therapy
• Any investigational drug use within 30 days before initiation of simeprevir-based therapy

Where it is running

• Study site — Phoenix, Arizona, United States
• Study site — Bakersfield, California, United States
• Study site — Beverly Hills, California, United States
• Study site — Los Angeles, California, United States
• Study site — Daytona Beach, Florida, United States
• Study site — DeLand, Florida, United States
• Study site — Miami, Florida, United States
• Study site — Tampa, Florida, United States
• Study site — West Palm Beach, Florida, United States
• Study site — Crestview Hills, Kentucky, United States
• Study site — Baltimore, Maryland, United States
• Study site — Springfield, Massachusetts, United States
• Study site — Newark, New Jersey, United States
• Study site — Vineland, New Jersey, United States
• Study site — Brooklyn, New York, United States
• Study site — Flushing, New York, United States
• Study site — New York, New York, United States
• Study site — Durham, North Carolina, United States
• Study site — Fayetteville, North Carolina, United States
• Study site — Rocky Mount, North Carolina, United States
• Study site — Statesville, North Carolina, United States
• Study site — Winston-Salem, North Carolina, United States
• Study site — Cincinnati, Ohio, United States
• Study site — Doylestown, Pennsylvania, United States
• Study site — Philadelphia, Pennsylvania, United States

Full record on ClinicalTrials.gov

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