An Observational Study of Peginterferon (e.g. Pegasys)-Based Direct Acting Antiviral Triple Therapy in Patients With Chronic Hepatitis C Genotype 1

Completed

Conditions studied: Hepatitis C, Chronic

In brief

This prospective observational study will evaluate the efficacy and safety of two approved pegylated interferon-based direct acting antiviral triple therapies in patients with chronic hepatitis C genotype 1. Patients receiving pegylated interferon (e.g. Pegasys) and ribavirin plus either telaprevir or boceprivir in accordance with local standard of care and US labeling will be followed for the duration of their treatment and for up to 24 weeks post-treatment.

Key facts

Study ID

NCT01508130

Run by

Hoffmann-La Roche

People needed

672

Starts

2012-01-31

Expected to finish

2014-03-31

Last updated by the study team

2017-04-10

Who can join

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

You may qualify if…

• Adult patients, >/= 18 years of age
• Chronic hepatitis C, genotype 1
• Receiving pegylated interferon-based direct acting antiviral therapy (pegylated interferon and ribavirin plus either telaprevir or boceprivir) in accordance with local standard of care and US labeling

You may not qualify if…

• Contraindications per US labels

Where it is running

• Univ. of Alabama at Birmingham; The Kirklin Clinic — Birmingham, Alabama, United States
• Liver Wellness Center — Little Rock, Arkansas, United States
• Loma Linda University Medical Center and Liver Center — Loma Linda, California, United States
• HMRI Liver Center — Pasadena, California, United States
• Kaiser Permanente San Diego; Hepatology Research — San Diego, California, United States
• VA San Diego Healthcare System — San Diego, California, United States
• South Bay Gastroenterology Medical Group — Torrance, California, United States
• University of Colorado Denver — Aurora, Colorado, United States
• Litchfield County Gastroenterology Associates — Torrington, Connecticut, United States
• Consultive Medicine — Daytona Beach, Florida, United States
• Florida Center for Gastroenterology — Largo, Florida, United States
• Center for Advanced Gastroenterology — Maitland, Florida, United States
• Internal Medicine Specialists — Orlando, Florida, United States
• Orlando Infectious Disease Center, Pa — Orlando, Florida, United States
• Tampa General Hospital; Tampa General Medical Group — Tampa, Florida, United States
• Atlanta Center for Gastroenterology, PC — Decatur, Georgia, United States
• Dekalb Gastroenterology Associates — Decatur, Georgia, United States
• Gastroenterology Associates of Central Georgia — Macon, Georgia, United States
• University of Chicago — Chicago, Illinois, United States
• Indianapolis Gastroenterology — Indianapolis, Indiana, United States
• Tristate Gastroenerology Associates — Crestview Hills, Kentucky, United States
• Ochsner Clinic Foundation — Baton Rouge, Louisiana, United States
• New Orleans Research Institute. — Metairie, Louisiana, United States
• Tulane Uni Health Sciences Center — New Orleans, Louisiana, United States
• Cooper Green Hospital — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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