A Study of PEGASYS (Peginterferon Alfa-2a (40KD)) in Combination With Ribavirin in Patients With Chronic Hepatitis C (CHC) Previously Treated With PEG-Intron + Ribavirin

Completed · Phase 4

Conditions studied: Hepatitis C, Chronic

In brief

This study will evaluate the efficacy, safety and tolerability of PEGASYS plus ribavirin in patients with CHC who could not tolerate or were not responsive to 12 weeks of therapy with PEG-Intron plus ribavirin. The anticipated time on study treatment is 1-2 years, and the target sample size is \>100 individuals.

Key facts

Study ID

NCT00087568

Run by

Hoffmann-La Roche

People needed

57

Starts

2003-01-01

Expected to finish

2006-03-01

Last updated by the study team

2016-06-08

Who can join

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

You may qualify if…

• adult patients at least 18 years of age
• CHC infection, genotype 1
• unable to tolerate or not responsive to PEG-Intron + ribavirin therapy after 12 weeks of treatment
• use of 2 forms of contraception during the study in both men and women

You may not qualify if…

• women who are pregnant or breast-feeding
• medical condition associated with chronic liver disease (eg, hemochromatosis, autoimmune hepatitis, alcoholic liver disease, toxin exposures)
• patients with decompensated cirrhosis
• patients receiving any systemic antiviral therapy or investigational drug, other than PEG-Intron + ribavirin, 24 weeks prior to the first dose of study drug

Where it is running

• Study site — Bakersfield, California, United States
• Study site — Pasadena, California, United States
• Study site — San Diego, California, United States
• Study site — San Mateo, California, United States
• Study site — Bradenton, Florida, United States
• Study site — Miami, Florida, United States
• Study site — Orlando, Florida, United States
• Study site — Austell, Georgia, United States
• Study site — Annapolis, Maryland, United States
• Study site — Baltimore, Maryland, United States
• Study site — Boston, Massachusetts, United States
• Study site — Kansas City, Missouri, United States
• Study site — Bayside, New York, United States
• Study site — Brooklyn, New York, United States
• Study site — Manhasset, New York, United States
• Study site — New York, New York, United States
• Study site — Valhalla, New York, United States
• Study site — Statesville, North Carolina, United States
• Study site — Cincinnati, Ohio, United States
• Study site — Knoxville, Tennessee, United States
• Study site — Memphis, Tennessee, United States
• Study site — Houston, Texas, United States
• Study site — Fairfax, Virginia, United States
• Study site — Richmond, Virginia, United States
• Study site — Tacoma, Washington, United States

Full record on ClinicalTrials.gov

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