Latino Study - A Study of PEGASYS (Peginterferon Alfa-2a (40KD)) and COPEGUS (Ribavirin) in Treatment-Naive Patients With Chronic Hepatitis C-Genotype 1.

Completed · Phase 4

Conditions studied: Hepatitis C, Chronic

In brief

This single arm study will evaluate the efficacy and safety of PEGASYS (180 micrograms sc weekly) plus ribavirin (1000-1200mg po daily) in treatment-naive Latino patients versus non-Latino Caucasian patients with chronic hepatitis C- genotype 1. The anticipated time on study treatment is 3-12 months and the target sample size is 500+ patients.

Key facts

Study ID

NCT00107653

Run by

Hoffmann-La Roche

People needed

569

Starts

2004-10-01

Expected to finish

2007-09-01

Last updated by the study team

2016-06-21

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• adult patients 18-65 years of age
• chronic hepatitis C , genotype 1
• serologic evidence of CHC infection by an antibody test
• chronic liver disease, consistent with CHC infection on a liver biopsy obtained within the past 18 months
• compensated liver disease
• use of 2 forms of contraception during the study in both men and women

You may not qualify if…

• previous interferon or ribavirin therapy
• systemic antiviral therapy less than 24 weeks before first dose of study drug or expected need for this treatment any time during the study
• medical condition associated with chronic liver disease (eg, hemochromatosis, autoimmune hepatitis, alcoholic liver disease, toxin exposure)
• decompensated liver disease
• women who are pregnant or breastfeeding

Where it is running

• Study site — Tucson, Arizona, United States
• Study site — Anaheim, California, United States
• Study site — Fountain Valley, California, United States
• Study site — Fresno, California, United States
• Study site — Lancaster, California, United States
• Study site — Los Angeles, California, United States
• Study site — Los Angeles, California, United States
• Study site — Los Angeles, California, United States
• Study site — Palo Alto, California, United States
• Study site — Redlands, California, United States
• Study site — Sacramento, California, United States
• Study site — San Bernardino, California, United States
• Study site — San Diego, California, United States
• Study site — San Diego, California, United States
• Study site — San Diego, California, United States
• Study site — San Diego, California, United States
• Study site — San Francisco, California, United States
• Study site — San Luis Obispo, California, United States
• Study site — Ventura, California, United States
• Study site — Pueblo, Colorado, United States
• Study site — Boca Raton, Florida, United States
• Study site — Bradenton, Florida, United States
• Study site — Miami, Florida, United States
• Study site — North Miami Beach, Florida, United States
• Study site — Scottsdale, Arizona, United States

Full record on ClinicalTrials.gov

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