Latino Study - A Study of PEGASYS (Peginterferon Alfa-2a (40KD)) and COPEGUS (Ribavirin) in Treatment-Naive Patients With Chronic Hepatitis C-Genotype 1.
NCT ID: NCT00107653
Last Updated: 2016-06-21
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE4
569 participants
INTERVENTIONAL
2004-10-31
2007-09-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Latino
Participants received peginterferon alfa-2a 180 microgram (mcg)/0.5 mL by subcutaneous injection once a week in combination with ribavirin 1000 or 1200 mg per day, which was taken orally in split doses for 48 weeks. Participants with \<75 kg (165 lbs) of body weight received 1000 mg/day (400 mg in the morning and 600 mg in the evening). Participants with \>=75 kg (165 lbs) of body weight received 1200 mg/day (600 mg in the morning and 600 mg in the evening).
Ribavirin
1000-1200mg po daily for 48 weeks
Peginterferon alfa-2a
180 micrograms sc/week for 48 weeks
Non-Latino White
Participants received peginterferon alfa-2a 180 mcg/0.5 mL by subcutaneous injection once a week in combination with ribavirin 1000 or 1200 mg per day which was taken orally in split doses. Participants with \<75 kg (165 lbs) of body weight received 1000 mg/day. Participants with \>=75 kg (165 lbs) of body weight received 1200 mg/day for 48 weeks.
Ribavirin
1000-1200mg po daily for 48 weeks
Peginterferon alfa-2a
180 micrograms sc/week for 48 weeks
Interventions
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Ribavirin
1000-1200mg po daily for 48 weeks
Peginterferon alfa-2a
180 micrograms sc/week for 48 weeks
Ribavirin
1000-1200mg po daily for 48 weeks
Peginterferon alfa-2a
180 micrograms sc/week for 48 weeks
Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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
18 Years
65 Years
ALL
No
Sponsors
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Hoffmann-La Roche
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Trials
Role: STUDY_DIRECTOR
Hoffmann-La Roche
Locations
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Scottsdale, Arizona, United States
Tucson, Arizona, United States
Anaheim, California, United States
Fountain Valley, California, United States
Fresno, California, United States
Lancaster, California, United States
Los Angeles, California, United States
Los Angeles, California, United States
Los Angeles, California, United States
Palo Alto, California, United States
Redlands, California, United States
Sacramento, California, United States
San Bernardino, California, United States
San Diego, California, United States
San Diego, California, United States
San Diego, California, United States
San Diego, California, United States
San Francisco, California, United States
San Luis Obispo, California, United States
Ventura, California, United States
Pueblo, Colorado, United States
Boca Raton, Florida, United States
Bradenton, Florida, United States
Miami, Florida, United States
North Miami Beach, Florida, United States
Plantation, Florida, United States
Austell, Georgia, United States
Chicago, Illinois, United States
Chicago, Illinois, United States
Gurnee, Illinois, United States
Indianapolis, Indiana, United States
Baton Rouge, Louisiana, United States
New Orleans, Louisiana, United States
Baltimore, Maryland, United States
Framingham, Massachusetts, United States
Worcester, Massachusetts, United States
St Louis, Missouri, United States
Vineland, New Jersey, United States
Bayside, New York, United States
New York, New York, United States
Rochester, New York, United States
Chapel Hill, North Carolina, United States
Fayetteville, North Carolina, United States
Philadelphia, Pennsylvania, United States
Philadelphia, Pennsylvania, United States
Nashville, Tennessee, United States
Dallas, Texas, United States
Fort Sam Houston, Texas, United States
Fort Worth, Texas, United States
Galveston, Texas, United States
Houston, Texas, United States
Houston, Texas, United States
San Antonio, Texas, United States
San Antonio, Texas, United States
Salt Lake City, Utah, United States
Fairfax, Virginia, United States
Seattle, Washington, United States
Tacoma, Washington, United States
Ponce, , Puerto Rico
Santurce, , Puerto Rico
Countries
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References
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Rodriguez-Torres M, Jeffers LJ, Sheikh MY, Rossaro L, Ankoma-Sey V, Hamzeh FM, Martin P; Latino Study Group. Peginterferon alfa-2a and ribavirin in Latino and non-Latino whites with hepatitis C. N Engl J Med. 2009 Jan 15;360(3):257-67. doi: 10.1056/NEJMoa0805062.
Other Identifiers
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ML18179
Identifier Type: -
Identifier Source: org_study_id
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