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



Status:Completed
Conditions:Hepatitis, Hepatitis, Hepatitis
Therapuetic Areas:Immunology / Infectious Diseases
Healthy:No
Age Range:18 - 65
Updated:4/21/2016
Start Date:August 2004
End Date:February 2008

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An Open-label Study of PEGASYS Plus Ribavirin on Sustained Virological Response in Treatment-naïve Latino White Patients Compared With Non-Latino Caucasian Patients With Chronic Hepatitis C, Genotype 1

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.


Inclusion Criteria:

- adult patients 18-65 years of age

- CHC, 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:

- 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
We found this trial at
50
sites
Framingham, Massachusetts 01702
624
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Framingham, MA
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1962
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Anaheim, CA
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434
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Austell, GA
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344
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Baltimore, MD
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801
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Baton Rouge, LA
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489
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Bayside, NY
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955
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Boca Raton, FL
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862
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Bradenton, FL
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353
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Chapel Hill, NC
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274
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Chicago, IL
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910
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Dallas, TX
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316
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Fairfax, VA
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Fayetteville, North Carolina 28304
408
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Fayetteville, NC
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1134
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Fort Sam Houston, TX
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937
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Fort Worth, TX
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Fountain Valley, California 92708
1965
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Fountain Valley, CA
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1993
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Fresno, CA
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994
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Galveston, TX
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303
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Gurnee, IL
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991
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Houston, TX
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166
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Indianapolis, IN
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1950
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Lancaster, CA
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1972
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Los Angeles, CA
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993
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Miami, FL
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331
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Nashville, TN
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798
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New Orleans, LA
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481
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New York, NY
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North Miami Beach, Florida 33162
983
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North Miami Beach, FL
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2100
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Palo Alto, CA
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416
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Philadelphia, PA
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970
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Plantation, FL
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1805
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Ponce,
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1160
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Pueblo, CO
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1915
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Redlands, CA
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355
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Rochester, NY
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2039
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Sacramento, CA
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1513
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Salt Lake City, UT
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1144
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San Antonio, TX
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San Bernardino, California 92408
1919
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San Bernardino, CA
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1951
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San Diego, CA
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2107
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San Francisco, CA
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San Luis Obispo, California 93405
2069
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San Luis Obispo, CA
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1653
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Scottsdale, AZ
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2005
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Seattle, WA
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394
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St Louis, MO
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2012
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Tacoma, WA
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1639
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Tucson, AZ
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2018
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Ventura, CA
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425
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Vineland, NJ
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604
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Worcester, MA
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