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

Information source: Hoffmann-La Roche
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Hepatitis C, Chronic

Intervention: Copegus (Drug); peginterferon alfa-2a [Pegasys] (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: Hoffmann-La Roche

Official(s) and/or principal investigator(s):
Clinical Trials, Study Director, Affiliation: Hoffmann-La Roche

Summary

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.

Clinical Details

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

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Percentage of patients with sustained virologic response

Secondary outcome:

Percentage of patients with early virologic response

Percentage of patients with virologic response

AEs, laboratory parameters, premature withdrawals

Eligibility

Minimum age: 18 Years. Maximum age: 65 Years. Gender(s): Both.

Criteria:

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

Locations and Contacts

Ponce 00716, Puerto Rico

Santurce 00909, Puerto Rico

Scottsdale, Arizona 85259, United States

Tucson, Arizona 85712, United States

Anaheim, California 92801, United States

Fountain Valley, California 92708, United States

Fresno, California 93721, United States

Lancaster, California 93534, United States

Los Angeles, California 90022, United States

Los Angeles, California 90033, United States

Los Angeles, California 90095, United States

Palo Alto, California 94304-1509, United States

Redlands, California 92373, United States

Sacramento, California 95817, United States

San Bernardino, California 92404, United States

San Diego, California 92103-8465, United States

San Diego, California 92123, United States

San Diego, California 92154, United States

San Diego, California 92161, United States

San Francisco, California 94110, United States

San Luis Obispo, California 93401, United States

Ventura, California 93003, United States

Pueblo, Colorado 81008, United States

Boca Raton, Florida 33428, United States

Bradenton, Florida 34209, United States

Miami, Florida 33125, United States

North Miami Beach, Florida 33162, United States

Plantation, Florida 33324, United States

Austell, Georgia 30106, United States

Chicago, Illinois 60612, United States

Chicago, Illinois 60637, United States

Gurnee, Illinois 60031, United States

Indianapolis, Indiana 46202, United States

Baton Rouge, Louisiana 70890, United States

New Orleans, Louisiana 70115, United States

Baltimore, Maryland 21205, United States

Framingham, Massachusetts 01702, United States

Worcester, Massachusetts 01655, United States

St Louis, Missouri 63110, United States

Vineland, New Jersey 08360, United States

Bayside, New York 11358, United States

New York, New York 10029, United States

Rochester, New York 14618, United States

Chapel Hill, North Carolina 27599-7584, United States

Fayetteville, North Carolina 28304, United States

Philadelphia, Pennsylvania 19107, United States

Philadelphia, Pennsylvania 19141, United States

Nashville, Tennessee 37211, United States

Dallas, Texas 75203, United States

Fort Sam Houston, Texas 78234-3879, United States

Fort Worth, Texas 76107, United States

Galveston, Texas 77555, United States

Houston, Texas 77030, United States

Houston, Texas 77090, United States

San Antonio, Texas 78215, United States

San Antonio, Texas 78258, United States

Salt Lake City, Utah 84121, United States

Fairfax, Virginia 22031, United States

Seattle, Washington 98133, United States

Tacoma, Washington 98405, United States

Additional Information

Starting date: August 2004
Last updated: August 17, 2015

Page last updated: August 23, 2015

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