PEAK Study - A Study of PEGASYS (Peginterferon Alfa-2a (40KD)) in Combination With COPEGUS (Ribavirin) in Interferon-Naive Patients With Chronic Hepatitis C (CHC).



Status:Completed
Conditions:Hepatitis, Hepatitis, Hepatitis
Therapuetic Areas:Immunology / Infectious Diseases
Healthy:No
Age Range:18 - Any
Updated:4/21/2016
Start Date:December 2003
End Date:May 2006

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A Randomized, Open-label Study to Compare the Effect of PEGASYS Plus Ribavirin and PEG-Intron Plus Ribavirin on Viral Load Reduction in Interferon-naïve Patients With Chronic Hepatitis C Viral Infection

This study will examine the viral kinetics and pharmacokinetics of PEGASYS plus ribavirin
and PEG-Intron plus ribavirin in interferon-naive patients with CHC. The anticipated time on
study treatment is 3-12 months, and the target sample size is 100-500 individuals.


Inclusion Criteria:

- adult patients at least 18 years of age

- CHC infection, genotype 1

- use of 2 forms of contraception during study in both men and women

Exclusion Criteria:

- previous systemic therapy with anti-viral, anti-neoplastic, or immunomodulatory
agents

- medical condition associated with chronic liver disease (eg, hemochromatosis,
autoimmune hepatitis, metabolic liver disease, alcoholic liver disease, toxin
exposure)

- decompensated liver disease

- women who are pregnant or breastfeeding
We found this trial at
42
sites
Statesville, North Carolina 28677
2257
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Statesville, NC
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1775
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Austin, TX
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Baltimore, MD
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Birmingham, AL
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Boston, MA
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Bradenton, FL
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Bronx, NY
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Burlington, MA
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1733
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Chicago, IL
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2321
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Columbia, SC
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1682
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Dallas, TX
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1933
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Detroit, MI
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2391
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East Orange, NJ
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Egg Harbour Township, New Jersey 08234
2417
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Egg Harbour Township, NJ
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2313
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Fairfax, VA
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2424
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Farmington, CT
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Fayetteville, North Carolina 28304
2379
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Fayetteville, NC
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2429
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Hartford, CT
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1500
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Kansas City, KS
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1503
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Kansas City, MO
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872
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Las Vegas, NV
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1782
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Little Rock, AR
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2730
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Miami, FL
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2099
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New Orleans, LA
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2400
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New York, NY
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2429
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Norfolk, VA
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1366
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Omaha, NE
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2132
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Pittsburgh, PA
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147
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Portland, OR
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Poughkeepsie, NY
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1702
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Racine, WI
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2246
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Roanoke, VA
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626
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Sacramento, CA
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701
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Salt Lake City, UT
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1065
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San Diego, CA
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681
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San Francisco, CA
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694
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San Mateo, CA
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667
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San Rafael, CA
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1720
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St Louis, MO
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26
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Tacoma, WA
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2395
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from 98109
Vineland, NJ
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2686
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from 98109
Wellington, FL
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