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
610
mi
from
Chicago, IL
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522
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Austin, TX
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1148
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Baltimore, MD
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683
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Birmingham, AL
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1444
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Boston, MA
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1132
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Bradenton, FL
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1291
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Bronx, NY
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1438
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from
Burlington, MA
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972
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from
Columbia, SC
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349
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from
Dallas, TX
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841
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from
Detroit, MI
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1276
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from
East Orange, NJ
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Egg Harbour Township, New Jersey 08234
1252
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from
Egg Harbour Township, NJ
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1114
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Fairfax, VA
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1350
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from
Farmington, CT
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Fayetteville, North Carolina 28304
1067
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Fayetteville, NC
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1358
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Hartford, CT
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196
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Kansas City, KS
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198
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Kansas City, MO
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971
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Las Vegas, NV
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372
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from
Little Rock, AR
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1320
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from
Miami, FL
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697
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from
New Orleans, LA
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1290
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from
New York, NY
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1181
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from
Norfolk, VA
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262
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from
Omaha, NE
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971
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from
Pittsburgh, PA
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1383
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from
Portland, OR
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1294
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from
Poughkeepsie, NY
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630
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from
Racine, WI
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979
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from
Roanoke, VA
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1278
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from
Sacramento, CA
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779
mi
from
Salt Lake City, UT
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1143
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from
San Diego, CA
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1339
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from
San Francisco, CA
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1335
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San Mateo, CA
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1343
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San Rafael, CA
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418
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from
St Louis, MO
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Statesville, North Carolina 28677
945
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Statesville, NC
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1407
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from
Tacoma, WA
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1232
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from
Vineland, NJ
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1277
mi
from
Wellington, FL
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