REPEAT Study - A Study of PEGASYS (Peginterferon Alfa-2a (40KD)) Therapy in Combination With COPEGUS (Ribavirin) in Patients With Chronic Hepatitis C (CHC) Who Did Not Respond to Previous PegIntron (Peginterferon Alfa-2b (12KD))/Ribavirin Combination Therapy



Status:Completed
Conditions:Hepatitis, Hepatitis, Hepatitis
Therapuetic Areas:Immunology / Infectious Diseases
Healthy:No
Age Range:18 - Any
Updated:4/21/2016
Start Date:September 2003
End Date:May 2008

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A Randomized, Open-label Study of the Effect of PEGASYS Combined With Ribavirin on Sustained Virologic Response in Patients With Chronic Hepatitis C Who Did Not Respond to Previous Pegintron/Ribavirin Combination Therapy

This 4 arm study is designed for patients with CHC who have not responded to peginterferon
alfa-2b (12KD)/ribavirin combination therapy. In these patients, the effects of lengthening
the duration of treatment, as well as including an initial 12-week period of high-dose
PEGASYS (360 micrograms sc), are compared with the standard combination therapy of PEGASYS
(180 micrograms sc) and ribavirin (1000-1200mg po). The anticipated time on study treatment
is 1-2 years and the target sample size is 500+ individuals.


Inclusion Criteria:

- adult patients >=18 years of age;

- CHC infection;

- liver biopsy (in <24 calendar months of first dose), with results consistent with CHC
infection;

- use of 2 forms of contraception during study and 6 months after the study in both men
and women;

- Lack of response to previous treatment with peginterferon alfa-2b (12KD)/ribavirin
combination therapy given for >=12 weeks.

Exclusion Criteria:

- women who are pregnant or breastfeeding;

- male partners of women who are pregnant;

- conditions associated with decompensated liver disease;

- other forms of liver disease, including liver cancer;

- human immunodeficiency virus infection.
We found this trial at
34
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1064
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Williamsville, NY
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Albuquerque, NM
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Atlanta, GA
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Boston, MA
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Bradenton, FL
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Bruxelles,
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1356
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Burlington, VT
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610
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Chicago, IL
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1421
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Cranston, RI
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346
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Des Moines, IA
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Farmington, CT
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1266
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Florham Park, NJ
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Hollywood, FL
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569
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Houston, TX
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1053
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Jacksonville, FL
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198
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Kansas City, MO
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Lancaster, PA
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1168
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467
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Memphis, TN
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552
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Minneapolis, MN
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740
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Mobile, AL
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618
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Nashville, TN
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Pasadena, CA
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Philadelphia, PA
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1111
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Richmond, VA
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515
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Rochester, MN
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Salt Lake City, UT
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1026
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Savannah, GA
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843
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Scottsdale, AZ
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418
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St Louis, MO
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1372
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Ukiah, CA
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