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A Study of PEGASYS (Peginterferon Alfa-2a (40KD)) With or Without Ribavirin in Patients With Chronic Hepatitis C Who Have Participated in Previous Roche or Roche Partner Protocols. - NCT00800735-85054(Clinical Trial 256959)



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City:  Phoenix
State:  
AZ
Zip Code: 85054
Conditions: Hepatitis C, Chronic
Purpose: This single arm study will provide treatment or re-treatment with PEGASYS as monotherapy or in combination with ribavirin (Copegus), to patients with chronic hepatitis C (CHC) who have participated in a previous Roche or Roche partner protocol where access to treatment or re-treatment was promised or deemed appropriate following completion of the original protocol ('donor' protocol). Patients who qualify for treatment or re-treatment will begin PEGASYS monotherapy,at a maximum dose of 180 micrograms weekly, or combination therapy with Copegus ,800-1200mg daily, as continuation of treatment after the wash-out period defined in their donor protocol. PEGASYS treatment is not to exceed approved treatment duration of 24 weeks in genotype 2/3 and 48 weeks in genotype non-2/3 with a treatment-free follow up period of 24 weeks. The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals.
Study summary:
Criteria: Inclusion Criteria: - adult patients, >=18 years of age; - CHC patients with compensated liver disease (Child-Pugh A) who have participated in a donor protocol where access to treatment or re-treatment with PEGASYS monotherapy or in combination with Copegus was promised or deemed appropriate after completion of the donor protocol. Exclusion Criteria: - evidence of decompensated liver disease (Child B or C cirrhosis).
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Data Source: ClinicalTrials.gov
Date Processed: January 20, 2010
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