Last updated on June 2006

Continuing Treatment With Pegasys and Copegus


Brief description of study

Primary objective is to measure sustained viral response given to continuation or prolongation of combined Pegasys&Copegus treatment Secondary objective is to measure histological response given to continuation or prolongation of combined Pegasys&Copegus treatment measured by non-invasive methods

Detailed Study Description

Prospective, multicentre, randomized, open-label comparative study According to our national guideline of management of patient with chronic viral hepatitis, patients need to stop therapy if they do not achieve response. These patients can enter to the study at two time points: - at week 16, if HCV RNS PCR measured at week 12 is positive and serum ALT > 1ULN, but decreased - at week 28, if HCV RNS PCR measured at week 24 is still positive, but serum ALT < 2ULN. Patients are randomized to one of the following arms: - S (standard) group: Pegasys&Copegus combined therapy 180 mcg/week & weight/based 1000-1200 mg/day for a total of 48 weeks of treatment - P (prolonged) group: Pegasys&Copegus combined therapy 180 mcg/week & -weight/based 1000-1200 mg/day for a total of 72 weeks of treatment. After completing treatment period patients enter into a 24-week follow up.

Clinical Study Identifier: NCT00336518

Contact Investigators or Research Sites near you

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János Schuller, Dr.

Szt. L szl Hospital
Budapest, Hungary
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