Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-25 @ 5:01 AM
Ignite Modification Date:
2025-12-25 @ 5:01 AM
NCT ID:
NCT00336518
Brief Summary:
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 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.
Study:
NCT00336518
Study Brief:
Protocol Section:
NCT00336518