Ignite Creation Date:
2025-12-25 @ 5:01 AM
Ignite Modification Date:
2025-12-25 @ 5:01 AM
Study NCT ID:
NCT00336518
Status:
UNKNOWN
Last Update Posted:
2006-06-13
First Post:
2006-06-12
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Continuing Treatment With Pegasys and Copegus
Sponsor:
Májbetegekért Alapítvány
Organization:
Study Overview
Official Title:
Efficacy and Safety of Continuing for a Total of 48 or Prolonging for a Total of 72 Weeks of Combined Treatment of Patients Receiving Pegasys and Copegus Who Are Biochemical Responders But Virological Non-Responders at Week 12 or Week 24
Status:
UNKNOWN
Status Verified Date:
2005-08
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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.
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 Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?: