Ignite Creation Date:
2024-05-05 @ 4:53 PM
Last Modification Date:
2024-10-26 @ 9:25 AM
Study NCT ID:
NCT00336518
Status:
UNKNOWN
Last Update Posted:
2006-06-13
First Post:
2006-06-12
Brief Title:
Continuing Treatment With Pegasys and Copegus
Sponsor:
Májbetegekért Alapítvány
Organization:
Májbetegekért Alapítvány
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 PegasysCopegus treatment
Secondary objective is to measure histological response given to continuation or prolongation of combined PegasysCopegus treatment measured by non-invasive methods
Secondary objective is to measure histological response given to continuation or prolongation of combined PegasysCopegus 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 PegasysCopegus combined therapy 180 mcgweek weightbased 1000-1200 mgday for a total of 48 weeks of treatment
P prolonged group PegasysCopegus combined therapy 180 mcgweek -weightbased 1000-1200 mgday 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 PegasysCopegus combined therapy 180 mcgweek weightbased 1000-1200 mgday for a total of 48 weeks of treatment
P prolonged group PegasysCopegus combined therapy 180 mcgweek -weightbased 1000-1200 mgday 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:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| EuDract 2005-004531-22 | None | None | None |
| ML 20142 | None | None | None |