Ignite Creation Date:
2024-05-05 @ 5:19 PM
Last Modification Date:
2024-10-26 @ 9:30 AM
Study NCT ID:
NCT00435825
Status:
COMPLETED
Last Update Posted:
2013-06-25
First Post:
2007-02-15
Brief Title:
A Study of PEGASYS Peginterferon Alfa-2a 40KD in Patients With Hepatitis Be Antigen HBeAg Positive Chronic Hepatitis B CHB
Sponsor:
Hoffmann-La Roche
Organization:
Hoffmann-La Roche
Study Overview
Official Title:
A Randomized Double-blind Study of the Effect of Treatment Duration and Dose of PEGASYS on HBeAg Seroconversion and Safety in Patients With HBeAg Positive Chronic Hepatitis B
Status:
COMPLETED
Status Verified Date:
2013-06
Last Known Status:
None
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:
This 4 arm study will compare the efficacy and safety of PEGASYS given for 24 or 48 weeks and at doses of 90 or 180 micrograms weekly in the treatment of HBeAg positive patients with chronic hepatitis B Patients will be randomized to one of 4 treatment groups aPEGASYS 90 micrograms subcutaneous sc weekly for 24 weeks bPEGASYS 180 micrograms sc weekly for 24 weeks cPEGASYS 90 micrograms sc weekly for 48 weeks or dPEGASYS 180 micrograms sc weekly for 48 weeks Following treatment there will be a 24 week period of treatment-free follow-up in all treatment groups for the primary endpoint The anticipated time on study treatment is 3-12 months and the target sample size is 500 individuals
Detailed Description:
None
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