Ignite Creation Date:
2024-05-05 @ 5:30 PM
Last Modification Date:
2024-10-26 @ 9:32 AM
Study NCT ID:
NCT00460850
Status:
TERMINATED
Last Update Posted:
2008-06-30
First Post:
2007-04-16
Brief Title:
A Study of PEGASYS Peginterferon Alfa-2a 40KD in Patients With Lamivudine Resistant HBeAg-Negative Chronic Hepatitis B
Sponsor:
Hoffmann-La Roche
Organization:
Hoffmann-La Roche
Study Overview
Official Title:
An Open Label Study to Evaluate the Effect of PEGASYS on ALT and HBV DNA Levels in Patients With Lamivudine-Resistant HbeAg-Negative Chronic Hepatitis B
Status:
TERMINATED
Status Verified Date:
2008-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Low recruitment rate due to treatment regimen change
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This single arm study will evaluate the efficacy and safety of PEGASYS in patients with lamivudine resistant HBeAg negative chronic hepatitis B Patients will receive PEGASYS 180 micrograms sc weekly for 48 weeks following this there will be a 48 week period of treatment-free follow-up The anticipated time on study treatment is 3-12 months and the target sample size is 100 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