Ignite Creation Date:
2024-05-05 @ 5:21 PM
Last Modification Date:
2024-10-26 @ 9:30 AM
Study NCT ID:
NCT00436163
Status:
COMPLETED
Last Update Posted:
2016-10-24
First Post:
2007-02-15
Brief Title:
A Study of Peginterferon Alfa-2a 40KD PEGASYS in Participants With Hepatitis B Envelope Antigen HBeAg - Positive Chronic Hepatitis B
Sponsor:
Hoffmann-La Roche
Organization:
Hoffmann-La Roche
Study Overview
Official Title:
Baltic Post-marketing Program of PEGASYS Peg Interferon Alpha-2a 40KD in Patients With HBeAg-positive and HBeAg-negative Chronic Hepatitis B
Status:
COMPLETED
Status Verified Date:
2016-08
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 single-arm study will evaluate the efficacy and safety of peginterferon alfa-2a in treatment-naive Baltic participants with Hepatitis B envelope antigen HBeAg-positive chronic Hepatitis B virus HBV All participants will receive peginterferon alfa-2a 180 micrograms mcg subcutaneously once weekly Following 48 weeks of treatment there will be a 24 week period of treatment-free follow-up The anticipated time on study treatment is 3-12 months and the target sample size is less than 100 participants
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