Ignite Creation Date:
2024-05-05 @ 10:22 PM
Last Modification Date:
2024-10-26 @ 10:18 AM
Study NCT ID:
NCT01095835
Status:
COMPLETED
Last Update Posted:
2016-11-03
First Post:
2010-03-26
Brief Title:
A Study of Pegylated Interferon Alfa-2a and Lamivudine in Patients With HBeAg-Negative Chronic Hepatitis B Virus HBV
Sponsor:
Hoffmann-La Roche
Organization:
Hoffmann-La Roche
Study Overview
Official Title:
A Multicenter Randomized Controlled Study Comparing the Efficacy and Safety of 48 Weeks of 40kD Branched Pegylated Interferon Alfa-2a PEG-IFN RO 25-8310 Versus 96 Weeks of PEG-IFN Alone or in Combination With 100 mg Lamivudine for 48 Weeks in Patients With HBeAg-Negative Chronic Hepatitis B
Status:
COMPLETED
Status Verified Date:
2016-03
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 study will compare the efficacy and safety of 2 different durations of treatment with pegylated interferon PEG-IFN alfa-2a in participants with Hepatitis B e Antigen HBeAg-negative chronic hepatitis B virus HBV It will also compare PEG-IFN alfa 2a treatment alone and in combination with lamivudine LAM The anticipated time on study treatment is 1-2 years and the target sample size is 100-500 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