Ignite Creation Date:
2025-12-24 @ 3:21 PM
Ignite Modification Date:
2026-01-06 @ 9:24 PM
Study NCT ID:
NCT01172392
Status:
UNKNOWN
Last Update Posted:
2013-03-29
First Post:
2010-07-28
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Randomized Study to Assess the Loss of HbsAg After a 48-week Treatment Period With Pegylated Interferon Alpha 2a in Patients With Chronic Hepatitis B
Sponsor:
ANRS, Emerging Infectious Diseases
Organization:
Study Overview
Official Title:
A Randomized, Multicenter, Unblinded, Phase III Study Assessing the Loss of HbsAg at W96 After a 48-week Pegylated Interferon Alpha 2a in Patients With Chronic Hepatitis B (HbeAg Negative) Under Treatment and Responders (Undetectable Viral Load) to a Nucleoside(s) or Nucleotide(s) Analog(s) Treatment for at Least 12 Months. ANRS HB 06 Pegan
Status:
UNKNOWN
Status Verified Date:
2013-02
Last Known Status:
ACTIVE_NOT_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:
PEGAN
Brief Summary:
The purpose of this study is to assess the loss of HbsAg after a 48-week pegylated interferon alpha 2a in patients with chronic hepatitis B (HBeAg negativation)
Detailed Description:
The purpose of this study is to provide a therapeutical alternative to the use of an extended or undeterminated duration of treatment with prolonged nucleoside (s)/nucleotide (s)analog (s).
The duration of administration is not consensual, and in most cases followed by a virological relapse, so that, the prolonged use could lead to the occurrence of viral resistance and mutations.
It is therefore expected that treatment with pegylated interferon for 48 weeks in patients with undetectable HBV DNA by analog(s) may increase and promotes the loss of HbsAg and then promotes HbsAg seroconversion. In the absence of cirrhosis, the loss of HbsAg at 6 months would allow the end of treatment
The duration of administration is not consensual, and in most cases followed by a virological relapse, so that, the prolonged use could lead to the occurrence of viral resistance and mutations.
It is therefore expected that treatment with pegylated interferon for 48 weeks in patients with undetectable HBV DNA by analog(s) may increase and promotes the loss of HbsAg and then promotes HbsAg seroconversion. In the absence of cirrhosis, the loss of HbsAg at 6 months would allow the end of treatment
Study Oversight
Has Oversight DMC:
True
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?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| ANRS HB 06 PEGAN | OTHER | FrenchAIDS | View |