Ignite Creation Date:
2025-12-24 @ 5:46 PM
Ignite Modification Date:
2026-02-08 @ 4:05 AM
Study NCT ID:
NCT00939068
Status:
UNKNOWN
Last Update Posted:
2009-10-14
First Post:
2009-07-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy and Safety Study of Telbivudine to Prevent Perinatal Transmission
Sponsor:
Southeast University, China
Organization:
Study Overview
Official Title:
A Study of Efficacy and Safety of Telbivudine in Pregnancy for the Prevention of Perinatal Transmission of Hepatitis B Virus Infection
Status:
UNKNOWN
Status Verified Date:
2009-10
Last Known Status:
ENROLLING_BY_INVITATION
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:
The purpose of this study is to evaluate the efficacy and safety of Telbivudine in pregnancy for the prevention of HBV perinatal transmission in highly viraemic mothers.
Detailed Description:
In the present study, we evaluated the effect of telbivudine given during the second and third trimesters of pregnancy to highly viremic, HBV DNA-positive mothers on maternal HBV DNA and HBeAg levels prior to delivery and the rate of vertical transmission of HBV to infants who received passive-active immunoprophylaxis. Additionally, we investigated the timing of the administration of telbivudine on reducing the risk of perinatal transmission and the safety of telbivudine during pregnancy.
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?: