Efficacy and Safety Study of Telbivudine to Prevent Perinatal Transmission

Phase 4 Unknown 180 enrolled Southeast University, China

Non-randomizedParallel-groupOpen-labelTreatment

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.

Timeline

Start: 2008-02
Primary completion: 2010-07
Completion: 2010-11

Publications

Han GR, Jiang HX, Wang CM, Ding Y, Wang GJ, Yue X, Zhou L, Zhao W. Long-term safety and efficacy of telbivudine in infants born to mothers treated during the second or third trimesters of pregnancy. J Viral Hepat. 2017 Jun;24(6):514-521. doi: 10.1111/jvh.12670. Epub 2017 Feb 14.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Telbivudine	Small molecule	600 mg	Oral
Background	engineered HB vaccine	Vaccine	20 ug	Other

Efficacy and Safety Study of Telbivudine to Prevent Perinatal Transmission

Summary

Timeline

Publications

Drugs

Indications