drugset / Trial / NCT03468907

The Safety of Anti-viral Therapy in Preventing HBV MTCT in Pregnant Women After Discontinuation

NCT03468907

Phase 4 Completed 111 enrolled Third Affiliated Hospital, Sun Yat-Sen University
Non-randomizedParallel-groupOpen-labelPrevention

Summary

Mother-to-child transmission (MTCT) is the most common mode of perpetuating chronic hepatitis B virus (HBV) infection in endemic countries. Many studies have demonstrated antepartum anti-viral therapy (AVT) is a advisable option to reduce mother-to-child transmission and the risk of vaccination breakthrough in infants who received passive-active immunoprophylaxis. However, several controversies over antiviral treatment have not been resolved, that is, optimal duration, effect of postpartum therapy, and risk of postpartum alanine aminotransferase (ALT) flare after withdrawal. Will the risk of postpartum hepatitis flares increase after short-term AVT in late pregnancy for maternal HBV infection is discontinued? Is there any correlation between postpartum hepatitis flares and withdrawal time? Will the proportion of postpartum flares be reduced if extending the duration of AVT after delivery? There is an urgent need in this area. This study mainly investigated the safety of antiviral therapy in preventing HBV mother-to-child transmission in pregnant women after discontinuation.

Timeline

Start
2015-06-01
Primary completion
2017-12-31
Completion
2017-12-31

Drugs

EvaluationDrugModalityDoseRoute
Subject Telbivudine Small molecule 600 mg Oral
Subject Tenofovir disoproxil fumarate Small molecule 300 mg Oral