Trial intelligence / Profile preview

TDF and Hepatitis B Vaccine Strategy for MTCT Prevention

NCT03476083Phase 4

Key facts

Status: Unknown
Start: Jun 2018
Primary completion: May 2021
Countries: 1
Modality: Small Molecules

Drugs: tenofovir disoproxil fumarate
Conditions: hepatitis B (HBV)

Overview

Phase 4, randomised, open-label trial of tenofovir disoproxil fumarate in hepatitis B (HBV) (2 arms). Primary endpoint: Proportion of infants infected with hepatitis B at 28 weeks. Status: unknown.

Design

2 arms

Study design: RandomizedOpen-label

Early TDF + No HBIg
TDF starting week 14-16. Infant gets Vaccine only.
Late TDF + HBIg
TDF starting week 28. Infant gets Vaccine + HBIg.

Who it enrols

HBeAg-positive pregnant women (20-35 years) with chronic Hepatitis B and high viral load (>200,000 IU/mL) at 12-14 weeks gestation. Excludes co-infections (HIV, HCV, etc.), renal dysfunction, and fetal deformities.

Endpoints

Primary

Proportion of infants infected with hepatitis B28 weeks

Secondary

Congenital defects and/or malformation rates28 weeks
Reduction of maternal HBV DNA levelsDelivery
Percentage of mothers with loss/seroconversion of HBsAg or HBeAgPostpartum week 28
Adverse events of both mothers and infantsPostpartum week 28
Percentage of mothers who discontinue TDF therapy due to adverse eventsDelivery

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