Hepatitis B Clinical Trial
Official title:
Prevention of Mother-to-child Transmission of Hepatitis B Virus (PMTCT-HBV): a One Arm, Open Label Intervention Study to Estimate the Optimal Timing of Tenofovir (TDF) in Pregnancy
Our goal is to determine the viral kinetics of HBV DNA reduction in 170 non-Thai pregnant
women receiving Tenofovir disoproxil fumarate (TDF) to inform a subsequent RCT. The
investigators also aim to determine adherence to daily TDF in pregnancy as new interventions
must not only be effective but also safe, feasible and acceptable in the local, and ideally
global, context.
Study Design: One arm, open label, Tenofovir treatment intervention study
Study Participants: Non-Thai pregnant women estimated gestation 12-20 weeks and their
offspring
Planned Sample Size: 170
Primary Objective To estimate the time to HBV DNA suppression (<100 IU/ml) in 170 HBV DNA
positive women who start TDF late in the first or early in the second trimester.
Outcome Measures Time in months to HBV DNA < 100 IU/ml
Secondary Objectives
1. To estimate the proportion of women with HBV DNA <100 IU/ml at delivery.
2. To estimate the TDF levels at delivery in women who are HBV DNA detectable and
undetectable.
3. To monitor safety of TDF in the Thailand-Myanmar border women
4. To address potential barriers to implementing TDF in early pregnancy to PMTCT-HBV.
5. To determine the rate of hepatic flares post-partum.
6. To estimate the proportion of cases of vertical transmission at 2 months of age.
7. Fetal growth monthly ultrasound, infant growth at 1,2,3,6,12 and neurodevelopment at 6
and 12 months
n/a
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