Maternal Screening and Antiviral Therapy in Pregnant Women to Reduce Mother-to-infant Transmission of Hepatitis B Virus

National Taiwan University Hospital120 enrolled

Overview

To investigate the efficacy of using antiviral therapy in third trimester of pregnancy to reduce mother-to-infant HBV transmission, and to access the safety of such treatment for mothers and infants.

This is a multi-centered study conducted in 12-16 collaborative hospitals in Taiwan, using tenofovir as antiviral therapy to reduce mother-to-infant transmission. The study group recruited pregnant women at 2nd to 3rd trimester receive tenofovir disoproxil fumurate (TDF) 2011-2018, June, and receive tenofovir alafenamide (TAF) 2018-2021. Control group did not receive antiviral treatment. Both group receive mother and infant follow-up up to 12 months after delivery.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Enrollment

120

Conditions

Hepatitis B Virus Infection

Interventions

Tenofovir AlafenamideDRUG

Pregnant women receiving tenofovir alafenamide 25 mg per day since 26-32 weeks of pregnancy to 2-4 weeks postpartum.

Eligibility

Sex: FEMALEMin age: 20 YearsMax age: 40 Years

Medical Language ↔ Plain English

Inclusion criteria: * Women aged 20-45 years in 28 to 32 weeks of pregnancy * Positive HBsAg and HBeAg * Serum viral load above 6 log10 IU/mL Exclusion criteria: * Major systemic disease of the mother or fetus * Positive anti-HIV or anti-HCV * Under treatment of antiviral therapy * Pregnant woman whose ultrasonographic examination reveals congenital anomaly of the fetus * Pregnant woman whose amniocentesis reveals any genetic abnormality

Locations (1)

National Taiwan University Hospital

Taipei, Taiwan

RECRUITING

Outcomes

Primary Outcomes

Child HBsAg 6 mo

Serum status of HBsAg of the infants at 6 months old

Time frame: 6 months after delivery

Secondary Outcomes

Child HBsAg 12 mo

Serum status of HBsAg of the infants at 12 months old

Time frame: 12 months after delivery

Maternal ALT elevation

Rate of postpartum maternal ALT elevation above 2X upper limit of normal within 6 months after delivery

Time frame: 6 months after delivery

Maternal HBeAg-seroconverion

HBeAg-seroconversion rate within 12 months after delivery

Time frame: 12 months after delivery

Maternal renal

Maternal serum creatinine (mg/dL) at 6 and 12 months post delivery

Time frame: 6 and 12 months post delivery

Materna bone marker

Maternal bone alkaline phosphatase (ug/L) at 6 and 12 months post delivery

Time frame: 6 and 12 months post delivery

Children's growth

Children's growth: height (cm) in Z score at 6 and 12 months after birth

Time frame: 6 and 12 months after birth

Children's growth

Children's growth: weight (kg) in Z score at 6 and 12 months after birth

Time frame: 6 and 12 months after birth

Central Contacts

Mei-Hwei Chang

CONTACT

+886-2-23123456 changmh@ntu.edu.tw

Data from ClinicalTrials.gov

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