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

Phase 4

• Conditions: Hepatitis B Virus Infection
• Interventions: Drug: Tenofovir Alafenamide

• Registration Number: NCT03695029
• Lead Sponsor: National Taiwan University Hospital

Brief Summary

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.

Detailed Description

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 Timeline

• Study Start: 2010-12-29
• Study First Submitted: 2018-09-20
• Study First Submitted QC: 2018-10-02
• Study First Posted: 2018-10-03
• Status Verified: 2020-11
• Last Update Submitted: 2020-11-25
• Last Update Posted: 2020-11-27
• Primary Completion: 2020-12-31
• Study Completion: 2021-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 120

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
treatment group	Tenofovir Alafenamide	Pregnant women receiving tenofovir alafenamide 25 mg per day since 26-32 weeks of pregnancy to 2-4 weeks postpartum.

Primary Outcome Measures

Name	Time	Method
Child HBsAg 6 mo	6 months after delivery	Serum status of HBsAg of the infants at 6 months old

Secondary Outcome Measures

Name	Time	Method
Maternal renal	6 and 12 months post delivery	Maternal serum creatinine (mg/dL) at 6 and 12 months post delivery
Materna bone marker	6 and 12 months post delivery	Maternal bone alkaline phosphatase (ug/L) at 6 and 12 months post delivery
Children's growth	6 and 12 months after birth	Children's growth: weight (kg) in Z score at 6 and 12 months after birth
Child HBsAg 12 mo	12 months after delivery	Serum status of HBsAg of the infants at 12 months old
Maternal ALT elevation	6 months after delivery	Rate of postpartum maternal ALT elevation above 2X upper limit of normal within 6 months after delivery
Maternal HBeAg-seroconverion	12 months after delivery	HBeAg-seroconversion rate within 12 months after delivery

Trial Locations

Locations (1)

National Taiwan University Hospital; 🇨🇳 Taipei, Taiwan