Comparison of TAF and TDF in Preventing Mother-to-Child Transmission of HBV in Pregnancies With High Viral Loads

NARecruitingINTERVENTIONAL
Enrollment

210

Participants

Timeline

Start Date

May 3, 2025

Primary Completion Date

May 1, 2028

Study Completion Date

May 1, 2028

Conditions
Hepatitis B
Interventions
DRUG

TAF group

Pregnant women will start TAF treatment (25 mg tablet taken orally once daily) from 28 weeks of gestation until delivery. After that, they will be randomly assigned to two subgroups among postpartum mothers without treatment indications: one subgroup will stop treatment, while the other subgroup will continue with an additional 12 weeks of TAF treatment. The mothers and their infants will be followed up at 28 weeks postpartum. Infants will receive the hepatitis B vaccine and HBIG within 12 hours after birth, as well as booster doses of the hepatitis B vaccine at 4 weeks and 24 weeks.

DRUG

TDF group

The mother will start receiving TDF treatment (300 mg tablet taken orally once daily) at 28 weeks of pregnancy until delivery. After that, mothers without treatment indications will be randomly assigned to two subgroups: one subgroup will stop treatment, while the other subgroup will receive an additional 12 weeks of TDF treatment. Infants will be vaccinated with the hepatitis B vaccine and HBIG within 12 hours after birth, as well as receive booster doses of the hepatitis B vaccine at 4 weeks and 24 weeks.

Trial Locations (10)

Unknown

RECRUITING

Guangzhou Eighth People's Hospital, Guangzhou Medical University, Guangzhou

NOT_YET_RECRUITING

Guangzhou Women and Children's Medical Center, Guangzhou

NOT_YET_RECRUITING

The Fifth Affiliated Hospital of Guangzhou Medical University, Guangzhou, Guangzhou

NOT_YET_RECRUITING

The Third Affiliated Hospital of Guangzhou Medical University, Guangzhou

NOT_YET_RECRUITING

Shenzhen Baoan Women's and Children's Hospital, Shenzhen

NOT_YET_RECRUITING

Shijiazhuang Maternity & Child Healthcare Hospital, Shijiazhuang

NOT_YET_RECRUITING

The Fifth Hospital of Shijiazhuang, Shijiazhuang

NOT_YET_RECRUITING

Xiangya Hospital, Central South University, Changsha

NOT_YET_RECRUITING

The First Affiliated Hospital of Wenzhou Medical University, Wenzhou

NOT_YET_RECRUITING

Beijing You 'an Hospital, Capital Medical University, Beijing

All Listed Sponsors
lead

Guangzhou 8th People's Hospital

OTHER