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RECRUITING
NCT06947356
NA

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

Sponsor: Guangzhou 8th People's Hospital

View on ClinicalTrials.gov

Summary

The main objective of this study is to compare the mother-to-infant transmission rates of hepatitis B between pregnant women receiving treatment with tenofovir alafenamide and those receiving treatment with tenofovir disoproxil fumarate, after administering the hepatitis B vaccine and hepatitis B immunoglobulin to their infants at birth. Investigators define the mother-to-infant transmission rate of hepatitis B as the proportion of infants who are HBsAg positive and have serum HBV DNA \>20 IU/mL at 28 weeks of age among all live births in the experimental group. Additionally, this study will also compare the incidence of congenital defects/malformations in infants born to mothers treated with tenofovir alafenamide and tenofovir disoproxil fumarate during the perinatal period to assess drug safety.

Official title: A Multicenter, Prospective, Open-label, Non-inferiority Randomized Controlled Study on the Efficacy of Tenofovir Alafenamide Fumarate vs. Tenofovir Disoproxil Fumarate in Preventing Mother-to-Child Transmission of Hepatitis B Virus in Pregnant Women With High Viral Loads

Key Details

Gender

FEMALE

Age Range

20 Years - 40 Years

Study Type

INTERVENTIONAL

Enrollment

210

Start Date

2025-05-03

Completion Date

2028-05-01

Last Updated

2025-05-07

Healthy Volunteers

No

Conditions

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.

Locations (10)

Guangzhou Eighth People's Hospital, Guangzhou Medical University

Guangzhou, Guangdong, China

Guangzhou Women and Children's Medical Center

Guangzhou, Guangdong, China

The Fifth Affiliated Hospital of Guangzhou Medical University, Guangzhou

Guangzhou, Guangdong, China

The Third Affiliated Hospital of Guangzhou Medical University

Guangzhou, Guangdong, China

Shenzhen Baoan Women's and Children's Hospital

Shenzhen, Guangdong, China

Shijiazhuang Maternity & Child Healthcare Hospital

Shijiazhuang, Hebei, China

The Fifth Hospital of Shijiazhuang

Shijiazhuang, Hebei, China

Xiangya Hospital, Central South University

Changsha, Hunan, China

The First Affiliated Hospital of Wenzhou Medical University

Wenzhou, Zhejiang, China

Beijing You 'an Hospital, Capital Medical University

Beijing, China