TAF vs TDF During the Pregancy

Phase 4Enrolling By InvitationNCT07542951

The Third Affiliated Hospital of Guangzhou Medical University200 enrolled

Overview

The goal of this clinical trial is to learn the efficacy and safety of Tenofovir alafenamide (TAF) vs Tenofovir disoproxil fumarate(TDF) in early and middle pregnancy antiviral therapy for chronic hepatitis B pregnant women. The main questions it aims to answer are: The rate of HBV mother-to-child transmission between the TAF and TDF groups. The incidence of birth defects in newborns between the TAF and TDF groups. What medical problems do participants have when taking drug TAF or TDF? The growth and development indices of newborns between the TAF and TDF groups. Participants will: Take drug TAF or TDF every day during the pregnacy. Visit the clinic once every 4 weeks for checkups and tests during the pregnancy and every 12 weeks postpartum.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

200

Conditions

Hepatitis B Virus Infection; Pregnant Women

Interventions

Eligibility

Sex: FEMALEMin age: 20 YearsMax age: 40 Years

Medical Language ↔ Plain English

Inclusion Criteria: Female gender. Age between 20-40 years old. Positive for HBsAg for ≥6 months. Pregnant at 0-24 weeks meeting the 2022 China Chronic Hepatitis B guidelines for antiviral therapy (including but not elevated transaminases, liver cirrhosis, hepatic fibrosis, or extrahepatic manifestations of hepatitis B). Willingness to take TAF/TDF orally once daily from enrollment until delivery or long-term use. Good medication compliance. Exclusion Criteria: Co-infection with hepatitis A, C, E viruses, other hepatotropic viruses, or HIV. Liver cirrhosis, liver cancer, or other chronic liver diseases. Significant organ diseases (e.g., heart, lung, or kidney diseases). Autoimmune hepatitis, autoimmune diseases, hypertension, diabetes, or thyroid disorders. History of pregnancy complications. History of fetal/neonatal growth defects in previous pregnancies. Use of nephrotoxic drugs, corticosteroids, NSAIDs, cytotoxic drugs, or immunomodulators prior to enrollment. Abnormal ultrasound findings indicating fetal malformations, placental abnormalities, or threatened miscarriage before treatment initiation. Failure to attend follow-up visits as scheduled. \-

Locations (1)

Department of Infectious Diseases, Guangdong Provincial Key Laboratory of Major Obstetric Diseases; Guangdong Provincial Clinical Research Center for Obstetrics and Gynecology, The Third Affiliated Hospital, Guangzhou Medical University,

Guangzhou, Guangdong, China

Outcomes

Primary Outcomes

Hepatitis B virus Mother-to-infant blocking rate

test HBsAg and HBV-DNA of the infants

Time frame: participant' infants 7 months old

Secondary Outcomes

Rate of birth defects

Time frame: When participants gave birth

Incidence of complications and adverse drug reactions during pregnancy

Time frame: From date of randomization until the date of first documented progression, assessed up to 14 months