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

May 3, 2025 updated by: Calvin Q.Pan, Guangzhou 8th People's Hospital

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

see summary

Study Type

Interventional

Enrollment (Estimated)

210

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Calvin.Q Pan
  • Phone Number: +86 13632293277
  • Email: Panc01@nyu.edu

Study Locations

  • China
      • Beijing, China
        • Not yet recruiting
        • Beijing You 'an Hospital, Capital Medical University
        • Contact:
    • Guangdong
      • Guangzhou, Guangdong, China
        • Not yet recruiting
        • The Third Affiliated Hospital of Guangzhou Medical University
        • Contact:
      • Guangzhou, Guangdong, China
        • Not yet recruiting
        • Guangzhou Women and Children's Medical Center
        • Contact:
          • Yanmin Jiang
          • Phone Number: +86 020-38076169
      • Guangzhou, Guangdong, China
        • Recruiting
        • Guangzhou Eighth People's Hospital, Guangzhou Medical University
        • Contact:
      • Guangzhou, Guangdong, China
        • Not yet recruiting
        • The Fifth Affiliated Hospital of Guangzhou Medical University, Guangzhou
        • Contact:
      • Shenzhen, Guangdong, China
        • Not yet recruiting
        • Shenzhen Baoan Women's and Children's Hospital
        • Contact:
    • Hebei
      • Shijiazhuang, Hebei, China
        • Not yet recruiting
        • Shijiazhuang Maternity & Child Healthcare Hospital
        • Contact:
      • Shijiazhuang, Hebei, China
        • Not yet recruiting
        • The Fifth Hospital of Shijiazhuang
        • Contact:
    • Hunan
      • Changsha, Hunan, China
        • Not yet recruiting
        • Xiangya Hospital, Central South University
        • Contact:
    • Zhejiang
      • Wenzhou, Zhejiang, China
        • Not yet recruiting
        • The First Affiliated Hospital of Wenzhou Medical University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Pregnant women aged between 20 and 40 years old
  2. Pregnancy duration between 20 to 28 weeks (screening for eligible patients can start from the 20th week of gestation)
  3. Clinically diagnosed with compensated chronic hepatitis B, HBsAg positive for more than 6 months, with clinical history, signs, and test results consistent with compensated chronic hepatitis B
  4. HBsAg and HBeAg positive in maternal serum during screening
  5. PCR testing shows maternal serum HBV DNA levels exceeding 200,000 IU/mL
  6. Subjects voluntarily agree to undergo treatment according to the study design's drug treatment plan and all other research requirements, and patients consent to strictly avoid pregnancy within 28 weeks postpartum
  7. Patients and their husbands (the biological parents of the child) understand the risks and voluntarily participate in the study. The mother must participate voluntarily and sign a written informed consent document before participating in the study.

Exclusion Criteria:

  1. Creatinine clearance < 100 mL/min (calculated using the Cockcroft-Gault method based on serum creatinine and ideal body weight), or hypophosphatemia (below normal range).
  2. History of adverse renal reactions induced by Adefovir or history of Adefovir resistance.
  3. Meeting one of the following criteria: hemoglobin < 80 g/L, neutrophil count < 1000/μL, ALT > 5 times the upper limit of normal, total bilirubin > 20 mg/L, albumin < 25 g/L, abnormal levels of creatinine or urea nitrogen.
  4. Pregnant women with a history of miscarriage, history of giving birth to a child with congenital malformations, or history of fetal infection with hepatitis B virus.
  5. The biological father of the current pregnancy has chronic hepatitis B.
  6. The investigator assesses that the subject has significant kidney, cardiovascular, pulmonary, or neurological diseases that affect their participation in the study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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 HBV 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: 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.
Other Names:
  • TAF
Active Comparator: 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 HBV 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.
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.
Other Names:
  • TDF

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The mother-to-child transmission rate of HBV
Time Frame: 28 weeks
Compare the difference in HBV mother-to-infant transmission rates between pregnant women receiving TAF treatment and vaccinating their infants with hepatitis B vaccine and HBIg, and those receiving TDF treatment with the same vaccination for their infants. Here, the mother-to-infant transmission rate is defined as the proportion of infants in the experimental group who have serum HBV DNA >20 IU/mL and are HBsAg positive at 28 weeks of age among all live births.
28 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Congenital defects/malformations in infants
Time Frame: 28 weeks
Determine the incidence of congenital defects/malformations in infants born to mothers treated with TAF and TDF during the perinatal period, and then conduct a comparative analysis of these data.
28 weeks
The percentage of mothers in each group of pregnant women with HBV DNA below 200,000 IU/mL
Time Frame: 12 weeks
The percentage of mothers in each group of pregnant women with HBV DNA below 200,000 IU/mL at the time of delivery will be used as a key secondary efficacy endpoint to evaluate the extent of HBV DNA reduction in mothers receiving TDF/TAF treatment.
12 weeks
The percentage of mothers who experienced HBeAg/HBsAg clearance or seroconversion
Time Frame: 36 weeks
The percentage of mothers who experienced HBeAg/HBsAg clearance or seroconversion during the study period was used as a secondary efficacy endpoint, and comparisons were made between the two groups.
36 weeks
ALT levels during or after TDF/TAF treatment
Time Frame: 36 weeks
Observe the proportion of mothers with elevated ALT levels during or after TDF/TAF treatment (i.e., levels 5.1 to 10 times the upper limit of normal) or severe ALT elevation (levels more than 10 times the upper limit of normal), and conduct stratified and subgroup analyses after discontinuation of TDF/TAF (at delivery or at 12 weeks postpartum).
36 weeks
Renal function parameters of pregnant women
Time Frame: 36 weeks
Summarize the percentage changes in renal function parameters (especially the decline in renal function indicators) of pregnant women in each group during and after antiviral treatment, and analyze the differences between the two groups.
36 weeks
Adverse events (including obstetric complications and laboratory abnormalities)
Time Frame: 36 weeks
Summarize the percentage of mothers or infants experiencing adverse events (including obstetric complications and laboratory abnormalities) during the comparative study period, and analyze the differences between the two groups.
36 weeks
Proportion of two groups that discontinued treatment due to adverse events
Time Frame: 36 weeks
Summarize the comparison of the proportion of two groups that discontinued treatment due to adverse events, and evaluate the differences in tolerance and medication adherence to TDF/TAF therapy.
36 weeks
Health-related quality of life (HRQoL) indicators of pregnant women
Time Frame: 36 weeks
Use the 36-Item Short Form Health Survey (SF-36) to elucidate the differences in quality of life between pregnant women treated with Tenofovir Disoproxil Fumarate (TDF) and those receiving Tenofovir Alafenamide (TAF).The SF-36 scores range from 0 to 100, with higher scores indicating a better quality of life.
36 weeks
Health-related quality of life (HRQoL) indicators of pregnant women
Time Frame: 36 weeks
Use he Chronic Liver Disease Questionnaire (CLDQ) to elucidate the differences in quality of life between pregnant women treated with Tenofovir Disoproxil Fumarate (TDF) and those receiving Tenofovir Alafenamide (TAF). The CLDQ is scored between 29 and 203, where increased scores reflect improved well-being.
36 weeks
Health-related quality of life (HRQoL) indicators of pregnant women
Time Frame: 36 weeks
Use Patient Health Questionnaire-9 (PHQ-9) to elucidate the differences in quality of life between pregnant women treated with Tenofovir Disoproxil Fumarate (TDF) and those receiving Tenofovir Alafenamide (TAF). The PHQ-9 is scored from 0 to 27, with lower scores signifying a higher quality of life.
36 weeks

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
HBV DNA levels below 20 IU/mL
Time Frame: 12 weeks
Summarize the percentage difference in HBV DNA levels below 20 IU/mL during delivery between the two groups of pregnant women.
12 weeks
Placental abnormalities
Time Frame: 12 weeks
Evaluate and compare the percentage of mothers with placental abnormalities in the two groups.
12 weeks
Change in bone mineral density
Time Frame: 36 weeks
Evaluate the percentage of change (especially decline) in bone mineral density (BMD) among maternal groups during antiviral treatment and after the treatment ends.
36 weeks
Depression, MASLD, or liver fibrosis
Time Frame: 36 weeks
Evaluate the percentage of mothers with depression, MASLD, or liver fibrosis in each group before using TAF/TDF, during antiviral treatment, and after treatment.
36 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Guangzhou 8th People's Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 3, 2025

Primary Completion (Estimated)

May 1, 2028

Study Completion (Estimated)

May 1, 2028

Study Registration Dates

First Submitted

April 20, 2025

First Submitted That Met QC Criteria

April 20, 2025

First Posted (Actual)

April 27, 2025

Study Record Updates

Last Update Posted (Actual)

May 7, 2025

Last Update Submitted That Met QC Criteria

May 3, 2025

Last Verified

May 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • US-CN-P818

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

The investigators are committed to the responsible sharing of anonymized Individual Patient Data (IPD) with qualified external researchers upon request or as required by law and/or regulation, based on the following criteria:

  1. Nature of the Request: The specific details and objectives of the data request will be reviewed to ensure alignment with ethical standards and research integrity.
  2. Merit of the Proposed Research: The proposed research's potential scientific value and contribution to the broader scientific community will be evaluated. Priority will be given to research that addresses significant clinical or scientific questions.
  3. Availability of the Data: The feasibility of sharing the requested data, considering any technical, legal, or logistical constraints, will be assessed.
  4. Intended Use of the Data: The intended use of the data will be scrutinized to ensure it is appropriate

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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