Tenofovir Alafenamide to Prevent Perinatal Transmission of Hepatitis B
TAF-PPT
Safety and Efficacy of Tenofovir Alafenamide to Prevent Perinatal Transmission of Hepatitis B (TAF-PPT): A Multicentre, Prospective, Open-label, Randomized Controlled Trial
1 other identifier
interventional
240
0 countries
N/A
Brief Summary
To investigate the safety and efficacy of tenofovir alafenamide (orally 25 mg per day) treated in inactive chronic hepatitis B virus (HBV)-infected pregnant women with high viral load from the late pregnancy until the delivery date or postpartum 1 month.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Apr 2021
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 9, 2021
CompletedFirst Posted
Study publicly available on registry
April 20, 2021
CompletedStudy Start
First participant enrolled
April 26, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2022
CompletedApril 23, 2021
April 1, 2021
1.7 years
April 9, 2021
April 21, 2021
Conditions
Outcome Measures
Primary Outcomes (2)
Birth defects.
Structural defect in newborns or infants were reported as birth defects. The monitoring of birth defects was conducted by a clinical examination during each visit, and further clinical imaging or other tests were performed if indicated. The birth defect rate represented the proportion of infants with a defect among all live births.
From prenatal tenofovir alafenamide exposure to the birth and postnatal period up to 7 months of age.
The rate of perinatal transmission of hepatitis B virus.
The rate of perinatal transmission was defined as the proportion of infants who are positive for hepatitis B surface antigen at 7 months of age.
At 7 months of age.
Secondary Outcomes (6)
Adverse events.
From prenatal tenofovir alafenamide exposure to the delivery (birth) and postnatal period up to 7 months (of age).
Alanine aminotransferase flare.
At postpartum month 7.
Infants' growth.
At birth and 7 months of age.
HBV DNA level.
Immediately before or at delivery.
Hepatitis B e antigen status.
At postpartum month 7.
- +1 more secondary outcomes
Study Arms (2)
Arm 1
EXPERIMENTALTenofovir alafenamide fumarate discontinued at delivery date.
Arm 2
EXPERIMENTALTenofovir alafenamide fumarate discontinued at postpartum month 1.
Interventions
Tenofovir alafenamide fumarate initiated from the late pregnancy to the delivery date or postpartum month 1.
Eligibility Criteria
You may qualify if:
- Gestational age of more than 30 weeks;
- Had chronic hepatitis B virus (HBV) infection;
- HBV DNA \> 200,000 IU/ml;
- Consecutively normal levels of alanine aminotransferase (\< 40 U/L) and total bilirubin (\< 17.1 μmol/L);
- Willing and able to provide written informed consent and adhere to the trial protocol.
You may not qualify if:
- Previous treatment to reduce alanine aminotransferase and total bilirubin levels;
- Previous antiviral treatment for HBV infection (except when antiviral agents were administered for the prevention of perinatal transmission during a previous pregnancy and discontinued more than 6 months before the current pregnancy);
- Coinfection with hepatitis C, D, E, or human immunodeficiency virus;
- Previous or current evidence of hepatocellular carcinoma, cirrhosis, systemic or other organ disorders;
- A hemoglobin level of less than 80 g/L;
- A neutrophil count of less than 1.0 × 10\^9/L;
- An albumin level of less than 30 g/L;
- Clinical signs of threatened miscarriage;
- Evidence of fetal deformity by ultrasound examination and other tests;
- A history of abortion, pregnancy loss, or congenital malformation in a previous pregnancy;
- A history of genetic disease(s), including the family member(s);
- Concurrent treatment with other drugs, including but not limited to nephrotoxic drugs, immune modulators, cytotoxic drugs, nonsteroidal antiinflammatory drugs, or steroids.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- The First Affiliated Hospital of Zhengzhou Universitylead
- National Natural Science Foundation of Chinacollaborator
- Henan Provincial People's Hospitalcollaborator
- The Sixth People's Hospital of Zhengzhoucollaborator
- The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical Schoolcollaborator
- Second Affiliated Hospital of Xi'an Jiaotong Universitycollaborator
- Shandong Provincial Hospitalcollaborator
- Luoyang Central Hospitalcollaborator
- First Affiliated Hospital of Nanyang Medical Collegecollaborator
- Sixth People's Hospital of Kaifengcollaborator
- Luohe Central Hospitalcollaborator
- Xinyang Central Hospitalcollaborator
- Yan'an University Affiliated Hospitalcollaborator
- Nanyang Central Hospitalcollaborator
- Fifth People's Hospital of Anyangcollaborator
Related Publications (1)
Zeng QL, Zhou YH, Dong XP, Zhang JY, Li GM, Xu JH, Chen ZM, Song N, Zhang HX, Chen RY, Lv XY, Huang S, Li WZ, Pan YJ, Feng YH, Li ZQ, Zhang GF, Lin WB, Zhang GQ, Li GT, Li W, Zeng YL, Zhang DW, Cui GL, Lv J, Liu YM, Liang HX, Sun CY, Wang FS, Yu ZJ. Expected 8-Week Prenatal vs 12-Week Perinatal Tenofovir Alafenamide Prophylaxis to Prevent Mother-to-Child Transmission of Hepatitis B Virus: A Multicenter, Prospective, Open-Label, Randomized Controlled Trial. Am J Gastroenterol. 2025 May 1;120(5):1045-1056. doi: 10.14309/ajg.0000000000003122. Epub 2024 Oct 9.
PMID: 39382852DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Qing-Lei Zeng
The First Affiliated Hospital of Zhengzhou University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor
Study Record Dates
First Submitted
April 9, 2021
First Posted
April 20, 2021
Study Start
April 26, 2021
Primary Completion
December 31, 2022
Study Completion
December 31, 2022
Last Updated
April 23, 2021
Record last verified: 2021-04