Study of Tenofovir Alafenamide Fumarate Tablets (TAF) in Blocking Mother-to-child Transmission of Hepatitis B Virus
A Prospective,Multi-center,Cohort Trial: the Efficacy and Safety of Tenofovir Alafenamide Fumarate Tablets (TAF) in Blocking Mother-to-child Transmission of Hepatitis B Virus(HBV)
1 other identifier
observational
330
1 country
1
Brief Summary
This study is a single-group, multi-center and prospective clinical study designed to assess the efficacy and safety of TAF in blocking mother-to-child transmission of hepatitis B virus.Pregnant women whose HBsAg and HBeAg are positive are included in the study.Eligible hepatitis B pregnant women are given TAF antiviral therapy at 24-28 weeks of gestation to block mother-to-child transmission and followed up during pregnancy and after delivery.The study will be initiated with approval by the central ethics committee.Subjects will start screening after signing the informed consent form. Those who meet the criteria will start taking TAF (25mg, oral, 1/day) at 24-28 weeks of gestation until one month after delivery.At that time, chronic hepatitis B carrier will stop taking antiviral therapy, and patients with chronic hepatitis B decide whether to continue the therapy according to the patient's condition.The babies born are immunized according to the national standard immunization program,, that is, 100 IU of hepatitis B immunoglobulin (HBIG) and 10 μg/0.5 ml of hepatitis B vaccine are given within 12 hours after birth. And the same dose of hepatitis B vaccine is given at 1 month and 6 months of age.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Aug 2019
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2019
CompletedFirst Submitted
Initial submission to the registry
August 18, 2019
CompletedFirst Posted
Study publicly available on registry
August 22, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2021
CompletedAugust 22, 2019
August 1, 2019
2 years
August 18, 2019
August 20, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
MTCT rates in the TAF treated mothers
detectable levels of HBV DNA or HBsAg in the peripheral serum samples of infants at age 28 weeks
28 weeks post-partum
Study Arms (1)
TAF antiviral therapy group
Interventions
Eligible hepatitis B pregnant women are given TAF antiviral therapy (25mg, oral, 1/day) at 24-28 weeks of gestation until one month after delivery.
Eligibility Criteria
Pregnant women in the Affiliated Nanjing Hospital of Nanjing University of Chinese Medicine (The Second Hospital of Nanjing) whose HBsAg and HBeAg are positive are enrolled in the study. TAF is used as antiviral therapy during 24-28 week of gestation.The safety and efficacy of TAF are evaluated.
You may qualify if:
- maternal age: 20 to 35 years
- week of gestation
- HBsAg-positive more than 6 months and HBeAg-positive
- HBV DNA\> 1000,000 IU/ml
- both husband and wife voluntarily sign informed consent
- with good compliance and comply with follow-up programs
You may not qualify if:
- mother with co-infection of hepatitis C virus,human immunodeficiency virus
- evidence of decompensated liver disease
- combined with important organ lesions which will affect patient compliance and follow-up plans, pregnant women who are expected to be difficult to complete the study
- have a history of spontaneous abortion, or have a birth defect or congenital malformation in the last pregnancy
- mother treated with antiviral therapy within 6 months prior to enrollment(except those treated with antiviral therapy in the last pregnancy to prevent mother-to-child transmission)
- have a history of kidney injury, creatinine clearance \<50ml/min, urine protein positive (\>300mg/L)
- combined with other chronic diseases and need to take immunomodulators, cytotoxic drugs or hormonal drugs during pregnancy
- the infants' biologic father is a chronic HBV infected person
- symptoms of threatened abortion during early pregnancy
- evidence of hepatic cell carcinoma
- alanine aminotransferase (ALT) \> 10 x upper limit of normal(ULN ), or total bilirubin (TBIL) \> 3 x ULN or glomerular filtration rate (GFR) \< 90 mL (min\*1.73 m2), or serum Albumin (ALB) \< 25 g/L before enrollment
- fetal malformations detected by B-ultrasound
- participants in other research
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
The Affiliated Nanjing Hospital of Nanjing University of Chinese Medicine (The Second Hospital of Nanjing)
Nanjing, Jiangsu, 210003, China
Related Publications (1)
Han G, Zhou G, Sun T, Luo X, Xu J, Chen C, Xu W, Jiang S, Wang C. Tenofovir alafenamide in blocking mother-to-child transmission of hepatitis B virus: a multi-center, prospective study. J Matern Fetal Neonatal Med. 2022 Dec;35(26):10551-10558. doi: 10.1080/14767058.2022.2134771. Epub 2022 Oct 17.
PMID: 36253882DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Target Duration
- 64 Weeks
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Director of Obstetrics and Gynecology
Study Record Dates
First Submitted
August 18, 2019
First Posted
August 22, 2019
Study Start
August 1, 2019
Primary Completion
August 1, 2021
Study Completion
August 1, 2021
Last Updated
August 22, 2019
Record last verified: 2019-08