Maternal Screening and Antiviral Therapy in Pregnant Women to Reduce Mother-to-infant Transmission of Hepatitis B Virus
1 other identifier
interventional
120
1 country
1
Brief Summary
To investigate the efficacy of using antiviral therapy in third trimester of pregnancy to reduce mother-to-infant HBV transmission, and to access the safety of such treatment for mothers and infants.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4
Started Dec 2010
Longer than P75 for phase_4
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
December 29, 2010
CompletedFirst Submitted
Initial submission to the registry
September 20, 2018
CompletedFirst Posted
Study publicly available on registry
October 3, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2021
CompletedNovember 27, 2020
November 1, 2020
10 years
September 20, 2018
November 25, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
Child HBsAg 6 mo
Serum status of HBsAg of the infants at 6 months old
6 months after delivery
Secondary Outcomes (7)
Child HBsAg 12 mo
12 months after delivery
Maternal ALT elevation
6 months after delivery
Maternal HBeAg-seroconverion
12 months after delivery
Maternal renal
6 and 12 months post delivery
Materna bone marker
6 and 12 months post delivery
- +2 more secondary outcomes
Study Arms (2)
treatment group
EXPERIMENTALPregnant women receiving tenofovir alafenamide 25 mg per day since 26-32 weeks of pregnancy to 2-4 weeks postpartum.
control group
NO INTERVENTIONcontrol group receive no drug, only follow-up
Interventions
Pregnant women receiving tenofovir alafenamide 25 mg per day since 26-32 weeks of pregnancy to 2-4 weeks postpartum.
Eligibility Criteria
You may qualify if:
- Women aged 20-45 years in 28 to 32 weeks of pregnancy
- Positive HBsAg and HBeAg
- Serum viral load above 6 log10 IU/mL
You may not qualify if:
- Major systemic disease of the mother or fetus
- Positive anti-HIV or anti-HCV
- Under treatment of antiviral therapy
- Pregnant woman whose ultrasonographic examination reveals congenital anomaly of the fetus
- Pregnant woman whose amniocentesis reveals any genetic abnormality
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
National Taiwan University Hospital
Taipei, 100, Taiwan
Related Publications (1)
Chen HL, Lee CN, Chang CH, Lai MW, Tsai MC, Mu SC, Liu CJ, Shih JC, Wen WH, Hu RT, Huang CP, Hu KC, Chen CP, Lee CL, Chien RN, Chang KC, Hsu HY, Lee CC, Ni YH, Chang MH. Tenofovir alafenamide or tenofovir disoproxil fumarate in pregnancy to prevent HBV transmission: Maternal ALT trajectory and infant outcomes. Liver Int. 2024 Jun;44(6):1422-1434. doi: 10.1111/liv.15873. Epub 2024 Mar 8.
PMID: 38456620DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 20, 2018
First Posted
October 3, 2018
Study Start
December 29, 2010
Primary Completion
December 31, 2020
Study Completion
December 31, 2021
Last Updated
November 27, 2020
Record last verified: 2020-11