Using tenofovir alafenamide (TAF) in pregnancy to prevent mother-to-child hepatitis B transmission
Official title: Study to Evaluate the Pharmacokinetic, Safety, and Efficacy of TAF in HBV-Infected Pregnant Women
Run by First People's Hospital of Hangzhou · NCT05853718 · Data updated 2026-11-12
This study will try giving tenofovir alafenamide (TAF) to pregnant women with high hepatitis B viral loads to see if it safely lowers virus levels and prevents passing HBV to their babies.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Ages | 20 Years to 40 Years |
| Sex | Women only |
| Enrollment | 50 (estimated) |
| Sponsor | First People's Hospital of Hangzhou Academic / other |
| Locations | 1 site (Hangzhou, Zhejiang) |
| Status | Recruiting |
| Started | May 6, 2021 |
| Main results expected | December 30, 2025 |
| Study ends | December 30, 2025 |
| Registry record updated | September 8, 2025 |
| Trial ID | NCT05853718 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Pregnant women aged 20–40 who are HBsAg and HBeAg positive with HBV DNA ≥200,000 IU/mL at 24–32 weeks and who are willing to take TAF and provide informed consent.
✕Probably not a fit
Women with HIV or hepatitis C coinfection, decompensated liver disease, significant kidney impairment, detected fetal malformations, or abnormal liver/kidney labs are excluded and unlikely to benefit from this protocol.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This prospective, open-label study will enroll 50 HBeAg-positive pregnant women with HBV DNA ≥2×10^5 IU/mL to receive TAF from 28–32 weeks' gestation until delivery at Hangzhou First People's Hospital. Intensive blood sampling in a subset will measure TAF and tenofovir (TFV) plasma concentrations for pharmacokinetic analysis, and daily breast milk samples will be collected for five days to measure drug transfer. Primary endpoints include pharmacokinetic parameters, rate of mother-to-child transmission, and congenital malformation rate; secondary endpoints include change in maternal HBV DNA at delivery, HBeAg clearance/seroconversion, and postpartum ALT flares. Safety monitoring and standard obstetric care are provided during treatment and delivery.
Why it matters
Potential benefit: If successful, TAF could offer an effective, lower-dose antiviral option in pregnancy that reduces tenofovir exposure while preventing mother-to-child HBV transmission.
How similar studies have gone: Oral tenofovir disoproxil fumarate (TDF) has proven effective at preventing mother-to-child HBV transmission, and TAF shows similar antiviral potency with lower systemic TFV exposure in nonpregnant populations, but pregnancy-specific data for TAF remain limited.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age of 20-40 years; Positive for hepatitis B surface antigen (HBsAg) and hepatitis B virus e antigen (HBeAg); HBV DNA level \>200 000 IU/mL during the 24th-32nd week of pregnancy; Willing to take TAF for mother-to-child blockade; Both husband and wife are willingly sign an informed consent. Exclusion Criteria: * Co-infected with hepatitis C or HIV, or other chronic diseases; History of spontaneous abortion or congenital malformation; Decompensated cirrhosis and liver cancer; History of kidney injury, CCr \<50ml/min and urine protein test positive (\>300mg/L); Fetal malformations detected by B-ultrasound during pregnancy; ALT \> 2×upper limit of normal (ULN); TBIL ≥ 1×ULN; Albumin (ALB) \< 25 g/L.
Where it's running
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Hangzhou First People's Hospital
Hangzhou, Zhejiang, China Recruiting
Study contacts
- Principal investigator: Zhiyuan Ma, PhD — First People's Hospital of Hangzhou
- Study coordinator: Jie Jin, MD
- Email: jinjie0429@163.com
- Phone: 13372517879
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.