Using Tenofovir Alafenamide to Prevent Hepatitis B Transmission from Mother to Child
Official title: Safety and Efficacy of Tenofovir Alafenamide to Prevent Mother-to-child Transmission of Hepatitis B Virus in Middle/Late Pregnancies With High Hepatitis B Virus DNA Load: A Prospective Multicenter Cohort Study
Run by The Third Affiliated Hospital of Guangzhou Medical University · NCT05466071 · Data updated 2026-11-12
This study is testing if a new medication called Tenofovir Alafenamide can safely help pregnant women with Hepatitis B prevent passing the virus to their babies.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 20 Years to 40 Years |
| Sex | Women only |
| Enrollment | 200 (estimated) |
| Sponsor | The Third Affiliated Hospital of Guangzhou Medical University Academic / other |
| Locations | 1 site (Guangzhou, Guangdong) |
| Status | Recruiting |
| Started | June 1, 2021 |
| Main results expected | May 30, 2024 |
| Study ends | December 31, 2026 |
| Registry record updated | August 31, 2026 |
| Trial ID | NCT05466071 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are pregnant women aged 20-40 years with a high HBV DNA load of ≥2×10^5 IU/ml, who are in their 24-28 weeks of gestation.
✕Probably not a fit
Patients with concurrent chronic liver diseases, significant comorbidities, or those with a history of nucleoside analogues treatment may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational study investigates the safety and efficacy of Tenofovir Alafenamide (TAF) in preventing mother-to-child transmission (MTCT) of Hepatitis B virus (HBV) in pregnant women with high HBV DNA loads. The study focuses on women aged 20-40 years who are in their 24-28 weeks of gestation and have a positive HBsAg for at least six months. Participants will receive TAF or Tenofovir Disoproxil Fumarate (TDF) to assess the impact on reducing HBV transmission to infants. The study aims to address concerns regarding the side effects of TDF on infants while exploring a potentially safer alternative.
Why it matters
Potential benefit: If successful, this study could significantly reduce the risk of HBV transmission from mothers to their infants, improving health outcomes for newborns.
How similar studies have gone: Other studies have shown success with similar antiviral approaches in reducing MTCT of HBV, but the use of TAF specifically in this context is relatively novel.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age of 20-40 years. * Positive for HBsAg ≥6 months. * HBV DNA load of ≥ 2×10\^5 IU/ml. * Gestation 24-28 weeks . * Pregnancies are orally administrated with TAF (25mg/day) or TDF (300mg/day) from 24-28 weeks of gestation. * The good compliance of patients. Exclusion Criteria: * Patients with antibodies against HIV, HCV, HDV, or other forms of chronic liver disease. * Evidence of hepatocellular carcinoma, decompensated liver disease, auto-immune hepatitis, or significant renal, cardiovascular, respiratory or neurological comorbidity. * Concurrent treatment with nephrotoxic drugs, glucocorticoids, cytotoxic drugs, nonsteroidal anti-inflammatory drugs, or immune modulators. * Ultra-sonographic evidence of fetal deformity, abnormal fetal development or placental abnormality. * Clinical signs of threatened miscarriage. * History of complication of pregnancy. * History of nucleoside analogues (NA) treatment.
Where it's running
-
The Third Affiliated Hospital, Guangzhou Medical University
Guangzhou, Guangdong, China Recruiting
Study contacts
- Study coordinator: Bing Situ, Master
- Email: lilyst@126.com
- Phone: +86 20 81292050
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
Impact of functional cure on patient-reported outcomes in chronic hepatitis B
This study tests whether people with chronic hepatitis B who achieve a functional cure have better patient-reported outcomes compared to those not cured, relapse, or healthy controls.
-
Sequential combination therapy for functional cure of chronic hepatitis B
This trial tests a new two-drug approach to see if adding immunotherapy to ongoing HBV treatment can lead to loss of hepatitis B surface antigen in adults with chronic hepatitis B.
-
Combination therapy for functional cure in chronic hepatitis B
This phase 2 trial tests whether a sequence of anti-PD-1/PD-L1 antibodies with pegylated interferon and nucleos(t)ide analogues can achieve functional cure (HBsAg loss) in adults with chronic hepatitis B.
-
Prenatal education to reduce environmental exposures during pregnancy
Aimed at pregnant people, this program tests whether a classroom-style education can help reduce exposure to harmful pollutants from seafood and nearby pollution sources.
-
GST-HG131/GST-HG141 tablets vs placebo in chronic hepatitis B
A phase IIa trial tests GST-HG131 and GST-HG141 tablets against placebo to see if they are safe and help people with chronic hepatitis B.
-
Interprofessional Training to Improve Care for Peri-Delivery Patients with Substance Use Disorder
This program tests INSPIRE, a set of online and in-person trainings for healthcare teams to reduce stigma and improve care for people with substance use disorder around labor, delivery, and postpartum at the University of Utah.
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.