Using Tenofovir Alafenamide to Prevent Hepatitis B Transmission from Mother to Child
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
The Third Affiliated Hospital of Guangzhou Medical University · NCT05466071
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 |
|---|---|
| Enrollment | 200 (estimated) |
| Ages | 20 Years to 40 Years |
| Sex | Female |
| Sponsor | The Third Affiliated Hospital of Guangzhou Medical University (other) |
| Locations | 1 site (Guangzhou, Guangdong) |
| Trial ID | NCT05466071 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Guangzhou, Guangdong
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Chronic Hepatitis b, Pregnancy Related, Tenofovir Alafenamide, Safety and Efficacy, Mother-to-Child Transmission, High HBV DNA Load