NCT06947356Recruiting
Comparison of TAF and TDF in Preventing Mother-to-Child Transmission of HBV in Pregnancies With High Viral Loads
A Multicenter, Prospective, Open-label, Non-inferiority Randomized Controlled Study on the Efficacy of Tenofovir Alafenamide Fumarate vs. Tenofovir Disoproxil Fumarate in Preventing Mother-to-Child Transmission of Hepatitis B Virus in Pregnant Women With High Viral Loads
Source: ClinicalTrials.gov · Last updated 7 May 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
The main objective of this study is to compare the mother-to-infant transmission rates of hepatitis B between pregnant women receiving treatment with tenofovir alafenamide and those receiving treatment with tenofovir disoproxil fumarate, after administering the hepatitis B vaccine and hepatitis B immunoglobulin to their infants at birth. Investigators define the mother-to-infant transmission rate of hepatitis B as the proportion of infants who are HBsAg positive and have serum HBV DNA \>20 IU/mL at 28 weeks of age among all live births in the experimental group. Additionally, this study will also compare the incidence of congenital defects/malformations in infants born to mothers treated with tenofovir alafenamide and tenofovir disoproxil fumarate during the perinatal period to assess drug safety.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 210 (estimated)
- First submitted
- 20 Apr 2025
- Start date
- 3 May 2025
- Primary completion date
- 1 May 2028
- Lead sponsor
- Guangzhou 8th People's Hospital
- Diseases
- Hepatitis B
- NCT number
- NCT06947356
What you commit to
- Study type: Interventional
- Planned participants: 210
- From 3 May 2025 to the primary completion date, 1 May 2028
- 10 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- History of adverse renal reactions induced by Adefovir or history of Adefovir resistance.
- Pregnant women with a history of miscarriage, history of giving birth to a child with congenital malformations, or history of fetal infection with hepatitis B virus.
- The biological father of the current pregnancy has chronic hepatitis B.
- The investigator assesses that the subject has significant kidney, cardiovascular, pulmonary, or neurological diseases that affect their participation in the study.
Lab values
- Creatinine clearance \< 100 mL/min (calculated using the Cockcroft-Gault method based on serum creatinine and ideal body weight), or hypophosphatemia (below normal range).
- Meeting one of the following criteria: hemoglobin \< 80 g/L, neutrophil count \< 1000/μL, ALT \> 5 times the upper limit of normal, total bilirubin \> 20 mg/L, albumin \< 25 g/L, abnormal levels of creatinine or urea nitrogen.
Who the study is looking for
- Pregnant women aged between 20 and 40 years old
- Pregnancy duration between 20 to 28 weeks (screening for eligible patients can start from the 20th week of gestation)
- Clinically diagnosed with compensated chronic hepatitis B, HBsAg positive for more than 6 months, with clinical history, signs, and test results consistent with compensated chronic hepatitis B
- HBsAg and HBeAg positive in maternal serum during screening
- PCR testing shows maternal serum HBV DNA levels exceeding 200,000 IU/mL
- Subjects voluntarily agree to undergo treatment according to the study design's drug treatment plan and all other research requirements, and patients consent to strictly avoid pregnancy within 28 weeks postpartum
- Patients and their husbands (the biological parents of the child) understand the risks and voluntarily participate in the study. The mother must participate voluntarily and sign a written informed consent document before participating in the study.
Age in the registry: 20 years to 40 years · Sex: Female · Does not accept healthy volunteers
Sites (10)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Beijing You'an Hospital, Capital Medical University Coordinator of this site? Confirm its status | Beijing | China | Not yet recruiting |
| Xiangya Hospital Central South University Coordinator of this site? Confirm its status | Changsha | China | Not yet recruiting |
| The Third Affiliated Hospital of Guangzhou Medical University Coordinator of this site? Confirm its status | Guangzhou | China | Not yet recruiting |
| Guangzhou Eighth People's Hospital, Guangzhou Medical University Coordinator of this site? Confirm its status | Guangzhou | China | Recruiting |
| Guangzhou Women and Children's medical center Coordinator of this site? Confirm its status | Guangzhou | China | Not yet recruiting |
| The Fifth Affiliated Hospital of Guangzhou Medical University, Guangzhou Coordinator of this site? Confirm its status | Guangzhou | China | Not yet recruiting |
| Shenzhen Baoan Women's and Children's Hospital Coordinator of this site? Confirm its status | Shenzhen | China | Not yet recruiting |
| Shijiazhuang Maternity & Child Healthcare Hospital Coordinator of this site? Confirm its status | Shijiazhuang | China | Not yet recruiting |
| The Fifth Hospital of Shijiazhuang Coordinator of this site? Confirm its status | Shijiazhuang | China | Not yet recruiting |
| The First Affiliated Hospital of Wenzhou Medical University Coordinator of this site? Confirm its status | Wenzhou | China | Not yet recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.