EligibleTrials

Comparison of TAF and TDF in Preventing Mother-to-Child Transmission of HBV in Pregnancies With High Viral Loads

Recruiting · NCT06947356 · Interventional (participants receive a specific treatment) · Lead sponsor: Guangzhou 8th People's Hospital

View the official record on ClinicalTrials.gov →
Hepatitis B

Interventions studied

TAF groupTDF group

What this trial is about

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.

Who can take part

Age range
20 Years to 40 Years
Sex
Female
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)

Inclusion criteria

Exclusion criteria

Where it is running

10 locations listed.

Read the full protocol, contacts and eligibility on ClinicalTrials.gov →

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