Preventing Mother-to-child Transmission of Hepatitis B Virus With Tenofovir Alafenamide (TAF) (NCT05177926) | Clinical Trial Compass
UnknownPhase 4
Preventing Mother-to-child Transmission of Hepatitis B Virus With Tenofovir Alafenamide (TAF)
China330 participantsStarted 2021-04-04
Plain-language summary
The purpose of this study is to evaluate the efficacy and safety of Tenofovir alafenamide (TAF) for prevention of mother-to-child transmission of hepatitis B virus among pregnant women with high level HBV DNA.
Who can participate
Age range20 Years – 35 Years
SexFEMALE
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Inclusion Criteria:
* Pregnant woman aged 20 to 35 years old
* 24-26 week of gestation
* HBsAg positive more than 6 months and HBeAg positive
* HBV DNA\> 200,000 IU/ml
* Informed consent is signed voluntarily by both husband and wife
* Good compliance and able to be followed up as planned
Exclusion Criteria:
* Mothers co-infected with HCV and HIV
* Evidence of decompensated cirrhosis and liver cancer
* Mothers had other organ lesions which would affect patient compliance and follow-up plan
* Mothers had history of spontaneous abortion or their children had birth defect or congenital malformation
* Mothers received antiviral therapy within 6 months
* Mothers had history of kidney injury, CCr \<50ml/min and urine protein test positive (\>300mg/L)
* Mothers had history of other chronic diseases and had to take immunomodulators, cytotoxic drugs or hormonal drugs during pregnancy
* The infants' biological fathers are infected with HBV
* Symptoms of threatened abortion during early pregnancy
* ALT \> 1×upper limit of normal (ULN), or TBIL ≥ 1×ULN or glomerular filtration rate (GFR) \< 90 ml/min, or Albumin (ALB) \< 25 g/L
* Fetal malformations detected by B-ultrasound during pregnancy
* Participating in other studies
What they're measuring
1
Rate of mother-to-child transmission of HBV
Timeframe: from enrollment to the last infant completes post vaccination serological test (PVST), assessed up to 32 months
Trial details
NCT IDNCT05177926
SponsorNanfang Hospital, Southern Medical University