The goal of this clinical trial is to study the efficacy and safety of Tenofovir alafenamide (TAF) vs Tenofovir disoproxil fumarate(TDF) in early and middle pregnancy with chronic hepatitis B.
The goal of this clinical trial is to study the efficacy and safety of Tenofovir alafenamide (TAF) vs Tenofovir disoproxil fumarate(TDF) in early and middle pregnancy with chronic hepatitis B. Previous studies have found that TAF has good clinical efficacy in the treatment of antiviral therapy in patients with chronic hepatitis B. In order to evaluate the clinical efficacy of TAF after antiviral therapy in pregnant women with chronic hepatitis B in the first and second trimesters, the clinical efficacy of TAF after antiviral therapy was evaluated by comparing the safety (including changes in maternal ALT, bilirubin, creatinine, blood phosphorus, blood lipids, fetal malformation rate, neonatal birth defects, head circumference, height, weight, intelligence and other indicators) and effectiveness (viral load decrease, serological conversion, mother-to-fetal blockade, etc.) with the TDF group.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
816
The Third Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangdong, China
To assess the incidence of ALT above normal (>=1 time) of mother
From the time of initiation of antiviral and normal ALT until delivery
Time frame: not more than 48 weeks
To assess the level of HBV-DNA of baby
At birth; At 7 months of age
Time frame: not more than 7 months
To assess the level of HBV-DNA of mother
Every 4 weeks of pregnancy
Time frame: not more than 48 weeks
To assess the results of liver Ultrasound of mother
At the time of enrollment; During childbirth
Time frame: not more than 48 weeks
To assess the weight in kilograms of baby
At birth; At 7 months of age
Time frame: not more than 7 months
To assess the height in meters of baby
At birth; At 7 months of age
Time frame: not more than 7 months
The number of HBsAg positive of baby
At birth; At 7 months of age
Time frame: not more than 7 months
The number of HBeAg positive of baby
At birth; At 7 months of age
Time frame: not more than 7 months
The number of HBsAg positive of mother
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Every 4 weeks of pregnancy
Time frame: not more than 48 weeks
The number of HBeAg positive of mother
Every 4 weeks of pregnancy
Time frame: not more than 48 weeks
The rate of deformity
Fetal period
Time frame: not more than 48 weeks
The rate of Birth defect
At birth
Time frame: 1 day
The levels of creatinine of mother
From the time of initiation of antiviral until delivery
Time frame: not more than 48 weeks
The levels of blood lipids of mother
From the time of initiation of antiviral until delivery
Time frame: not more than 48 weeks