Study of Tenofovir Alafenamide in HBV-Infected Pregnant Women
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexFemale
Age20-40
SponsorFirst People's Hospital of Hangzhou
About this trial
The purpose of this study is to evaluate the pharmacokinetics, efficacy and safety of TAF in HBV-infected pregnant women.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age of 20-40 years; Positive for hepatitis B surface antigen (HBsAg) and hepatitis B virus e antigen (HBeAg); HBV DNA level >200 000 IU/mL during the 24th-32nd week of pregnancy; Willing to take TAF for mother-to-child blockade; Both husband and wife are willingly sign an informed consent.
Disqualifiers
Co-infected with hepatitis C or HIV, or other chronic diseases; History of spontaneous abortion or congenital malformation; Decompensated cirrhosis and liver cancer; History of kidney injury, CCr <50ml/min and urine protein test positive (>300mg/L); Fetal malformations detected by B-ultrasound during pregnancy; ALT > 2×upper limit of normal (ULN); TBIL ≥ 1×ULN; Albumin (ALB) < 25 g/L.
Trial design
Design model
Single group
Treatments tested in this trial
Tenofovir Alafenamide Tablets
DrugTake 25mg TAF daily from week 28-32 of gestation until delivery
Treatment groups
50 Participants
are divided into 1 treatment groupGroup A: TAF antiviral therapy groupExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Assessment on the pharmacokinetics of TAF and TFV in plasma of pregnant women
When taking the last TAF before delivery , 2ml of drug-containing blood was collected from the upper extremity veins at 0, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12 and 24h after taking TAF. Blood drug concentration at each time point was calculated according to standard curve.
Time frame
The day before delivery2
Rate of mother-to-child transmission of HBV
Testing for HBsAg in the infants between 7 and 12 months of age.
Time frame
During 7-12 months after birth3
Rate of birth defect of infants
The proportion of infants with the aforementioned abnormalities discovered during the study period
Time frame
From the date of birth to age of 28 weeksSecondary outcomes
1
Reduction of HBV DNA levels at delivery
Reduction of HBV DNA levels (IU/mL) at delivery when compared to the baseline before initiating TAF
Time frame
At delivery2
Drug concentration of TAF and TFV in breast milk after drug withdrawal
Postpartum breast milk was collected to measure TAF and TFV concentrations after drug withdrawal
Time frame
Immediately after breast milk is available and last for 5 days3
Concentrations of TAF and TFV in infant urine and plantar blood
Collect infant urine and plantar blood within 72 hours of birth
Time frame
Within 72 hours of birthSponsors and contacts
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Source ClinicalTrials.gov