Chronic Hepatitis b Clinical Trial
Official title:
Study to Evaluate the Pharmacokinetic, Safety, and Efficacy of TAF in HBV-Infected Pregnant Women
The purpose of this study is to evaluate the pharmacokinetics, efficacy and safety of TAF in HBV-infected pregnant women.
Status | Recruiting |
Enrollment | 50 |
Est. completion date | December 30, 2024 |
Est. primary completion date | July 30, 2024 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 20 Years to 40 Years |
Eligibility | Inclusion Criteria: - 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. Exclusion Criteria: - 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. |
Country | Name | City | State |
---|---|---|---|
China | Hangzhou First People's Hospital | Hangzhou | Zhejiang |
Lead Sponsor | Collaborator |
---|---|
First People's Hospital of Hangzhou |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | The day before delivery | |
Primary | Rate of mother-to-child transmission of HBV | Testing for HBsAg in the infants between 7 and 12 months of age. | During 7-12 months after birth | |
Primary | Rate of birth defect of infants | The proportion of infants with the aforementioned abnormalities discovered during the study period | From the date of birth to age of 28 weeks | |
Secondary | Reduction of HBV DNA levels at delivery | Reduction of HBV DNA levels (IU/mL) at delivery when compared to the baseline before initiating TAF | At delivery | |
Secondary | 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 | Immediately after breast milk is available and last for 5 days | |
Secondary | Concentrations of TAF and TFV in infant urine and plantar blood | Collect infant urine and plantar blood within 72 hours of birth | Within 72 hours of birth |
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