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Clinical trial

Study to Evaluate the Pharmacokinetic, Safety, and Efficacy of TAF in HBV-Infected Pregnant Women

ID
Name
IIT-20210825-0020-01
Description
The purpose of this study is to evaluate the pharmacokinetics, efficacy and safety of TAF in HBV-infected pregnant women.
Trial arms
Trial start
2021-05-06
Estimated PCD
2024-07-30
Trial end
2024-12-30
Status
Recruiting
Phase
Early phase I
Treatment
Tenofovir Alafenamide Tablets
Take 25mg TAF daily from week 28-32 of gestation until delivery
Arms:
TAF antiviral therapy group
Other names:
TAF
Size
50
Primary endpoint
Assessment on the pharmacokinetics of TAF and TFV in plasma of pregnant women
The day before delivery
Rate of mother-to-child transmission of HBV
During 7-12 months after birth
Rate of birth defect of infants
From the date of birth to age of 28 weeks
Eligibility criteria
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.
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 50, 'type': 'ESTIMATED'}}
Updated at
2023-05-11

1 organization

1 product

2 indications

Organization
First People's Hospital of Hangzhou
Product
Tenofovir Alafenamide
Indication
Chronic Hepatitis B
Indication
Tenofovir Alafenamide Fumarate