Study of Tenofovir Alafenamide in HBV-Infected Pregnant Women
Recruiting · NCT05853718 · Interventional (participants receive a specific treatment) · Lead sponsor: First People's Hospital of Hangzhou
View the official record on ClinicalTrials.gov →Interventions studied
Tenofovir Alafenamide Tablets
What this trial is about
The purpose of this study is to evaluate the pharmacokinetics, efficacy and safety of TAF in HBV-infected pregnant women.
Who can take part
Age range
20 Years to 40 Years
Sex
Female
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 4
Study type
Interventional (participants receive a specific treatment)
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.
Where it is running
1 location listed.
- Hangzhou First People's Hospital - Hangzhou, Zhejiang, China