Study of Tenofovir Alafenamide in HBV-Infected Pregnant Women
Recruiting
Phase 4
Interventional Study
Chronic Hepatitis b
Tenofovir Alafenamide Fumarate
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 20 – 40
- Sex
- Female
- Trial phase
- Phase 4
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 50 (estimated)
- Sponsor
- First People's Hospital of Hangzhou · Other
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About This Trial
The purpose of this study is to evaluate the pharmacokinetics, efficacy and safety of TAF in HBV-infected pregnant women.
Trial Locations
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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 inf…
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