drugset / Trial / NCT04850950
Tenofovir Alafenamide to Prevent Perinatal Transmission of Hepatitis B
Phase 4
Unknown
240 enrolled
The First Affiliated Hospital of Zhengzhou University
Fifth People's Hospital of Anyang · collabFirst Affiliated Hospital of Nanyang Medical College · collabHenan Provincial People's Hospital · collabLuohe Central Hospital · collabLuoyang Central Hospital · collabNanyang Central Hospital · collabNational Natural Science Foundation of China · collabSecond Affiliated Hospital of Xi'an Jiaotong University · collabShandong Provincial Hospital · collabSixth People's Hospital of Kaifeng · collabThe Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School · collabThe Sixth People's Hospital of Zhengzhou · collabXinyang Central Hospital · collabYan'an University Affiliated Hospital · collab
RandomizedParallel-groupOpen-labelPrevention
Summary
To investigate the safety and efficacy of tenofovir alafenamide (orally 25 mg per day) treated in inactive chronic hepatitis B virus (HBV)-infected pregnant women with high viral load from the late pregnancy until the delivery date or postpartum 1 month.
Timeline
- Start
- 2021-04-26
- Primary completion
- 2022-12-31
- Completion
- 2022-12-31
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | tenofovir alafenamide | Small molecule | 25 mg | Oral |