Tenofovir Alafenamide to Prevent Perinatal Transmission of Hepatitis B

• Status: Not yet recruiting
• Trial end date: 2022-12-31
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: The First Affiliated Hospital of Zhengzhou University
• Collaborators: Fifth People's Hospital of Anyang; First Affiliated Hospital of Nanyang Medical College; Henan Provincial People's Hospital; Luohe Central Hospital; Luoyang Central Hospital; Nanyang Central Hospital; National Natural Science Foundation of China; Second Affiliated Hospital of Xi'an Jiaotong University; Shandong Provincial Hospital; Sixth People's Hospital of Kaifeng; The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School; The Sixth People's Hospital of Zhengzhou; Xinyang Central Hospital; Yan'an University Affiliated Hospital
• Treatments: Tenofovir

Criteria

Inclusion Criteria:

1. Gestational age of more than 30 weeks;

2. Had chronic hepatitis B virus (HBV) infection;

3. HBV DNA > 200,000 IU/ml;

4. Consecutively normal levels of alanine aminotransferase (< 40 U/L) and total bilirubin (< 17.1 μmol/L);

5. Willing and able to provide written informed consent and adhere to the trial protocol.

Exclusion Criteria:

1. Previous treatment to reduce alanine aminotransferase and total bilirubin levels;

2. Previous antiviral treatment for HBV infection (except when antiviral agents were administered for the prevention of perinatal transmission during a previous pregnancy and discontinued more than 6 months before the current pregnancy);

3. Coinfection with hepatitis C, D, E, or human immunodeficiency virus;

4. Previous or current evidence of hepatocellular carcinoma, cirrhosis, systemic or other organ disorders;

5. A hemoglobin level of less than 80 g/L;

6. A neutrophil count of less than 1.0 × 10^9/L;

7. An albumin level of less than 30 g/L;

8. Clinical signs of threatened miscarriage;

9. Evidence of fetal deformity by ultrasound examination and other tests;

10. A history of abortion, pregnancy loss, or congenital malformation in a previous pregnancy;

11. A history of genetic disease(s), including the family member(s);

12. Concurrent treatment with other drugs, including but not limited to nephrotoxic drugs, immune modulators, cytotoxic drugs, nonsteroidal antiinflammatory drugs, or steroids.