Status:
UNKNOWN
Tenofovir Alafenamide to Prevent Perinatal Transmission of Hepatitis B
Lead Sponsor:
The First Affiliated Hospital of Zhengzhou University
Collaborating Sponsors:
National Natural Science Foundation of China
Henan Provincial People's Hospital
Conditions:
Chronic Hepatitis B
Mother-to-Child Transmission
Eligibility:
FEMALE
20-40 years
Phase:
PHASE4
Brief 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 pr...
Detailed Description
The investigators intend to include 240 inactive chronic hepatitis B virus (HBV)-infected pregnant women who have an HBV DNA level higher than 200,000 IU per milliliter. Participants will be randomly ...
Eligibility Criteria
Inclusion
- Gestational age of more than 30 weeks;
- Had chronic hepatitis B virus (HBV) infection;
- HBV DNA \> 200,000 IU/ml;
- Consecutively normal levels of alanine aminotransferase (\< 40 U/L) and total bilirubin (\< 17.1 μmol/L);
- Willing and able to provide written informed consent and adhere to the trial protocol.
Exclusion
- Previous treatment to reduce alanine aminotransferase and total bilirubin levels;
- 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);
- Coinfection with hepatitis C, D, E, or human immunodeficiency virus;
- Previous or current evidence of hepatocellular carcinoma, cirrhosis, systemic or other organ disorders;
- A hemoglobin level of less than 80 g/L;
- A neutrophil count of less than 1.0 × 10\^9/L;
- An albumin level of less than 30 g/L;
- Clinical signs of threatened miscarriage;
- Evidence of fetal deformity by ultrasound examination and other tests;
- A history of abortion, pregnancy loss, or congenital malformation in a previous pregnancy;
- A history of genetic disease(s), including the family member(s);
- Concurrent treatment with other drugs, including but not limited to nephrotoxic drugs, immune modulators, cytotoxic drugs, nonsteroidal antiinflammatory drugs, or steroids.
Key Trial Info
Start Date :
April 26 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2022
Estimated Enrollment :
240 Patients enrolled
Trial Details
Trial ID
NCT04850950
Start Date
April 26 2021
End Date
December 31 2022
Last Update
April 23 2021
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