Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 4:47 PM
Ignite Modification Date:
2025-12-24 @ 4:47 PM
NCT ID:
NCT04850950
Eligibility 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.
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
20 Years
Maximum Age:
40 Years
Study:
NCT04850950
Study Brief:
Protocol Section:
NCT04850950