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:
2025-12-25 @ 3:30 AM
Ignite Modification Date:
2025-12-25 @ 3:30 AM
NCT ID:
NCT04211805
Eligibility Criteria:
Inclusion Criteria:
1. Pregnant female, above 18 years of age and under 40 years of age.
2. Gestational age between 12-14 weeks (The screening on patients can be started at gestational week 12).
3. Documented compensated and stable chronic hepatitis B defined by all of the following:
* HBsAg persistently positive \> 6 months.
* Clinical history, physical findings, and test results are compatible with compensated chronic hepatitis B.
4. Detectable maternal serum HBsAg and HBeAg at the screening visit.
5. Maternal serum HBV DNA levels exceeding 200,000 IU/mL by the COBAS Amplicor HBV PCR assay at screening visits.
6. Patient is willing and able to comply with the study drug regimen and all other study requirements. Patient is also willing to prevent another pregnancy in 28 weeks after delivery of the current baby.
7. Patient and her husband (both father and mother of the child) understand the risk and are willing to have the mother participating in the study. The mother must be willing and able to provide written informed consent to participate in the study.
Exclusion Criteria:
Patients will be excluded if they have any one of the following:
1. Creatinine clearance \<100 mL/min (using the Cockcroft-Gault method based on serum creatinine and ideal body weight) or hypo-phosphoremia (below normal range).
2. History of renal events on adefovir or history of resistance to adefovir.
3. Hemoglobin \<8 g/dL, or neutrophil count \<1000/uL, or ALT \>5 times ULN, or total bilirubin \>2 mg/dL; or albumin \<25gm/L, or abnormal creatinine level, or abnormal BUN levels.
4. History of abortion, or congenital malformation, or child infected with HBV in a prior pregnancy.
5. Biological father of the child (current pregnancy) has CHB.
6. Significant renal, cardiovascular, pulmonary, or neurological disease that may impact the subject's participation in the study as per the opinion of the investigator.
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Study:
NCT04211805
Study Brief:
Protocol Section:
NCT04211805