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 @ 5:12 PM
Ignite Modification Date:
2025-12-24 @ 5:12 PM
NCT ID:
NCT02301650
Eligibility Criteria:
Inclusion Criteria:
* The one year old children whose mothers had taken Lamivudine,Telbivudine or Tenofovir in late pregnancy(28-30 weeks of gestation);
* The one year old children whose mothers untreated in late pregnancy;
* Children had completed standard hepatitis B vaccine and hepatitis B immune globulin combined active and passive prophylaxis;
* HBV DNA level of the children's mothers were over 6.0 log10 IU/ml before 28 weeks of gestation.
Exclusion Criteria:
* Children whose mothers over 35 years old at delivery;
* The couple having family hereditary disease or abnormal malformation has been found at fetal screening before 28 weeks gestation;
* History of amniocentesis during pregnancy;
* Co-infection with either hepatitis C virus, hepatitis D virus, human immunodeficiency virus, syphilis, toxoplasmosis, rubella or cytomegalovirus.
* Complications of pregnancy-induced hypertension, premature rupture of membranes, preterm birth, placenta previa or placental abruption; asphyxia at birth.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
1 Year
Maximum Age:
3 Years
Study:
NCT02301650
Study Brief:
Protocol Section:
NCT02301650