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 @ 3:19 AM
Ignite Modification Date:
2025-12-25 @ 3:19 AM
NCT ID:
NCT02995005
Eligibility Criteria:
Inclusion Criteria:
* Pregnant women aged 18 and over
* HBsAg positive
* In the 12th-20th week of pregnancy
* Willing to take TDF daily during pregnancy
* Providing written informed consent
* Plans to deliver at Shoklo Malaria Research Unit (SMRU)
* Able and willing to comply with study requirements
Exclusion Criteria:
* Anti-HIV positive
* Negative qualitative HBV DNA if HBeAg negative
* On immunosuppressive therapy
* Elevated creatinine
* History of kidney disease
* Short cervix
* History of pregnancy complications or prior pre-term labor
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
16 Years
Maximum Age:
49 Years
Study:
NCT02995005
Study Brief:
Protocol Section:
NCT02995005