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 @ 12:14 AM
Ignite Modification Date:
2025-12-25 @ 12:14 AM
NCT ID:
NCT04270058
Eligibility Criteria:
Inclusion Criteria:
TEGSEDI exposed patients (Cohort 1) meeting the following criteria will be eligible for study entry:
1. Pregnancies exposed to at least 1 dose of TEGSEDI within 25 weeks prior to conception or during pregnancy.
2. Able and willing to provide informed consent.
Unexposed patients (Cohort 2) meeting the following criteria will be eligible for study entry:
1. Have a diagnosis of hATTR-PN during pregnancy.
2. Have not been exposed to TEGSEDI within 25 weeks prior to conception or during pregnancy.
3. Able and willing to provide informed consent.
Exclusion Criteria:
None
Healthy Volunteers:
False
Sex:
FEMALE
Study:
NCT04270058
Study Brief:
Protocol Section:
NCT04270058