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NOT YET RECRUITING
NCT04270058
TEGSEDI Pregnancy Surveillance Program
Sponsor: Akcea Therapeutics
View on ClinicalTrials.gov
Summary
This is a worldwide safety surveillance study of pregnancy outcomes in women with hATTR-PN who may have been exposed or were not exposed to TEGSEDI prior to or during the pregnancy and of pediatric outcomes up to 1 year of age.
Official title: Pregnancy Surveillance Program of Women and Infants Exposed to TEGSEDI During Pregnancy
Key Details
Gender
FEMALE
Age Range
Any - Any
Study Type
OBSERVATIONAL
Enrollment
20
Start Date
2025-12
Completion Date
2030-11-15
Last Updated
2025-08-19
Healthy Volunteers
No
Interventions
DRUG
inotersen
TEGSEDI injection, for subcutaneous use