TEGSEDI Pregnancy Surveillance Program
NCT04270058 · Status: NOT_YET_RECRUITING · Type: OBSERVATIONAL · Enrollment: 20
Last updated 2025-08-19
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.
Conditions
- Hereditary Transthyretin-mediated Amyloidosis With Polyneropathy
- Pregnancy
Interventions
- DRUG
-
inotersen
TEGSEDI injection, for subcutaneous use
Sponsors & Collaborators
-
Akcea Therapeutics
lead INDUSTRY
Eligibility
- Sex
- FEMALE
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2025-12-31
- Primary Completion
- 2030-11-15
- Completion
- 2030-11-15
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