Trials / Not Yet Recruiting
Not Yet RecruitingNCT04270058
TEGSEDI Pregnancy Surveillance Program
Pregnancy Surveillance Program of Women and Infants Exposed to TEGSEDI During Pregnancy
- Status
- Not Yet Recruiting
- Phase
- —
- Study type
- Observational
- Enrollment
- 20 (estimated)
- Sponsor
- Akcea Therapeutics · Industry
- Sex
- Female
- Age
- —
- Healthy volunteers
- Not accepted
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
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | inotersen | TEGSEDI injection, for subcutaneous use |
Timeline
- Start date
- 2025-12-01
- Primary completion
- 2030-11-15
- Completion
- 2030-11-15
- First posted
- 2020-02-17
- Last updated
- 2025-08-19
Source: ClinicalTrials.gov record NCT04270058. Inclusion in this directory is not an endorsement.