NCT04270058Not yet recruiting
TEGSEDI Pregnancy Surveillance Program
Pregnancy Surveillance Program of Women and Infants Exposed to TEGSEDI During Pregnancy
Source: ClinicalTrials.gov · Last updated 19 Aug 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Observational
- Enrollment
- 20 (estimated)
- First submitted
- 7 Feb 2020
- Start date
- Dec 2025
- Primary completion date
- 15 Nov 2030
- Lead sponsor
- Akcea Therapeutics
- Diseases
- Amyloidosis
- NCT number
- NCT04270058
What you commit to
- Study type: Observational
- Planned participants: 20
- From Dec 2025 to the primary completion date, 15 Nov 2030
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other
- None
Who the study is looking for
- TEGSEDI exposed patients (Cohort 1) meeting the following criteria will be eligible for study entry:
- Pregnancies exposed to at least 1 dose of TEGSEDI within 25 weeks prior to conception or during pregnancy.
- Able and willing to provide informed consent.
- Unexposed patients (Cohort 2) meeting the following criteria will be eligible for study entry:
- Have a diagnosis of hATTR-PN during pregnancy.
- Have not been exposed to TEGSEDI within 25 weeks prior to conception or during pregnancy.
- Able and willing to provide informed consent.
Sex: Female · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.