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NCT04270058
Pregnancy Surveillance Program of Women and Infants Exposed to TEGSEDI During Pregnancy
trial testing inotersen in Hereditary Transthyretin-mediated Amyloidosis With Polyneropathy in 20 participants. Not yet recruiting.
15 November 2030
Quick facts
| Lead sponsor | Akcea Therapeutics |
|---|---|
| Status | Not yet recruiting |
| Study type | OBSERVATIONAL |
| Enrollment | 20 |
| Start date | 1 December 2025 |
| Primary completion | 15 November 2030 |
| Estimated completion | 15 November 2030 |
Drugs / interventions tested
- inotersen — full drug profile →
Conditions studied
- Hereditary Transthyretin-mediated Amyloidosis With Polyneropathy — all drugs for Hereditary Transthyretin-mediated Amyloidosis With Polyneropathy →
- Pregnancy — all drugs for Pregnancy →
Sponsor
Akcea Therapeutics — full company profile →
Who can join
Eligibility, female only, with Hereditary Transthyretin-mediated Amyloidosis With Polyneropathy or Pregnancy. Patients with the condition only — healthy volunteers not accepted.
What's being measured
Primary outcomes are the specific endpoints the trial is designed to prove or disprove.
-
Frequency of Selected Pregnancy and Fetal/Neonatal Outcomes
Time frame: 10 years or 12 months after the last live birth whichever is later
Estimate the frequency of selected pregnancy and fetal/neonatal outcomes through 1 year of age in women who were exposed to at least 1 dose of TEGSEDI (Cohort 1) within 25 weeks prior to conception or during pregnancy, with the exposure window of interest for major congenital malformations being the first trimester, and in the unexposed cohort of pregnant women (Cohort 2) who have a diagnosis of h -
Frequency of Selected Pregnancy Complications
Time frame: 10 years or 12 months after the last live birth whichever is later
Estimate the frequency of selected pregnancy complications in women who were exposed to TEGSEDI (Cohort 1) within 25 weeks prior to conception or during pregnancy and in the unexposed cohort of pregnant women (Cohort 2) who have a diagnosis of hATTR-PN
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT04270058
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Related trials
Other Akcea Therapeutics trials
Trials by the same sponsor.
- NCT04850105 — A Non-interventional Cohort Safety Study of Patients With hATTR-PN · recruiting
- NCT04306510 — A Study to Characterize Adverse Events Occurring Within One Day of TEGSEDI Administration to Adult Participants With hAT · Phase 4 · terminated
- NCT03514420 — Study of AKCEA-ANGPTL3-LRx (ISIS 703802) in Participants With Familial Partial Lipodystrophy (FPL) · Phase 2 · completed
- NCT03455777 — Study of AKCEA-ANGPTL3-LRX (ISIS 703802) in Patients With Homozygous Familial Hypercholesterolemia (HoFH) · Phase 2 · withdrawn
- NCT03506854 — Study of ISIS 681257 in Patients With Renal Impairment Compared to Healthy Patients · Phase 1 · completed
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04270058 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Akcea Therapeutics
- Last refreshed: 14 August 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04270058.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing