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TEGSEDI Pregnancy Surveillance Program

StatusNot Yet Recruiting
PhaseNot specified
Started
View on ClinicalTrials.gov ↗

Record History

  1. Start date: Jan 15, 2020 to Dec 2025 Trial status: Recruiting to Not Yet Recruiting · Study sites: 1 to 0v9 Show 2 more changesShow less
    • Trial status: Recruiting to Not Yet Recruiting
    • Study sites: 1 to 0
  2. 2 versions Re-verified since Apr 11, 2024, no change to tracked fieldsv7-v8
  3. Start date changed from estimate of Dec 2023 to Jan 15, 2020v6
  4. Start date: Dec 31, 2021 to Dec 2023 Site details revisedv5 Show 1 more changeShow less
    • Site details revised
  5. Re-verified, no change to tracked fieldsv4
Show 2 earlier versionsHide 2 earlier versions
  1. Start date: Dec 31, 2020 to Dec 31, 2021v3
  2. Start date: Feb 17, 2020 to Dec 31, 2020v2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT04270058
Lead Sponsor Akcea Therapeutics
Conditions Hereditary Transthyretin-mediated Amyloidosis With Polyneropathy, Pregnancy
Enrollment 20 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov