TEGSEDI Pregnancy Surveillance Program

RECRUITING

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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

🗓️ Study Start (Actual) 15 January 2020

🗓️ Primary Completion (Estimated) 15 November 2030

✅ Study Completion (Estimated) 15 November 2030

👥 Enrollment (Estimated) 20

🔬 Study Type OBSERVATIONAL

📊 Phase N/A

Locations:

📍 Morgantown, West Virginia, United States

📋 Eligibility Criteria

Description

Inclusion Criteria:

TEGSEDI exposed patients (Cohort 1) meeting the following criteria will be eligible for study entry:
1. Pregnancies exposed to at least 1 dose of TEGSEDI within 25 weeks prior to conception or during pregnancy.
2. Able and willing to provide informed consent.
Unexposed patients (Cohort 2) meeting the following criteria will be eligible for study entry:
1. Have a diagnosis of hATTR-PN during pregnancy.
2. Have not been exposed to TEGSEDI within 25 weeks prior to conception or during pregnancy.
3. Able and willing to provide informed consent.

Exclusion Criteria:

None

Ages Eligible for Study: N/A to N/A (CHILD, ADULT, OLDER_ADULT)

Sexes Eligible for Study: FEMALE

Accepts Healthy Volunteers: No

🗓️ Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

First Submitted 7 February 2020
First Submitted that Met QC Criteria 12 February 2020
First Posted 17 February 2020

Study Record Updates

Last Update Submitted that Met QC Criteria 11 April 2024
Last Update Posted 12 April 2024
Last Verified April 2024