TEGSEDI Pregnancy Surveillance Program

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.

Conditions

Hereditary Transthyretin-mediated Amyloidosis With Polyneropathy, Pregnancy

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Study Overview

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Study Details

Study overview

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.

Pregnancy Surveillance Program of Women and Infants Exposed to TEGSEDI During Pregnancy

TEGSEDI Pregnancy Surveillance Program

Condition
Hereditary Transthyretin-mediated Amyloidosis With Polyneropathy
Intervention / Treatment

-

Contacts and Locations

Morgantown

TEGSEDI Pregnancy Coordinating Center, Morgantown, West Virginia, United States, 26508

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • 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.
  • 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.

Ages Eligible for Study

to

Sexes Eligible for Study

FEMALE

Accepts Healthy Volunteers

No

Collaborators and Investigators

Akcea Therapeutics,

Study Record Dates

2030-11-15