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TEGSEDI Pregnancy Surveillance Program

A

Akcea Therapeutics

Status

Enrolling

Conditions

Hereditary Transthyretin-mediated Amyloidosis With Polyneropathy
Pregnancy

Treatments

Drug: inotersen

Study type

Observational

Funder types

Industry

Identifiers

NCT04270058
EUPAS41839 (Other Identifier)
TEG4005

Details and patient eligibility

About

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.

Enrollment

20 estimated patients

Sex

Female

Volunteers

No Healthy Volunteers

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

Trial design

20 participants in 2 patient groups

Cohort 1
Description:
Cohort 1 will be pregnant patients who have been exposed to at least 1 dose of TEGSEDI within 25 weeks prior to conception or during pregnancy.
Treatment:
Drug: inotersen
Cohort 2
Description:
Cohort 2 will be pregnant patients who have hATTR-PN, who were not exposed to TEGSEDI or have not received TEGSEDI within the previous 25 weeks prior to conception.

Trial contacts and locations

1

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Central trial contact

Amy Miller, RPh, Pharm D.; Ionis Pharmaceuticals

Data sourced from clinicaltrials.gov

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