TEGSEDI Pregnancy Surveillance Program

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.