TEGSEDI Pregnancy Surveillance Program

Pregnancy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04270058
• Other study ID #: TEG4005
• Secondary ID: EUPAS41839
• Status: Recruiting
• Start date: January 15, 2020
• Est. completion date: November 15, 2030

Study information

• Verified date: April 2024
• Source: Akcea Therapeutics
• Contact: Ionis Pharmaceuticals
• Phone: (844) 962-4787
• Email: ionisNCT04270058study[@]clinicaltrialmedia.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: November 15, 2030
• Est. primary completion date: November 15, 2030
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Amyloidosis
• Hereditary Transthyretin-mediated Amyloidosis With Polyneropathy
• Pregnancy

Intervention

Drug:
• inotersen
TEGSEDI injection, for subcutaneous use

Locations

Country	Name	City	State
United States	TEGSEDI Pregnancy Coordinating Center	Morgantown	West Virginia

Sponsors (1)

Lead Sponsor	Collaborator
Akcea Therapeutics

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Frequency of Selected Pregnancy and Fetal/Neonatal Outcomes	Estimate the frequency of selected pregnancy and fetal/neonatal outcomes through 1 year of age in women who were exposed to at least 1 dose of TEGSEDI (Cohort 1) within 25 weeks prior to conception or during pregnancy, with the exposure window of interest for major congenital malformations being the first trimester, and in the unexposed cohort of pregnant women (Cohort 2) who have a diagnosis of hereditary transthyretin amyloidosis with polyneuropathy (hATTR-PN); pregnancy outcomes include live births, spontaneous abortions, stillbirths, elective abortions, preterm birth; fetal/neonatal outcomes include major and minor congenital malformations, small for gestational age, failure to thrive, and postnatal development	10 years or 12 months after the last live birth whichever is later
Primary	Frequency of Selected Pregnancy Complications	Estimate the frequency of selected pregnancy complications in women who were exposed to TEGSEDI (Cohort 1) within 25 weeks prior to conception or during pregnancy and in the unexposed cohort of pregnant women (Cohort 2) who have a diagnosis of hATTR-PN	10 years or 12 months after the last live birth whichever is later