TEGSEDI Pregnancy Surveillance Program

Launched by AKCEA THERAPEUTICS · Feb 12, 2020

Keywords

ClinConnect Summary

The TEGSEDI Pregnancy Surveillance Program is a study looking at the safety of pregnancy outcomes for women with a specific condition called hereditary transthyretin-mediated amyloidosis with polyneuropathy (hATTR-PN). This trial focuses on women who may have taken a medication called TEGSEDI before or during their pregnancy, as well as those who have not taken it at all. Researchers want to understand how both groups of women and their babies are affected, including following the babies' health for up to one year after birth.

To take part in this study, women must be pregnant and either have used TEGSEDI within 25 weeks before getting pregnant or during their pregnancy, or they must have a diagnosis of hATTR-PN but have not used the medication during that time. Participants will need to provide their consent to join the study. By joining, they can help researchers gather important information that could benefit future patients and their families. The study is currently recruiting participants, and there are no specific exclusion criteria, which means many women may be eligible to participate.

Gender

FEMALE

Eligibility criteria

• 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