A Non-interventional Cohort Safety Study of Patients With hATTR-PN

Overview

About this study

The purpose of this study with the Health Authorities from the United States (US), Canada and Europe, is to collect long-term safety information (including any potential side effects) for the drug TEGSEDI in patients with hATTR-PN under real-world conditions.

 

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria:

Either:

  • TEGSEDI Exposed Cohort: Patients diagnosed with hATTR-PN who have taken any dose of TEGSEDI within 25 weeks prior to enrollment; or
  • TEGSEDI Unexposed Cohort: Patients diagnosed with hATTR-PN who have not taken any dose of TEGSEDI within 25 weeks prior to enrollment and are eligible for TEGSEDI treatment per applicable product label.
  • Clinically managed in Canada, Europe, or the US.
  • Have provided appropriate written informed consent.

Exclusion Criteria:

  • None.

Eligibility last updated 12/2/21. Questions regarding updates should be directed to the study team contact.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status

Rochester, Minn.

Mayo Clinic principal investigator

Michelle Mauermann, M.D.

Closed for enrollment

More information

Publications

Publications are currently not available

Additional contact information

Non-cancer trials contact form

Phone: 800-664-4542 (toll-free)

International patient clinical studies questions