A Prospective, Non-interventional, Long-term, Multinational Cohort Safety Study of Patients With Hereditary Transthyretin Amyloidosis With Polyneuropathy (hATTR-PN)
Status: Recruiting
Location: See all (25) locations...
Intervention Type: Other
Study Type: Observational
SUMMARY
This is a prospective, non-interventional, Long-term, multinational cohort safety study of patients with Hereditary Transthyretin Amyloidosis with Polyneuropathy (hATTR-PN). The overarching goal of this study is to further characterize the long-term safety of TEGSEDI (inotersen) in patients with hATTR-PN under real-world conditions.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• Either:
‣ TEGSEDI Exposed Cohort: Patients diagnosed with hATTR-PN who have taken any dose of TEGSEDI within 25 weeks prior to enrollment
⁃ 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. Patients may take other drugs to treat hATTR-PN.
• Clinically managed in Canada, Europe, or the US
• Have provided appropriate written informed consent
Locations
Other Locations
Bulgaria
Study Centre
RECRUITING
Sofia
Cyprus
Study Centre
RECRUITING
Égkomi
France
Study Center
RECRUITING
Lille
Study Centre
RECRUITING
Nantes
Study Center
RECRUITING
Nice
Germany
Study Center
RECRUITING
Heidelberg
Greece
Study Center
RECRUITING
Athens
Study Center
RECRUITING
Heraklion
Italy
Study Center
RECRUITING
Bologna
Study Center
RECRUITING
Genova
Study Center
RECRUITING
Messina
Study Center
RECRUITING
Milan
Study Center
RECRUITING
Napoli
Study Center
RECRUITING
Pavia
Study Center
RECRUITING
Roma
Study Center
RECRUITING
Roma
Study Centre
RECRUITING
Roma
Portugal
Study Center
RECRUITING
Lisbon
Spain
Study Centre
RECRUITING
Barcelona
Study Center
RECRUITING
Huelva
Study Center
RECRUITING
Madrid
Study Centre
RECRUITING
Madrid
Study Centre
RECRUITING
Oviedo
Study Center
RECRUITING
Palma De Mallorca
Study Centre
RECRUITING
Villarreal
Contact Information
Primary
Ionis Pharmaceuticals
ionisNCT04850105study@clinicaltrialmedia.com
(844) 915-5145
Time Frame
Start Date:2021-09-21
Estimated Completion Date:2036-03-31
Participants
Target number of participants:240
Treatments
TEGSEDI-exposed cohort
This cohort consist of patients diagnosed with hATTR-PN who are receiving any dose of commercial TEGSEDI and who have provided written informed consent to be included into the study.
TEGSEDI-unexposed cohort
This cohort which will consist of 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 and who have provided written informed consent to be included into the study.