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A Non-interventional Cohort Safety Study of Patients With hATTR-PN
Sponsor: Akcea Therapeutics
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.
Official title: A Prospective, Non-interventional, Long-term, Multinational Cohort Safety Study of Patients With Hereditary Transthyretin Amyloidosis With Polyneuropathy (hATTR-PN)
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
OBSERVATIONAL
Enrollment
240
Start Date
2021-09-21
Completion Date
2036-03-31
Last Updated
2025-09-11
Healthy Volunteers
No
Interventions
Data Collection
Data on each patient will be collected at study enrollment and at each follow-up visit. No mandatory visits, tests, or assessments are required for this study. All visits will be scheduled and conducted according to the clinical site's normal clinical practice.
Locations (26)
Study Centre
Sofia, Bulgaria
Study Centre
Égkomi, Nicosia, Cyprus
Study Center
Lille, Cedex, France
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Nice, Romaine, France
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Nantes, France
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Heidelberg, Germany
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Athens, Greece
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Athens, Greece
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Heraklion, Greece
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Roma, Rome, Italy
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Bologna, Italy
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Genova, Italy
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Messina, Italy
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Milan, Italy
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Naples, Italy
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Pavia, Italy
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Roma, Italy
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Roma, Italy
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Lisbon, Portugal
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Huelva, Andalusia, Spain
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Oviedo, Avenida de Roma, Spain
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Palma de Mallorca, Balearic Islands, Spain
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Villarreal, Barcelona, Spain
Study Centre
Barcelona, Catalonia, Spain
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Madrid, Madrid, Spain
Study Center
Madrid, Spain