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

Active Not RecruitingN/A

Sponsor: Akcea Therapeutics

Conditions: Hereditary Transthyretin Amyloidosis With Polyneuropthy

Interventions: Data Collection

Countries: Bulgaria, Cyprus, France, Germany, Greece, Italy, Portugal, Spain

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 overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: OBSERVATIONAL

Eligibility criteria

Inclusion Criteria:

1. Either:

   1. TEGSEDI Exposed Cohort: Patients diagnosed with hATTR-PN who have taken any dose of TEGSEDI within 25 weeks prior to enrollment
   2. 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.
2. Clinically managed in Canada, Europe, or the US
3. Have provided appropriate written informed consent

Exclusion Criteria:

* None

Locations (26)

Sofia, Bulgaria
Égkomi, Nicosia, Cyprus
Lille, Cedex, France
Nice, Romaine, France
Nantes, France
Heidelberg, Germany
Athens, Greece
Athens, Greece
Heraklion, Greece
Roma, Rome, Italy
Bologna, Italy
Genova, Italy
Messina, Italy
Milan, Italy
Naples, Italy
Pavia, Italy
Roma, Italy
Roma, Italy
Lisbon, Portugal
Huelva, Andalusia, Spain
Oviedo, Avenida de Roma, Spain
Palma de Mallorca, Balearic Islands, Spain
Villarreal, Barcelona, Spain
Barcelona, Catalonia, Spain
Madrid, Madrid, Spain
Madrid, Spain