Actively Recruiting
A Non-interventional Cohort Safety Study of Patients With hATTR-PN
Led by Akcea Therapeutics · Updated on 2025-09-11
240
Participants Needed
26
Research Sites
757 weeks
Total Duration
On this page
Sponsors
A
Akcea Therapeutics
Lead Sponsor
U
United BioSource, LLC
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
A Non-interventional Cohort Safety Study of Patients With hATTR-PN
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients diagnosed with hATTR-PN who have taken any dose of TEGSEDI within 25 weeks prior to enrollment OR patients diagnosed with hATTR-PN who have not taken TEGSEDI within 25 weeks prior to enrollment and are eligible for TEGSEDI treatment per product label
- Clinically managed in Canada, Europe, or the US
- Have provided appropriate written informed consent
You will not qualify if you...
History of severe allergic reactions to study medication Currently pregnant or breastfeeding Recent participation in another clinical trial within the last 30 days Presence of uncontrolled medical conditions that could affect safety
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 26 locations
1
Study Centre
Sofia, Bulgaria, 1431
Actively Recruiting
2
Study Centre
Égkomi, Nicosia, Cyprus, 2371
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3
Study Center
Lille, Cedex, France, 59037
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4
Study Center
Nice, Romaine, France, 06001
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5
Study Centre
Nantes, France, 44093
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6
Study Center
Heidelberg, Germany, 69120
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7
Study Center
Athens, Greece, 115 28
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8
Study Center
Athens, Greece, 11528
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9
Study Center
Heraklion, Greece, 71500
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10
Study Centre
Roma, Rome, Italy, 00189
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11
Study Center
Bologna, Italy, 40139
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12
Study Center
Genova, Italy, 16132
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13
Study Center
Messina, Italy, 98125
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14
Study Center
Milan, Italy, 20133
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15
Study Center
Naples, Italy, 80131
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16
Study Center
Pavia, Italy, 27100
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17
Study Center
Roma, Italy, 00133
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18
Study Center
Roma, Italy, 00168
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19
Study Center
Lisbon, Portugal, 1649 035
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20
Study Center
Huelva, Andalusia, Spain, 21005
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21
Study Centre
Oviedo, Avenida de Roma, Spain, 33011
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22
Study Center
Palma de Mallorca, Balearic Islands, Spain, 07198
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23
Study Centre
Villarreal, Barcelona, Spain, 08036
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24
Study Centre
Barcelona, Catalonia, Spain, 08035
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25
Study Centre
Madrid, Madrid, Spain, 28040
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26
Study Center
Madrid, Spain, 28041
Actively Recruiting
Research Team
I
Ionis Pharmaceuticals
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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