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NCT04850105
A Non-interventional Cohort Safety Study of Patients With hATTR-PN
Conditions: Hereditary Transthyretin Amyloidosis With Polyneuropthy
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Enrollment: 202
Sponsor: Akcea Therapeutics
Location: Study Centre Sofia
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 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
Source: ClinicalTrials.gov (NCT04850105). StuddyBuddy aggregates publicly available trial information.
