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

NCT04850105 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 240

Last updated 2025-09-11

No results posted yet for this study

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.

Conditions

  • Hereditary Transthyretin Amyloidosis With Polyneuropthy

Interventions

OTHER

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.

Sponsors & Collaborators

  • United BioSource, LLC

    collaborator INDUSTRY

  • Akcea Therapeutics

    lead INDUSTRY

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-09-21
Primary Completion
2036-03-31
Completion
2036-03-31

Countries

  • Bulgaria
  • Cyprus
  • France
  • Germany
  • Greece
  • Italy
  • Portugal
  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04850105 on ClinicalTrials.gov