NCT04850105 A Non-interventional Cohort Safety Study of Patients With hATTR-PN
| NCT ID | NCT04850105 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Akcea Therapeutics |
| Condition | Hereditary Transthyretin Amyloidosis With Polyneuropthy |
| Study Type | OBSERVATIONAL |
| Enrollment | 240 participants |
| Start Date | 2021-09-21 |
| Primary Completion | 2036-03-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 240 participants in total. It began in 2021-09-21 with a primary completion date of 2036-03-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT04850105 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Hereditary Transthyretin Amyloidosis With Polyneuropthy. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04850105 currently recruiting?
Yes, NCT04850105 is actively recruiting participants. Contact the research team at ionisNCT04850105study@clinicaltrialmedia.com for enrollment information.
Where is the NCT04850105 trial being conducted?
This trial is being conducted at Sofia, Bulgaria, Égkomi, Cyprus, Lille, France, Nice, France and 11 additional locations.
Who is sponsoring the NCT04850105 clinical trial?
NCT04850105 is sponsored by Akcea Therapeutics. The trial plans to enroll 240 participants.