RecruitingNot Applicable

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

Bulgaria, Cyprus, France240 participantsStarted 2021-09-21

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

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

What they're measuring

Further characterization of the long-term safety of TEGSEDI in patients with hATTR-PN under real-world conditions.

Timeframe: 10 years

Trial details

NCT IDNCT04850105

SponsorAkcea Therapeutics

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2036-03-31

Contact for this trial

Ionis Pharmaceuticals

(844) 915-5145 ionisNCT04850105study@clinicaltrialmedia.com

View on ClinicalTrials.gov More Hereditary Transthyretin Amyloidosis With Polyneuropthy trials