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Clinical Trial Summary

The purpose of this study is to evaluate the safety and efficacy of extended dosing of donidalorsen administered subcutaneously (SC), with alternative dosing and/or dose frequency with donidalorsen in participants with hereditary angioedema (HAE).


Clinical Trial Description

This is an open-label extension study of donidalorsen in up to 24 participants with HAE. The length of participation in the study is approximately 68 weeks, which includes an up to 4-week qualification period, a 52-week treatment period, and a 12-week post-treatment period. Following the Week 53 treatment period visit, participants will receive donidalorsen in an extended treatment period for up to an additional 156 weeks. Participants taking part in the extended treatment period will enter the 12-week post-treatment period after completion of, or early termination from, the extended treatment period. This study was extended to allow participants to receive donidalorsen for an additional 156 weeks following the initial 53-week treatment period. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT04307381
Study type Interventional
Source Ionis Pharmaceuticals, Inc.
Contact
Status Active, not recruiting
Phase Phase 2
Start date April 1, 2020
Completion date April 2025

See also
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