NEURO-TTRansform Clinical Trials For AKCEA-TTR-LRx in Participants With Hereditary Transthyretin-Mediated Amyloid Polyneuropathy

NEURO-TTRansform: A Study to Evaluate the Efficacy and Safety of AKCEA-TTR-LRx in Participants With Hereditary Transthyretin-Mediated Amyloid Polyneuropathy

A Phase 3 Global, Open-Label, Randomized Study to Evaluate the Efficacy and Safety of ION-682884 in Patients With Hereditary Transthyretin-Mediated Amyloid Polyneuropathy

Sponsors Lead Sponsor: Ionis Pharmaceuticals, Inc.

Collaborator: Akcea Therapeutics

Source Ionis Pharmaceuticals, Inc.
Brief Summary To evaluate the efficacy and safety of AKCEA-TTR-LRx after administration for 65 weeks to patients with hereditary transthyretin-mediated amyloid polyneuropathy (hATTR-PN), as compared to the NEURO-TTR trial (NCT01737398). For more information, please visit http://www.neuro-ttransform.com/.

Detailed Description This is a multicenter, open-label study in up to 140 participants, who will be randomized to receive subcutaneous (SC) injections of either AKCEA-TTR-LRx once every 4 weeks or inotersen once a week. Participants will also receive daily supplemental doses of the recommended daily allowance of vitamin A. Participants included in the inotersen reference arm will be crossed over to AKCEA-TTR-LRx at Week 37 after completing the Week 35 assessments.
Overall Status Please inquire to assess recruitment status.
Start Date 2020-01-15
Completion Date 2024-01-01
Primary Completion Date 2024-01-01
Phase Phase 3

Please contact Auckland City Hospital,
1-833-445-3230(GILEAD-0) or GileadClinicalTrials@gilead.com

 

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