Trial Profile

A Phase 3 double-blind placebo-controlled clinical trial of nomacopan in adult hematopoietic stem cell transplant-related thrombotic microangiopathy (HSCT-TMA)

Status: Planning

Phase of Trial: Phase III

Latest Information Update: 16 Oct 2023

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At a glance

29 Sep 2023 According to an Akari Therapeutics media release, company remains on track to start enrollment by the end of 2023 in the registrational Phase 3 study of nomacopan in pediatric HSCT-TMA, which is expected to generate safety and efficacy data that may support U.S. and European regulatory filings for potential marketing authorization in these regions.
29 Sep 2023 According to an Akari Therapeutics media release, a Type C meeting with the U.S. Food and Drug Administration (FDA) is scheduled for 15 November 2023 to discuss adult study design.
14 Jul 2023 New trial record

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