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Phase 2a Pilot Study of NBMI Treatment in Patients With Beta Thalassemia Major, Requiring Iron Chelation — EMERA007  

Beta Thalassemia Major Clinical Trial

Official title:
EMERA007 - An Open Label, Active-treatment Controlled, Phase 2a Pilot Study to Explore Safety and Efficacy of NBMI Treatment in Patients With Beta Thalassemia Major, Requiring Iron Chelation

Clinical Trial Summary

A pilot study to explore safety and efficacy of NBMI treatment in patients with Beta Thalassemia Major requiring iron chelation Investigational product: NBMI (N1,N3-bis(2-mercaptoethyl) isophthalamide), INN: Emeramide Indication: Beta Thalassemia Major

Clinical Trial Description

Patients with iron overload, not controlled with current therapy will be enrolled to the study. After initial treatment with standard chelation therapy (deferasirox), patients will receive 600 mg daily dose of emeramide (NBMI) for 28 days. After that follow up period on standard treatment with deferasirox shall follow. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04092205
Study type Interventional
Source EmeraMed
Contact
Status Completed
Phase Phase 2
Start date November 21, 2019
Completion date August 30, 2020
View Details
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