NCT04092205

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

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 13 (actual)
• Sponsor: EmeraMed · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Detailed 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.

Conditions

• Beta Thalassemia Major

Interventions

Type	Name	Description
DRUG	Emeramide	Lipophilic, membrane passing Metal chelator and anti oxidant

Timeline

• Start date: 2019-11-21
• Primary completion: 2020-07-30
• Completion: 2020-08-30
• First posted: 2019-09-17
• Last updated: 2021-08-26

Locations

1 site across 1 country: Albania