NCT01671111

Study for Transfusionally Iron Overloaded Children, Adolescents and Adults Using FBS0701 (SSP-004184)

A Phase 2, Open-label, Multicentre, Extension Safety and Tolerability Study for Transfusionally Iron Overloaded Children, Adolescents and Adults Using SSP-004184 (SPD602)

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: Shire · Industry
• Sex: All
• Age: 6 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this extension study is to evaluate SSP-004184AQ in patients with transfusional iron overload and to provide data on long term safety and efficacy. SSP-004184AQ is an iron chelator under development for chronic daily oral administration to patients with transfusional iron overload

Conditions

• Iron Overload Due to Repeated Red Blood Cell Transfusions

Interventions

Type	Name	Description
DRUG	SSP-004184AQ	Long term extension study of 8-75 mg/kg/d of SSP-004184AQ (equivalent to 7-68 mg/kg/d free acid or "active" form)

Timeline

• Start date: 2012-08-14
• Primary completion: 2014-04-24
• Completion: 2014-04-24
• First posted: 2012-08-23
• Last updated: 2021-06-29
• Results posted: 2015-08-06

Locations

9 sites across 5 countries: United States, Canada, Italy, Thailand, United Kingdom