NCT01604941

Pharmacokinetics of SSP-004184 in the Treatment of Chronic Iron Overload Requiring Chelation Therapy

A Phase 2, 24 Week, Open Label, Multi-Center Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of SSP-004184 (SPD602) in the Treatment of Chronic Iron Overload Requiring Chelation Therapy

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 32 (actual)
• Sponsor: Shire · Industry
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate SSP-004184AQ in patients with transfusional iron overload whose primary diagnosis is hereditary or congenital anemia. 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	SPD602	50 mg/kg/day orally twice daily for 24 weeks

Timeline

• Start date: 2012-09-14
• Primary completion: 2014-04-18
• Completion: 2014-04-18
• First posted: 2012-05-24
• Last updated: 2021-06-29
• Results posted: 2015-08-17

Locations

12 sites across 5 countries: United States, Canada, Egypt, Italy, Lebanon