Safety, Efficacy and Pharmacokinetics of an Oral Iron Chelator Given for a Year to Pediatric Patients With Iron Overload
Status:
Terminated
Trial end date:
2014-05-13
Target enrollment:
Participant gender:
Summary
This is an open-label study to assess the pharmacokinetics, safety, efficacy and tolerability
of SSP-004184AQ. The study consists of two phases: the pharmacokinetic phase, using a single
16 mg/kg dose of SSP-004184AQ; and the chronic dosing phase, during which patients will
receive an additional 48 weeks of SSP-004184AQ dosing. Two age groups will be studied: 6-<12,
and 12-<18 years old. The study is designed to initially assess the pharmacokinetics and
safety of SSP-004184AQ in older children (adolescents, 12-<18 years old) and then if deemed
safe, in younger children (6-<12 years old).