Safety and Pharmacodynamic Study of an Oral Iron Chelator Given for 6 Months to Patients With Iron Overload

PHASE2CompletedINTERVENTIONAL
Enrollment

51

Participants

Timeline

Start Date

August 13, 2010

Primary Completion Date

January 8, 2013

Study Completion Date

January 8, 2013

Conditions
Transfusional Iron OverloadBeta-thalassemia
Interventions
DRUG

SPD602 (FBS0701, SSP-004184)

Oral FBS0701 taken one time daily for up to 96 weeks.

Trial Locations (9)

94609

Children's Hospital and Research Center of Oakland, Oakland

02115

Children's Hospital of Boston, Boston

Unknown

Ospedale Regionale Microcitemie, Cagliari

Centro della Microcitemia e delle Anemie Congenite, Genoa

Thalassemia Center San Luigi Hospital, Orbassano

Siriraj Hospital, Mahidol University, Bangkok

Pediatric Hematology, Ege University Hospital, Izmir

University College London Hospital, London

Whittington Hospital, London

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Shire

INDUSTRY