Iron Overloaded Children, Adolescents and Adults using SSP-004184
Research type
Research Study
Full title
A Phase 2, Open-label, Multicentre, Extension Safety and Tolerability Study for Transfusionally Iron Overloaded Children, Adolescents and Adults Using SSP-004184 (SPD602)
IRAS ID
113984
Contact name
Farrukh Shah
Sponsor organisation
Shire Pharmaceutical Development Ltd
Eudract number
2011-006322-25
Clinicaltrials.gov Identifier
Research summary
This is a follow-on study for patients who participated in a previous study with a study drug called FBS0701. This study is designed to assess the long-term safety and effectiveness of once or twice daily doses of an investigational drug called FBS0701 in transfusionally iron overloaded (i.e. too much iron in the body) patients aged 6 years and older. Approximately 1500 patients will take part from 75 centres worldwide. During their participation in the study patients will be seen in the clinic every 6 weeks during which time the following study procedures will be performed at selected visits: physical examinations, ECGs, vital signs recorded, blood & urine samples collected for laboratory safety tests, MRI scans, glucose intolerance tests, audiometric examinations, visual acuity tests and eye examinations. Participants are expected to be in the study for up to 5 years. It is hoped the information from the study will help in the future treatment of patients with iron overload.
REC name
West Midlands - Coventry & Warwickshire Research Ethics Committee
REC reference
12/WM/0309
Date of REC Opinion
2 Oct 2012
REC opinion
Favourable Opinion