Open label Phase II safety /tolerability dose response with FBS0701
Research type
Research Study
Full title
A Phase 2, 24 week, randomized open label multi-center study to assess the safety and tolerability and pharmacodynamics of FBS0701 in the treatment of chronic iron overload requiring chelation therapy.
IRAS ID
56501
Sponsor organisation
Ferrokin Biosciences Inc
Eudract number
2010-019645-25
ISRCTN Number
ISRCTN17052121
Clinicaltrials.gov Identifier
Research summary
An open label study to investigate the safety and efficacy of two oral daily doses (16 and 32mg/kg) of the iron chelating drug FBS0701, for the treatment of transfusional iron overload in 40 patients between the age of 18 and 60. Patients will be randomised into one of two treatment arms (20 patients per arm) and treated with once daily doses of FBS0701 for 24 weeks. Patients will be washed out from their current chelation therapy for 2-5 days before treatment and 1 week after treatment with FBS0701. Safety will be assessed in the clinic at periodic times during the study, and will include adverse event monitoring, vital signs, blood sampling, urinalyis, physical examinations and ECGs. Patients will also undertake an MRI scan 3 times during the study, once before treatment (baseline) and at weeks 12 and 24
REC name
East of England - Essex Research Ethics Committee
REC reference
10/H0301/37
Date of REC Opinion
19 Jul 2010
REC opinion
Further Information Favourable Opinion