Treatment of Iron Overload Requiring Chelation Therapy
NCT01927913 · Status: WITHDRAWN · Phase: PHASE2 · Type: INTERVENTIONAL
Last updated 2021-06-02
Summary
The purpose of this open-label study is to assess liver iron concentration using MRI imaging in subjects with beta-thalassemia when administered with either SPD602 or deferasirox for the treatment of chronic transfusional iron overload.
Conditions
- Transfusional Iron Overload
- Iron Overload
- Iron Chelation
- Beta-thalassemia
- Transfusional Hemosiderosis
- Iron Metabolism Disorders
- Metabolic Diseases
Interventions
- DRUG
-
SPD602
32, 50 or 75 mg/kg/day BID, capsule
- DRUG
-
Deferasirox
Per approved country specific label
Sponsors & Collaborators
-
Shire
lead INDUSTRY
Principal Investigators
-
Study Director · Takeda
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2014-11-20
- Primary Completion
- 2015-10-30
- Completion
- 2015-10-30
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