Trials / Withdrawn
WithdrawnNCT01927913
Treatment of Iron Overload Requiring Chelation Therapy
A 48-week, Open-label, 2-arm, Parallel-group, Randomized Exploratory Study to Assess Liver Iron Concentration Measured by FerriScan® (R2) Magnetic Resonance Imaging in B-thalassemia Subjects Administered SPD602 (SSP-004184AQ) or Exjade® (Deferasirox) for Treatment of Chronic Transfusional Iron Overload
- Status
- Withdrawn
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 0 (actual)
- Sponsor
- Shire · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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
| Type | Name | Description |
|---|---|---|
| DRUG | SPD602 | 32, 50 or 75 mg/kg/day BID, capsule |
| DRUG | Deferasirox | Per approved country specific label |
Timeline
- Start date
- 2014-11-20
- Primary completion
- 2015-10-30
- Completion
- 2015-10-30
- First posted
- 2013-08-23
- Last updated
- 2021-06-02
Source: ClinicalTrials.gov record NCT01927913. Inclusion in this directory is not an endorsement.