CLINICAL TRIALS PROFILE FOR FERRIPROX
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505(b)(2) Clinical Trials for FERRIPROX
| Trial Type | Trial ID | Title | Status | Sponsor | Phase | Start Date | Summary |
|---|---|---|---|---|---|---|---|
| New Formulation | NCT02442310 ↗ | Comparison of Deferiprone Delayed Release Tablets and Deferiprone Oral Solution in Healthy Volunteers | Completed | Algorithme Pharma Inc | Phase 1 | 2015-05-01 | The purpose of this study is to look at the pharmacokinetics of a new formulation of deferiprone (deferiprone delayed release tablets) under fed and fasting conditions. |
| New Formulation | NCT02442310 ↗ | Comparison of Deferiprone Delayed Release Tablets and Deferiprone Oral Solution in Healthy Volunteers | Completed | ApoPharma | Phase 1 | 2015-05-01 | The purpose of this study is to look at the pharmacokinetics of a new formulation of deferiprone (deferiprone delayed release tablets) under fed and fasting conditions. |
| New Formulation | NCT02465489 ↗ | Comparison of Deferiprone Extended Release Tablets and Ferriprox Immediate Release Tablets in Healthy Volunteers | Completed | ApoPharma | Phase 1 | 2015-06-01 | The purpose of this study is to look at the pharmacokinetics of a new formulation of deferiprone (deferiprone extended release tablets) under fed and fasting conditions. |
| >Trial Type | >Trial ID | >Title | >Status | >Sponsor | >Phase | >Start Date | >Summary |
All Clinical Trials for FERRIPROX
| Trial ID | Title | Status | Sponsor | Phase | Start Date | Summary |
|---|---|---|---|---|---|---|
| NCT00529152 ↗ | Safety and Efficacy of Ferriprox™ (Deferiprone) Oral Solution in Iron Overloaded Pediatric Patients | Completed | ApoPharma | Phase 3 | 2007-08-01 | - The primary objective is to assess the safety of Ferriprox oral solution for the treatment of iron overload in pediatric patients with transfusion-dependent anemia. - The secondary objective is to assess the efficacy of Ferriprox oral solution in reducing iron overload in pediatric patients with transfusion-dependent anemia. |
| NCT00897221 ↗ | A Study Investigating the Long-term Safety and Efficacy of Deferiprone in Patients With Friedreich's Ataxia | Completed | ApoPharma | Phase 2 | 2009-06-01 | The primary objective of this study is to evaluate the long-term safety and tolerability of deferiprone in subjects with Friedreich's ataxia (FRDA). The secondary objective is to evaluate the long-term efficacy of deferiprone for the treatment of FRDA. The tertiary objectives are to evaluate the effect of deferiprone on: 1. cardiac function, 2. quality of life, and 3. functional status. |
| NCT00907283 ↗ | Ferrochelating Treatment in Patients Affected by Neurodegeneration With Brain Iron Accumulation (NBIA) | Active, not recruiting | Ente Ospedaliero Ospedali Galliera | Phase 2 | 2008-11-01 | This trial is a multicenter, unblinded, single-arm pilot study, lasting one year (plus one year extension Amendment n.3 25 August 2009, plus two years follow-up Amendment n.7) , to evaluate the efficacy and safety of the chelator therapy with deferiprone on cerebral iron accumulations. The drug will be administered in the dosage of 15 mg/kg twice daily. The safety and tolerability of the drug will be evaluated by measuring hemochrome every seven days with leukocyte formula count. At 3, 6 and 12 months from the start of treatment, a neurological evaluation will be performed using several specific evaluation scales (International Cooperative Ataxia Rating Scale (ICARS); Unified Parkinson's Disease Rating Scale (UPDRS); Burke-Fahn-Marsden (BFM)). Every 6 months of treatment, a brain magnetic resonance image (MRI) aimed at measuring iron overload quantitatively, if possible. |
| >Trial ID | >Title | >Status | >Sponsor | >Phase | >Start Date | >Summary |
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