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Last Updated: September 19, 2020

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CLINICAL TRIALS PROFILE FOR FERRIPROX

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505(b)(2) Clinical Trials for FERRIPROX

This table shows clinical trials for potential 505(b)(2) applications. See the next table for all clinical trials
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 >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 >Phase >Start Date >Summary

Clinical Trial Conditions for FERRIPROX

Condition Name

Condition Name for FERRIPROX
Intervention Trials
Iron Overload 7
Sickle Cell Disease 4
Parkinson's Disease 3
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Condition MeSH

Condition MeSH for FERRIPROX
Intervention Trials
Iron Overload 10
Thalassemia 4
beta-Thalassemia 4
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Clinical Trial Locations for FERRIPROX

Trials by Country

Trials by Country for FERRIPROX
Location Trials
United States 19
Canada 8
Egypt 6
France 4
United Kingdom 4
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Trials by US State

Trials by US State for FERRIPROX
Location Trials
California 4
Pennsylvania 4
South Carolina 2
Michigan 2
Louisiana 2
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Clinical Trial Progress for FERRIPROX

Clinical Trial Phase

Clinical Trial Phase for FERRIPROX
Clinical Trial Phase Trials
Phase 4 6
Phase 3 2
Phase 2/Phase 3 4
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Clinical Trial Status

Clinical Trial Status for FERRIPROX
Clinical Trial Phase Trials
Completed 13
Active, not recruiting 5
Not yet recruiting 3
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Clinical Trial Sponsors for FERRIPROX

Sponsor Name

Sponsor Name for FERRIPROX
Sponsor Trials
ApoPharma 17
University Hospital, Lille 3
Ain Shams University 2
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Sponsor Type

Sponsor Type for FERRIPROX
Sponsor Trials
Industry 19
Other 12
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