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Last Updated: November 25, 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.
NCT00943748 Efficacy and Safety of the Iron Chelator Deferiprone in Parkinson's Disease Completed University Hospital, Lille Phase 2/Phase 3 2009-10-01 Few available drugs can slow the progression of neurodegenerative pathologies such as Parkinson's disease (PD). One of the recent hypotheses concerning the reduction of oxidative stress and neuron death features a harmful effect of iron, which may reach abnormally high levels in the substantia nigra (SN) pars compacta (iron overload has been seen in the substantia nigra in parkinsonian patients and in the 1-methyl-4-phenyl-1,2,3,6-tetrahydropyridine (MPTP) mouse model of PD). Iron overload is harmful because it reacts with hydrogen peroxide (H2O2) produced during the oxidative deamination of dopamine, generating hydroxyl radicals which then damage proteins, DNA and phospholipid membranes and may be responsible for neuron death. The use of an iron chelator (clioquinol) produces a reduction in neuron death in the MPTP mouse model. In humans, a special, partially refocused interleaved multiple echo (PRIME) MR sequence has been used to study the relaxation time (T2*) and quantify iron overload in the SN of PD patients and the nucleus dentatus of patients with Friedreich's ataxia. T2* sequences have revealed a decrease in iron overload following treatment with the chelator deferiprone, in parallel with a clinical improvement in these patients. Furthermore, the very recent open label use of deferiprone in rare serious, systemic, neurological iron overload diseases (Neurodegeneration with Brain Iron Accumulation (NBIA)) has revealed a clinical improvement after 6 months, with 2 case reports from our group and another from an Italian group (Forni et al., 2008). The safety of the low dosages of deferiprone (20 to 30 mg/kg/day) used in neurology appears to be much greater than for the high dosages (75 to 100 mg/kg/day in 3 doses) used in hematology to decrease post-transfusion iron overloads in thalassemia major. Hence, the investigators wish to evaluate the effect of treatment with an oral iron chelator which is capable of crossing the blood-brain barrier (deferiprone) on iron overload in the SN(as assessed by the T2* sequence) with respect to the progression of clinical sign in PD. It is expected a 6-month course of deferiprone able to produce a moderate reduction in iron overload of the SN, associated with a drop in the motor handicap score. Depending on the risk/benefit balance determined in this initial pilot study, a larger, multicenter neuroprotection study could be envisaged.
NCT01511848 Study Of Efficacy,Safety of Combined Deferasirox and Deferiprone Versus Combined Deferiprone and Desferal In Conditions of Iron Overload Unknown status Ain Shams University Phase 2/Phase 3 2012-02-01 Interventional Allocation: Randomized Endpoint Classification: Safety/Efficacy Study of combined chelation therapy Masking: Open Label Primary Purpose: Treatment of transfusional iron overload Primary Outcome Measures: • The primary outcome measure is to assess efficacy in lowering serum ferritin level(the change in serum ferritin compared to baseline) with combining DFP and deferasirox compared to combined DFP and DFO in conditions with severe chronic iron overload; showing an up-trend of SF over previous 12 months on single chelator. Secondary Outcome Measures: • The secondary outcome measure is to determine the number of patients who will develop adverse events in order to assess safety upon administering the drugs in combination (DFP and DFX) compared to the combination of DFO and DFP.
>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
Healthy 3
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Condition MeSH

Condition MeSH for Ferriprox
Intervention Trials
Iron Overload 10
Thalassemia 4
beta-Thalassemia 4
Anemia, Sickle Cell 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
Pennsylvania 4
California 4
Illinois 2
South Carolina 2
Michigan 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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