Flag of the European Union EU Clinical Trials Register Help

Clinical trials for Transfusional iron overload

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   44334   clinical trials with a EudraCT protocol, of which   7366   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     
    30 result(s) found for: Transfusional iron overload. Displaying page 1 of 2.
    1  2  Next»
    EudraCT Number: 2011-001077-13 Sponsor Protocol Number: CICL670A2417 Start Date*: 2011-08-11
    Sponsor Name:Novartis Farmacéutica S.A.
    Full Title: Estudio clínico multicéntrico, aleatorizado, comparativo, de distintos regímenes de administración de deferasirox en la tolerabilidad gastrointestinal (GI), en pacientes con síndrome mielodisplásic...
    Medical condition: Sobrecarga de hierro de riesgo bajo o intermedio (int-1) en pacientes con síndrome mielodisplásico (SMD) con ferritina > 1000 mcg/L en la selección o antecedentes de transfusión de por lo menos 20 ...
    Disease: Version SOC Term Classification Code Term Level
    14.0 10027433 - Metabolism and nutrition disorders 10022979 Iron excess HLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: ES (Completed) IT (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2013-000743-33 Sponsor Protocol Number: SPD602-204 Start Date*: 2014-01-16
    Sponsor Name:Shire Development LLC and International Affiliates
    Full Title: 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 β-thalassemia Subjects Admin...
    Medical condition: Patients 18 years of age and older with transfusional iron overload due to β-thalassemia
    Disease: Version SOC Term Classification Code Term Level
    14.1 100000004861 10065974 Chronic iron overload LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: BE (Completed) GB (Prematurely Ended) GR (Prematurely Ended) IT (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2007-004008-10 Sponsor Protocol Number: CICL670AHU02 Start Date*: 2008-01-08
    Sponsor Name:Novartis Hungária Kft.
    Full Title: Evaluating the efficacy of Exjade® (deferasirox) in transfusion dependent chronic anaemias ( Myelodysplasia Syndrome, Beta-thalassaemia major patients) with chronic iron overload
    Medical condition: In- or outpatients with myelodysplasia or beta thalassaemia major, who have chronic iron overload, as a consequence of frequent blood transfusion
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: HU (Completed)
    Trial results: View results
    EudraCT Number: 2011-005675-16 Sponsor Protocol Number: FBS0701-CTP-16 Start Date*: 2012-05-15
    Sponsor Name:FERROKIN BIOSCIENCES INC.
    Full Title: A Phase 2, 24 Week, Randomized, Open Label, Multi-Center Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Two FBS0701 Doses in the Treatment of Chronic Iron Overlo...
    Medical condition: Patients with transfusional iron overload, with the following primary diagnosis:hereditary anemia (such as sickle cell disease),β-thalassemia and Diamond Blackfan anemia
    Disease:
    Population Age: Adults Gender: Male, Female
    Trial protocol: IT (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2011-001718-32 Sponsor Protocol Number: FBS0701CTP-07 Start Date*: 2011-09-07
    Sponsor Name:FERROKIN BIOSCIENCES INC.
    Full Title: A Phase 2, Open Label, Multi-Center, Single-Dose Pharmacokinetics, and Multiple Dose Study of the Safety, Efficacy and Tolerability of FBS0701 in a Pediatric Population with Transfusional Iron Over...
    Medical condition: Patients with documented transfusional iron overload ages 6 to less than 18 years old will be studied. Patients with transfusion-dependent anemias will be eligible regardless of the cause of thei...
    Disease: Version SOC Term Classification Code Term Level
    14.1 10027433 - Metabolism and nutrition disorders 10065974 Chronic iron overload LLT
    Population Age: Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: IT (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2018-003542-17 Sponsor Protocol Number: FISM_IRON-MDS Start Date*: 2019-05-06
    Sponsor Name:FONDAZIONE ITALIANA SINDROMI MIELODISPLASTICHE ETS
    Full Title: Early and low dose Deferasirox (3.5 mg/kg FCT) to suppress NTBI and LPI as early intervention to prevent tissue iron overload in lower risk MDS
    Medical condition: Adult patients with low risk MDS
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004864 10028532 Myelodysplasia LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: IT (Prematurely Ended)
    Trial results: (No results available)
    EudraCT Number: 2004-003953-16 Sponsor Protocol Number: CICL670A2409 Start Date*: 2007-05-20
    Sponsor Name:Novartis Pharma Services AG
    Full Title: A one-year, open-label, single arm, multi-centre trial evaluating the efficacy and safety of oral ICL670 (20 mg/kg/day) in patients diagnosed with transfusion-dependent iron overload
    Medical condition: Transfusional iron overload
    Disease:
    Population Age: Children, Adolescents, Under 18, Adults, Elderly Gender: Male, Female
    Trial protocol: GB (Completed) ES (Completed) IT (Completed) DK (Completed) BE (Completed) DE (Completed) NO (Completed) AT (Completed)
    Trial results: View results
    EudraCT Number: 2010-023217-61 Sponsor Protocol Number: 10/0174 Start Date*: 2012-01-27
    Sponsor Name:University College London
    Full Title: A phase IV, open-label, partial cross-over partial parallel, randomized, multi-centre study to compare the gastrointestinal tolerability of once daily oral deferasirox, when administered before or ...
    Medical condition: transfusional haemosiderosis
    Disease: Version SOC Term Classification Code Term Level
    14.1 10027433 - Metabolism and nutrition disorders 10019024 Haemosiderosis PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2006-006838-17 Sponsor Protocol Number: CICL670A2123 Start Date*: 2007-09-13
    Sponsor Name:NOVARTIS FARMA
    Full Title: Phase I study to examine the effect of deferasirox on renal hemodynamics in β-thalassemia patients with transfusional iron overload
    Medical condition: thalassemia
    Disease: Version SOC Term Classification Code Term Level
    6.1 10022958 HLGT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: IT (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2006-003970-89 Sponsor Protocol Number: CICL670ADE02 Start Date*: 2007-12-21
    Sponsor Name:Novartis Pharma GmbH
    Full Title: A one-year, open-label, single arm, multi-center trial evaluating the efficacy and safety of oral ICL670 (20 mg/kg/day) in patients three to six months after allogeneic hematopoietic cell transplan...
    Medical condition: allogeneic hematopoietic cell transplantation with iron overload
    Disease: Version SOC Term Classification Code Term Level
    9.1 10001756 Allogenic bone marrow transplantation therapy LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed)
    Trial results: View results
    EudraCT Number: 2009-012418-38 Sponsor Protocol Number: CICL670A2302 Start Date*: 2009-12-18
    Sponsor Name:NOVARTIS FARMA
    Full Title: A multi-center, randomized, double-blind, placebocontrolled clinical trial of deferasirox in patients with myelodysplastic syndromes (low/int-1 risk) and transfusional iron overload
    Medical condition: myelodysplastic syndromes(low/int-1 risk)
    Disease: Version SOC Term Classification Code Term Level
    12.1 10019613 Hemosiderosis LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: IT (Completed) FI (Prematurely Ended) DK (Completed) GB (Completed) BE (Completed) GR (Completed) NL (Prematurely Ended) BG (Completed)
    Trial results: View results
    EudraCT Number: 2010-019645-25 Sponsor Protocol Number: SPD602-201 Start Date*: 2010-07-19
    Sponsor Name:Shire Development LLC
    Full Title: A Phase 2, 24 Week, Randomized, Open Label, Multi-Center Study to Assess the Safety, Tolerability, and Pharmacodynamics of SSP-004184 in the Treatment of Chronic Iron Overload Requiring Chelation T...
    Medical condition: Patients with transfusional iron overload due to hereditary anemias such as sickle cell disease, β-thalassemia and Diamond-Blackfan anemia; acquired anemias such as Myelodysplastic Syndrome and oth...
    Disease: Version SOC Term Classification Code Term Level
    14.1 100000004861 10065974 Chronic iron overload LLT
    Population Age: Adults Gender: Male, Female
    Trial protocol: GB (Completed) IT (Completed)
    Trial results: View results
    EudraCT Number: 2016-003482-25 Sponsor Protocol Number: CICL670F2429 Start Date*: 2018-04-19
    Sponsor Name:Novartis Pharma AG
    Full Title: A single-arm interventional Phase IV, post-authorisation study evaluating the safety of pediatric patients with transfusional hemosiderosis treated with deferasirox crushed film coated tablets
    Medical condition: Transfusional Hemosiderosis
    Disease: Version SOC Term Classification Code Term Level
    20.1 100000004861 10019613 Hemosiderosis LLT
    Population Age: Children, Under 18 Gender: Male, Female
    Trial protocol: GB (Completed) IT (Completed)
    Trial results: View results
    EudraCT Number: 2011-004217-17 Sponsor Protocol Number: CICL670AUS32 Start Date*: 2011-12-09
    Sponsor Name:Novartis Pharmaceuticals Corporation
    Full Title: A single-arm, open-label study of the Palatability and Tolerability of Exjade Taken with Meals, with Different Liquids or Crushed and Added to Food
    Medical condition: transfusional hemosiderosis
    Disease: Version SOC Term Classification Code Term Level
    14.0 10027433 - Metabolism and nutrition disorders 10065974 Chronic iron overload LLT
    Population Age: Children, Adolescents, Under 18, Adults, Elderly Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2011-006322-25 Sponsor Protocol Number: SPD602-301 Start Date*: 2012-10-08
    Sponsor Name:Shire Development LLC
    Full Title: A Phase 2, Open-label, Multicentre, Extension Safety and Tolerability Study for Transfusionally Iron Overloaded Children, Adolescents and Adults Using SSP-004184 (SPD602).
    Medical condition: Patients with transfusional iron overload due to hereditary anemias such as sickle cell disease, beta-thalassemia and Diamond-Blackfan anemia; aquired anemias such as Myelodysplastic Syndrome and o...
    Disease: Version SOC Term Classification Code Term Level
    16.1 100000004861 10065974 Chronic iron overload LLT
    Population Age: Children, Adolescents, Under 18, Adults, Elderly Gender: Male, Female
    Trial protocol: GB (Prematurely Ended) IT (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2012-000658-67 Sponsor Protocol Number: DEEP-1 Start Date*: 2012-07-31
    Sponsor Name:Consorzio per Valutazioni Biologiche e Farmacologiche
    Full Title: Multi-centre, oral single dose experimental and modelling study to evaluate the pharmacokinetics of deferiprone in patients aged from 1 month to less than 6 years of age affected by transfusion-dep...
    Medical condition: chronic iron overload
    Disease: Version SOC Term Classification Code Term Level
    17.1 100000004861 10065974 Chronic iron overload LLT
    Population Age: Infants and toddlers, Children, Under 18 Gender: Male, Female
    Trial protocol: IT (Completed) Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2008-003230-22 Sponsor Protocol Number: CICL670AIT07 Start Date*: 2008-11-04
    Sponsor Name:NOVARTIS FARMA
    Full Title: Multicenter, open label, prospective study to evaluate the efficacy and safety of deferasirox 30 mg/kg/day for 52 weeks, in transfusion-dependent β-thalassemic patients with cardiac MRI ...
    Medical condition: cardiac iron overload
    Disease: Version SOC Term Classification Code Term Level
    9.1 10019024 Haemosiderosis LLT
    Population Age: Children, Adolescents, Under 18, Adults, Elderly Gender: Male, Female
    Trial protocol: IT (Completed)
    Trial results: View results
    EudraCT Number: 2014-005086-70 Sponsor Protocol Number: SHP602-206 Start Date*: 2015-09-11
    Sponsor Name:SHIRE DEVELOPMENT LLC AND INTERNATIONAL AFFILIATES
    Full Title: A Multicenter Study to Monitor for the Potential Development of Renal Tumors in Subjects With Transfusional Iron Overload Who Were Previously Exposed to Deferitazole
    Medical condition: n patients with B-thalassemia, regular transfusions are not only essential to maintain acceptable hemoglobin levels for treatment of the underlying anemia but also to suppress endogenous erythropoi...
    Disease: Version SOC Term Classification Code Term Level
    21.0 100000004861 10065974 Chronic iron overload LLT
    Population Age: Children, Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: IT (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2013-002181-39 Sponsor Protocol Number: LA38-0411 Start Date*: 2013-10-28
    Sponsor Name:ApoPharma Inc.
    Full Title: The efficacy and safety of Ferriprox® for the treatment of transfusional iron overload in patients with sickle cell disease or other anemias
    Medical condition: iron overload in sickle cell disease or other anemias
    Disease: Version SOC Term Classification Code Term Level
    20.0 10005329 - Blood and lymphatic system disorders 10005329 Blood and lymphatic system disorders SOC
    Population Age: Children, Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: GB (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2004-000597-31 Sponsor Protocol Number: CICL670A 0109E1 Start Date*: 2008-06-02
    Sponsor Name:Novartis Pharmaceuticals UK Ltd
    Full Title: A one year open label, non comparative extension to a randomised, multicentre, phase II study to evaluate the asfety, tolerability, pharmacokinetics and effects on iron concentration of repeated do...
    Medical condition: Sickle cell disease patients with transfusional hemosiderosis
    Disease:
    Population Age: Children, Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: GB (Completed) IT (Completed)
    Trial results: View results
    Download Options:
    Number of Trials to download:
    Download Content:
    Download Format:
    Note, where multi-state trials are shown in search results, selecting "Full Trial details" will download full information for each of the member states/countries involved in the trial.
    1  2  Next»
    Query did not match any studies.
    For support, Contact us.
    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

    European Medicines Agency © 1995-Sun May 04 20:56:58 CEST 2025 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA