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Clinical trials for Globin

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   43881   clinical trials with a EudraCT protocol, of which   7295   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 ).  
     
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    29 result(s) found for: Globin. Displaying page 1 of 2.
    1  2  Next»
    EudraCT Number: 2012-000695-42 Sponsor Protocol Number: HGB-205 Start Date*: 2012-12-31
    Sponsor Name:bluebird bio, Inc.
    Full Title: A Phase I/II Open Label Study Evaluating the Safety and Efficacy of Gene Therapy of the β-Hemoglobinopathies (Sickle Cell Anemia and β-Thalassemia Major) by Transplantation of Autologous CD34+ Stem...
    Medical condition: Severe sickle cell anemia and transfusion-dependent beta-thalassemia major. This study will enroll patients who are eligible for an allogeneic hematopoietic stem cell transplant (HSCT) but do not...
    Disease: Version SOC Term Classification Code Term Level
    14.1 100000004850 10055579 Sickle-cell beta thalassemia LLT
    Population Age: Children, Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: FR (Completed)
    Trial results: View results
    EudraCT Number: 2014-004860-39 Sponsor Protocol Number: TIGET-BTHAL Start Date*: 2015-03-04
    Sponsor Name:OSPEDALE SAN RAFFAELE
    Full Title: A phase I/II study evaluating safety and efficacy of autologous hematopoietic stem cells genetically modified with GLOBE lentiviral vector encoding for the human beta-globin gene for the treatment ...
    Medical condition: Beta talassemia trasfusione dipendente
    Disease: Version SOC Term Classification Code Term Level
    17.1 10010331 - Congenital, familial and genetic disorders 10043391 Thalassaemia beta PT
    Population Age: Children, Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: IT (Completed)
    Trial results: View results
    EudraCT Number: 2021-000212-34 Sponsor Protocol Number: AG348-C-018 Start Date*: 2021-10-11
    Sponsor Name:Agios Pharmaceuticals, Inc.
    Full Title: A Phase 3, Double-blind, Randomized, Placebo-Controlled, Multicenter Study Evaluating the Efficacy and Safety of Mitapivat in Subjects With Transfusion-Dependent Alpha- or Beta-Thalassemia (ENERGIZ...
    Medical condition: Transfusion-Dependent Alpha- or Beta-Thalassemia
    Disease: Version SOC Term Classification Code Term Level
    22.0 100000004850 10081904 Transfusion dependent thalassemia LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: ES (Ongoing) DK (Ongoing) IT (Ongoing) BG (Ongoing) NL (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2020-005736-30 Sponsor Protocol Number: CDAII-LUSPA_FA02-2020 Start Date*: 2023-07-17
    Sponsor Name:FOndazione per la Ricerca sulle ANemie ed EMoglobinopatie in ItaliA - For Anemia
    Full Title: A phase II, multicenter, open label study to evaluate the efficacy and safety of Luspatercept (ACE-536) in adult patients with Congenital Dyserythropoietic Anemia type Il (CDA ll).
    Medical condition: Congenital Dyserythropoietic Anemia type II (CDAII)
    Disease: Version SOC Term Classification Code Term Level
    21.1 10010331 - Congenital, familial and genetic disorders 10081457 Congenital dyserythropoietic anaemia PT
    21.1 10010331 - Congenital, familial and genetic disorders 10081457 Congenital dyserythropoietic anaemia PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: IT (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2021-000211-23 Sponsor Protocol Number: AG348-C-017 Start Date*: 2021-10-15
    Sponsor Name:Agios Pharmaceuticals, Inc.
    Full Title: A Phase 3, Double-blind, Randomized, Placebo-Controlled, Multicenter Study Evaluating the Efficacy and Safety of Mitapivat in Subjects With Non Transfusion-Dependent Alpha- or Beta-Thalassemia (ENE...
    Medical condition: Non–Transfusion-Dependent Alpha- or Beta-Thalassemia
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004850 10074356 Non-transfusion dependent thalassemia LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: ES (Ongoing) DK (Ongoing) IT (Ongoing) NL (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2009-014136-37 Sponsor Protocol Number: Thal-002 Start Date*: 2010-07-13
    Sponsor Name:University of Washington
    Full Title: A pilot study on the safety and efficacy of haemopoietic stem cell mobilization (CD34+ cells) with MOZOBIL ± G-CSF, in adult patients diagnosed with beta-thalassaemia major.
    Medical condition: Beta-thalassaemia major
    Disease: Version SOC Term Classification Code Term Level
    12.0 10004505 Beta thalassaemia LLT
    12.0 10004514 Beta-thalassaemia LLT
    12.0 10043391 Thalassaemia beta LLT
    Population Age: Adults Gender: Male, Female
    Trial protocol: GR (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2017-001366-14 Sponsor Protocol Number: 207757 Start Date*: 2017-09-14
    Sponsor Name:GLAXOSMITHKLINE RESEARCH AND DEVELOPMENT
    Full Title: A long-term safety and efficacy follow-on study in participants with transfusion dependent β-thalassemia who have previously received GSK2696277 (autologous hematopoietic stem cells genetically mod...
    Medical condition: Beta-thalassemia
    Disease: Version SOC Term Classification Code Term Level
    20.1 100000004850 10054660 Thalassemia beta LLT
    Population Age: Children, Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: IT (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2013-001600-11 Sponsor Protocol Number: MP4CO-13-SCD-206 Start Date*: 2013-09-25
    Sponsor Name:Sangart, Inc.
    Full Title: A Phase 2 Multi-center, Randomized, Double-blind, Comparator-Controlled Dose Finding Study to Evaluate MP4CO for the Acute Treatment of Vaso-occlusive Crises in Subjects with Sickle Cell Disease
    Medical condition: Sickle cell disease (SCD) is an autosomal recessive disorder of the β globin gene of the hemoglobin molecule. One single point mutation results in a lifetime of chronic morbidity and mortality. Vas...
    Disease:
    Population Age: Adolescents, Under 18, Adults, Elderly Gender: Male, Female
    Trial protocol: GB (Prematurely Ended) BE (Prematurely Ended)
    Trial results: (No results available)
    EudraCT Number: 2019-000331-63 Sponsor Protocol Number: HGB-210 Start Date*: 2021-02-09
    Sponsor Name: bluebird bio, Inc.
    Full Title: A Phase 3 Study Evaluating Gene Therapy by Transplantation of Autologous CD34+ Stem Cells Transduced Ex Vivo with the LentiGlobin BB305 Lentiviral Vector in Subjects with Sickle Cell Disease.
    Medical condition: Sickle Cell Disease
    Disease: Version SOC Term Classification Code Term Level
    21.0 10010331 - Congenital, familial and genetic disorders 10040644 Sickle cell disease PT
    Population Age: Children, Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: FR (Ongoing) GB (GB - no longer in EU/EEA) NL (Ongoing) IT (Completed)
    Trial results: (No results available)
    EudraCT Number: 2022-002395-36 Sponsor Protocol Number: P-SP420-THAL-01 Start Date*: 2022-12-16
    Sponsor Name:Pharmacosmos A/S
    Full Title: An open-label, dose-escalation, dose-finding, and proof-of-concept trial of SP-420 in subjects with transfusion-dependent β-thalassemia
    Medical condition: Transfusion-dependent β-thalassemia
    Disease: Version SOC Term Classification Code Term Level
    20.1 10010331 - Congenital, familial and genetic disorders 10054660 Thalassemia beta LLT
    Population Age: Adults Gender: Male, Female
    Trial protocol: DK (Ongoing) GR (Ongoing) IT (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2014-003572-23 Sponsor Protocol Number: GCP#01.01.030 Start Date*: 2017-12-27
    Sponsor Name:Gamida Cell Ltd
    Full Title: Allogeneic Stem Cell Transplantation of CordIn™, Umbilical Cord Blood-Derived Ex Vivo Expanded Stem and Progenitor Cells, in Patients with Hemoglobinopathies
    Medical condition: Hemoglobinopathies
    Disease: Version SOC Term Classification Code Term Level
    18.0 100000004850 10054658 Thalassemia LLT
    18.0 100000004850 10040645 Sickle cell disease NOS LLT
    Population Age: Children, Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: FR (Completed)
    Trial results: View results
    EudraCT Number: 2014-005115-16 Sponsor Protocol Number: FORMA-04 Start Date*: 2020-04-22
    Sponsor Name:Octapharma AG
    Full Title: Prospective, open-label, uncontrolled, Phase III study to assess the efficacy, safety, and pharmacokinetics of Octafibrin for on-demand treatment of acute bleeding and to prevent bleeding during an...
    Medical condition: Congenital fibrinogendeficiency
    Disease:
    Population Age: Newborns, Infants and toddlers, Children, Under 18 Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2011-000973-30 Sponsor Protocol Number: AMD-THAL Start Date*: 2011-04-28
    Sponsor Name:FONDAZIONE CENTRO S. RAFFAELE DEL MONTE TABOR
    Full Title: PLERIXAFOR MOBILIZED STEM CELLS AS SOURCE FOR GENE THERAPY OF BETA-THALASSEMIA AMD-THAL .
    Medical condition: transfusion dependent beta thalassemia
    Disease: Version SOC Term Classification Code Term Level
    14.0 10010331 - Congenital, familial and genetic disorders 10043391 Thalassaemia beta PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: IT (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2018-001942-33 Sponsor Protocol Number: CT2-02-17 Start Date*: 2019-01-23
    Sponsor Name:Rare Partners s.r.l. Impresa Sociale
    Full Title: A personalized medicine approach for beta-thalassemia transfusion dependent patients: testing SIROLIMUS in a first pilot clinical trial.
    Medical condition: beta-thalassemic patients
    Disease: Version SOC Term Classification Code Term Level
    20.0 10010331 - Congenital, familial and genetic disorders 10043391 Thalassaemia beta PT
    Population Age: Adults Gender: Male, Female
    Trial protocol: IT (Completed)
    Trial results: (No results available)
    EudraCT Number: 2019-003505-96 Sponsor Protocol Number: ISIS702843-CS2 Start Date*: 2020-01-21
    Sponsor Name:Ionis Pharmaceuticals, Inc.
    Full Title: A Phase 2a, Randomized, Open-Label Study to Evaluate the Efficacy, Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of ISIS 702843 Administered Subcutaneously to Patients with Non-Transf...
    Medical condition: Non-Transfusion Dependent β-Thalassemia Intermedia
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004850 10074356 Non-transfusion dependent thalassemia LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GR (Completed)
    Trial results: View results
    EudraCT Number: 2012-002499-15 Sponsor Protocol Number: A536-04 Start Date*: 2012-12-19
    Sponsor Name:ACCELERON PHARMA INC
    Full Title: A Phase 2, Open-Label, Ascending Dose Study to Evaluate the Effects of ACE-536 in Patients with β-Thalassemia Intermedia
    Medical condition: β-thalassemia intermedia
    Disease: Version SOC Term Classification Code Term Level
    15.1 100000004850 10062923 Thalassemia intermedia LLT
    15.1 100000004850 10054660 Thalassemia beta LLT
    Population Age: Adults Gender: Male, Female
    Trial protocol: IT (Completed) GR (Completed)
    Trial results: View results
    EudraCT Number: 2018-001469-18 Sponsor Protocol Number: CT2-04-17 Start Date*: 2019-04-17
    Sponsor Name:Dipartimento di Scienze della Vita e Biotecnologie dell'Università degli Studi di Ferrara
    Full Title: Treatment of beta-thalassemia patients with rapamycin (sirolimus): from pre-clinical research to a clinical trial
    Medical condition: Beta-thalassemia transfusion dependent patients
    Disease: Version SOC Term Classification Code Term Level
    20.0 10010331 - Congenital, familial and genetic disorders 10043391 Thalassaemia beta PT
    20.0 10010331 - Congenital, familial and genetic disorders 10043391 Thalassaemia beta PT
    Population Age: Adults Gender: Male, Female
    Trial protocol: IT (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2016-003611-35 Sponsor Protocol Number: HGB-212 Start Date*: 2017-07-24
    Sponsor Name:bluebird bio, Inc.
    Full Title: A Phase 3 Single Arm Study Evaluating the Efficacy and Safety of Gene Therapy in Subjects with Transfusion-dependent β-Thalassemia, by Transplantation of Autologous CD34+ Stem Cells Transduced Ex V...
    Medical condition: This study will enroll subjects with transfusion dependent beta-thalassemia, defined by a history of at least 100 mL/kg/year of packed red blood cells (pRBCs) or ≥ 8 transfusions of pRBCs per year...
    Disease: Version SOC Term Classification Code Term Level
    20.1 100000004850 10054660 Thalassemia beta LLT
    Population Age: Children, Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: GB (GB - no longer in EU/EEA) DE (Completed) GR (Completed) FR (Completed) IT (Completed)
    Trial results: View results
    EudraCT Number: 2019-003489-41 Sponsor Protocol Number: CADPT03A12101 Start Date*: 2021-02-24
    Sponsor Name:NOVARTIS PHARMA AG
    Full Title: A first-in-patient Phase I/II clinical study to investigate the safety and efficacy of genome-edited hematopoietic stem and progenitor cells in subjects with severe complications of sickle cell dis...
    Medical condition: Sickle Cell Disease (SCD)
    Disease: Version SOC Term Classification Code Term Level
    21.0 10010331 - Congenital, familial and genetic disorders 10040644 Sickle cell disease PT
    Population Age: Children, Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: IT (Prematurely Ended)
    Trial results: (No results available)
    EudraCT Number: 2011-003121-94 Sponsor Protocol Number: P-Monofer-IBD-02 Start Date*: 2011-12-14
    Sponsor Name:Pharmacosmos A/S
    Full Title: A Prospective, Non-controlled, Safety Study of Intravenous Iron Isomaltoside 1000 (Monofer®) administered by a High Dosing Regimen in Subjects with Inflammatory Bowel Disease (PROMISE)
    Medical condition: Inflammatory Bowel Disease (IBD)
    Disease: Version SOC Term Classification Code Term Level
    16.1 100000004851 10002062 Anaemia iron deficiency LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DK (Completed) SE (Completed) NL (Completed)
    Trial results: View results
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