- Trials with a EudraCT protocol (27)
- Paediatric studies in scope of Art45 of the Paediatric Regulation (2)
27 result(s) found for: Thalassemia major.
Displaying page 1 of 2.
EudraCT Number: 2016-002959-17 | Sponsor Protocol Number: CR-BD-001 | Start Date*: 2016-12-02 | |||||||||||
Sponsor Name:Kiadis Pharma Netherlands B.V. | |||||||||||||
Full Title: An exploratory, open-label study to evaluate the safety and feasibility of ATIR201, a T-lymphocyte enriched leukocyte preparation depleted ex vivo of host alloreactive T-cells (using photodynamic t... | |||||||||||||
Medical condition: Patients with beta-thalassemia major who are eligible for a haploidentical HSCT | |||||||||||||
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Population Age: Children, Adolescents, Under 18, Adults | Gender: Male, Female | ||||||||||||
Trial protocol: GB (Prematurely Ended) | |||||||||||||
Trial results: View results |
EudraCT Number: 2011-005659-15 | Sponsor Protocol Number: ACE-011-B-THAL-001 | Start Date*: 2012-10-04 | |||||||||||||||||||||
Sponsor Name:Celgene Corporation | |||||||||||||||||||||||
Full Title: A Phase 2a, open-label, dose finding study to determine the safety and tolerability of sotatercept (ACE-011) in adults with beta (β)- thalassemia | |||||||||||||||||||||||
Medical condition: Subjects with red blood cell (RBC) transfusion dependent β-thalassemia major and β thalassemia intermedia, as well as non-transfusion dependent β-thalassemia intermedia will take part in this study. | |||||||||||||||||||||||
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Population Age: Adults, Elderly | Gender: Male, Female | ||||||||||||||||||||||
Trial protocol: GB (GB - no longer in EU/EEA) IT (Prematurely Ended) GR (Completed) | |||||||||||||||||||||||
Trial results: View results |
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 | |||||||||||||||||||||||
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Population Age: Adults | Gender: Male, Female | ||||||||||||||||||||||
Trial protocol: GR (Completed) | |||||||||||||||||||||||
Trial results: (No results available) |
EudraCT Number: 2009-014666-25 | Sponsor Protocol Number: 2009-014666-25 | Start Date*: 2010-01-02 | |||||||||||
Sponsor Name:FONDAZIONE FRANCO E PIERA CUTINO | |||||||||||||
Full Title: SEQUENTIAL DEFERASIROX-DEFERIPRONE VERSUS DEFERASIROX OR DEFERIPRONE MULTICENTRE RANDOMIZED TRIAL | |||||||||||||
Medical condition: BETA-THALASSEMIA MAJOR | |||||||||||||
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Population Age: Adolescents, Under 18, Adults | Gender: Male, Female | ||||||||||||
Trial protocol: IT (Prematurely Ended) | |||||||||||||
Trial results: (No results available) |
EudraCT Number: 2014-001281-94 | Sponsor Protocol Number: A536-06 | Start Date*: 2015-03-11 | |||||||||||||||||||||
Sponsor Name:Acceleron Pharma, Inc. | |||||||||||||||||||||||
Full Title: An Open-Label Extension Study to Evaluate the Long-Term Effects of ACE-536 in Patients with β-Thalassemia Previously Enrolled in Study A536-04 | |||||||||||||||||||||||
Medical condition: β-Thalassemia Intermedia and β-Thalassemia major | |||||||||||||||||||||||
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Population Age: Adults | Gender: Male, Female | ||||||||||||||||||||||
Trial protocol: IT (Completed) GR (Completed) | |||||||||||||||||||||||
Trial results: View results |
EudraCT Number: 2015-003535-35 | Sponsor Protocol Number: CICL670A0106E1 | Start Date*: 2016-03-08 | ||||||||||||||||
Sponsor Name:Novartis Pharma AG | ||||||||||||||||||
Full Title: A 4-year Extension to a Phase II a Multicenter Study Evaluating Long-term Safety, Tolerability, Pharmacokinetics and Effects on Liver Iron Concentration of Repeated Doses of 10 mg/kg/Day of Deferas... | ||||||||||||||||||
Medical condition: | ||||||||||||||||||
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Population Age: Children, Adolescents, Under 18 | Gender: Male, Female | |||||||||||||||||
Trial protocol: Outside EU/EEA | ||||||||||||||||||
Trial results: View results |
EudraCT Number: 2014-000931-18 | Sponsor Protocol Number: EL-THOS-001 | Start Date*: 2014-05-27 |
Sponsor Name:Ersi Voskaridou-Dimoula | ||
Full Title: EVALUATION OF EFFICACY OF DENOSUMAB IN PATIENTS WITH THALASSEMIA MAJOR AND OSTEOPOROSIS: A RANDOMIZED, PLACEBO-CONTROLLED, SINGLE-SITE, DOUBLE BLIND PHASE 2B CLINICAL TRIAL | ||
Medical condition: Adult patients with Thalassemia major and osteoporosis | ||
Disease: | ||
Population Age: Adults, Elderly | Gender: Male, Female | |
Trial protocol: GR (Completed) | ||
Trial results: (No results available) |
EudraCT Number: 2012-002920-33 | Sponsor Protocol Number: CLI00076 | Start Date*: 2012-12-10 |
Sponsor Name:CERUS CORPORATION | ||
Full Title: A Randomized Controlled Study to Evaluate Efficacy and Safety of S-303 Treated Red Blood Cells in Subjects with Thalassemia Major Requiring Chronic RBC Transfusion | ||
Medical condition: Subjects with Thalassemia Major Requiring Chronic RBC Transfusion | ||
Disease: | ||
Population Age: Children, Adolescents, Under 18, Adults | Gender: Male, Female | |
Trial protocol: IT (Completed) GB (Completed) | ||
Trial results: View results |
EudraCT Number: 2007-004164-51 | Sponsor Protocol Number: LPI-1/2007 | Start Date*: 2008-03-26 | |||||||||||
Sponsor Name:FONDAZIONE ITALIANA "LEONARDO GIAMBRONE"PER LA GUARIGIONE DALLA TALASSEMIA - ONLUS | |||||||||||||
Full Title: LPI-Labile Plasma Iron in Deferasirox-Treated Thalassemic Patients | |||||||||||||
Medical condition: thalassemic patients diagnosed with chronic iron overload due to regular blood transfusion | |||||||||||||
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Population Age: Children, Adolescents, Under 18, Adults, Elderly | Gender: Male, Female | ||||||||||||
Trial protocol: IT (Completed) | |||||||||||||
Trial results: (No results available) |
EudraCT Number: 2015-004122-33 | Sponsor Protocol Number: HGB-207 | Start Date*: 2016-11-10 | |||||||||||
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, who do not have β0/β0 Genotype, by Transplantation of Autologous ... | |||||||||||||
Medical condition: This study will enroll subjects with transfusion dependent beta-thalassemia, who do not have beta0/beta0 genotype, defined by a history of at least 100 mL/kg/year of packed red blood cells (pRBCs) ... | |||||||||||||
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Population Age: Adolescents, Under 18, Adults | Gender: Male, Female | ||||||||||||
Trial protocol: IT (Completed) DE (Completed) GR (Completed) GB (GB - no longer in EU/EEA) FR (Completed) | |||||||||||||
Trial results: View results |
EudraCT Number: 2005-005913-40 | Sponsor Protocol Number: Treo TM | Start Date*: 2006-01-17 | |||||||||||
Sponsor Name:OSPEDALE POLICLINICO S. MATTEO | |||||||||||||
Full Title: A phase II, multicentre, clinical study evaluating the safety and efficacy of Treosulfan-based conditioning of allogenic transplantation of haemopoietic stem-cells in patients affected by Thalassem... | |||||||||||||
Medical condition: Thalassemia Major | |||||||||||||
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Population Age: Infants and toddlers, Children, Adolescents, Under 18 | Gender: Male, Female | ||||||||||||
Trial protocol: IT (Ongoing) | |||||||||||||
Trial results: (No results available) |
EudraCT Number: 2009-018091-34 | Sponsor Protocol Number: CICL670AGR02 | Start Date*: 2010-07-14 | |||||||||||
Sponsor Name:Novartis (Hellas) S.A.C.I | |||||||||||||
Full Title: A multicenter open label phase II study to evaluate the safety and efficacy of deferasirox in combination with deferioxamine followed by transitioning to deferasirox monotherapy in β-thalassemia pa... | |||||||||||||
Medical condition: Chronic iron overload in patients cardiac iron overload and β thalassemia | |||||||||||||
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Population Age: Adults, Elderly | Gender: Male, Female | ||||||||||||
Trial protocol: GR (Completed) | |||||||||||||
Trial results: View results |
EudraCT Number: 2016-001561-88 | Sponsor Protocol Number: CICL670ATRO4 | Start Date*: 2016-04-14 |
Sponsor Name:Novartis Pharmaceuticals | ||
Full Title: A Phase II, Multi-center, Single-arm, Prospective Study to Evaluate the Safety and Efficacy of Deferasirox in Beta-thalassemia Major Patients After Hematopoietic Stem Cell Transplantation | ||
Medical condition: -Iron overload | ||
Disease: | ||
Population Age: Children, Adolescents, Under 18 | Gender: Male, Female | |
Trial protocol: Outside EU/EEA | ||
Trial results: View results |
EudraCT Number: 2015-002401-10 | Sponsor Protocol Number: TAL2015 | Start Date*: 2015-10-12 | |||||||||||
Sponsor Name:FONDAZIONE CASA SOLLIEVO DELLA SOFFERENZA OPERA DI SAN PIO DA PIETRELCINA OSPEDALE IRCCS | |||||||||||||
Full Title: Pilot multicenter open label study on treatment with Sofosbuvir/Ledipasvir FDC for patients with thalassemia major and HCV infection. | |||||||||||||
Medical condition: Patients with thalassemia major and HCV infection either naïve or on nucleo(s)tide analogs treatment, data on Sofosbuvir-based treatment are currently lacking, while, due to the long infection dura... | |||||||||||||
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Population Age: Adults | Gender: Male, Female | ||||||||||||
Trial protocol: IT (Completed) | |||||||||||||
Trial results: (No results available) |
EudraCT Number: 2010-021062-29 | Sponsor Protocol Number: CICL670A2214 | Start Date*: 2010-12-21 | |||||||||||
Sponsor Name:Novartis Pharma Services AG | |||||||||||||
Full Title: Phase II, open-label, single-arm, multicenter study to evaluate the efficacy and safety of deferasirox in combination with deferoxamine followed by deferasirox monotherapy in patients with severe c... | |||||||||||||
Medical condition: transfusion-dependent patients with TM, DBA or congenital sideroblastic anemia with severe cardiac iron overload | |||||||||||||
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Population Age: Children, Adolescents, Under 18, Adults, Elderly | Gender: Male, Female | ||||||||||||
Trial protocol: GB (Completed) IT (Completed) GR (Completed) | |||||||||||||
Trial results: View results |
EudraCT Number: 2007-000766-20 | Sponsor Protocol Number: CICL670A2206 | Start Date*: 2008-07-17 |
Sponsor Name:Novartis Pharma Services AG | ||
Full Title: A multicenter, randomized, open-label phase II trial evaluating deferasirox compared with deferoxamine in patients with cardiac iron overload due to chronic blood transfusions | ||
Medical condition: Beta-thalassemia major (TM) or Diamond Blackfan anemia (DBA) or myelodysplastic syndromes (MDS) (low and INT-1 risk as per the IPSS for MDS) or sideroblastic anemia and myocardial iron overload as ... | ||
Disease: | ||
Population Age: Children, Adolescents, Under 18, Adults, Elderly | Gender: Male, Female | |
Trial protocol: GB (Completed) IT (Completed) | ||
Trial results: View results |
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 | ||||||||||||||||||
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Population Age: Children, Adolescents, Under 18, Adults | Gender: Male, Female | |||||||||||||||||
Trial protocol: FR (Completed) | ||||||||||||||||||
Trial results: View results |
EudraCT Number: 2009-010088-17 | Sponsor Protocol Number: MID/09 | Start Date*: 2009-02-16 | |||||||||||
Sponsor Name:AZIENDA OSPEDALIERA OSPEDALI GALLIERA | |||||||||||||
Full Title: Whole liver iron overload measured by the biosusceptometer Magnetic Iron Detector (MID) in thalassemia and MDS patients treated with deferasirox | |||||||||||||
Medical condition: Patients with diagnosis of thalassemia major with iron overload or regularly transfused MDS patients (Low/Intermediate-1 IPSS risk and 1 year life expectancy) | |||||||||||||
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Population Age: Adults, Elderly | Gender: Male, Female | ||||||||||||
Trial protocol: IT (Ongoing) | |||||||||||||
Trial results: (No results available) |
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... | |||||||||||||
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Population Age: Children, Adolescents, Under 18, Adults | Gender: Male, Female | ||||||||||||
Trial protocol: FR (Completed) | |||||||||||||
Trial results: View results |
EudraCT Number: 2013-002245-11 | Sponsor Protocol Number: LTF-303 | Start Date*: 2013-11-12 | |||||||||||
Sponsor Name:bluebird bio, Inc. | |||||||||||||
Full Title: Long-term Follow-up of Subjects Treated with Ex Vivo Gene Therapy using Autologous Hematopoietic Stem Cells Transduced with a Lentiviral Vector | |||||||||||||
Medical condition: Subjects treated with gene therapy drug products in a bluebird bio-sponsored or associated clinical study will be invited to participate in this long-term follow-up study to monitor the safety and ... | |||||||||||||
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Population Age: Adults | Gender: Male, Female | ||||||||||||
Trial protocol: FR (Trial now transitioned) DE (Trial now transitioned) GB (GB - no longer in EU/EEA) GR (Trial now transitioned) IT (Trial now transitioned) | |||||||||||||
Trial results: (No results available) |
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