| 1 |
NCT03351829 |
Not yet recruiting |
Gene Therapy of Beta Thalassemia Using a Self-inactivating Lentiviral Vector |
|
- Genetic: Gene-modified autologous stem cells
|
Interventional
|
Not Applicable |
- Shenzhen Geno-Immune Medical Institute
|
Other |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Safety in patients using CTCAE version 4.0 standard to evaluate the level of adverse events
- Treatment responses
- Quality of life
|
20 |
All |
4 Years to 70 Years (Child, Adult, Older Adult) |
NCT03351829 |
GIMI-IRB-17008 |
|
December 1, 2017 |
January 1, 2019 |
December 31, 2020 |
November 24, 2017 |
November 30, 2017 |
|
- Shenzhen Geno-immune Medical Institute
Shenzhen, Guangdong, China
|
|
| 2 |
NCT02453477 |
Active, not recruiting |
Gene Therapy for Transfusion Dependent Beta-thalassemia |
|
- Genetic: Autologous hematopoietic stem cells genetically modified with GLOBE lentiviral vector encoding for the human beta-globin gene
|
Interventional
|
Phase 1
Phase 2 |
- IRCCS San Raffaele
- Fondazione Telethon
- GlaxoSmithKline
|
Other / Industry |
- Allocation: Non-Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Overall survival
- Achievement of hematological engraftment
- Safety of the administration of autologous haematopoietic stem cells transduced with LV-GLOBE
- (and 9 more...)
|
10 |
All |
3 Years to 64 Years (Child, Adult) |
NCT02453477 |
2014-004860-39 (EudraCT) |
TIGET-BTHAL |
May 2015 |
August 2019 |
August 2019 |
May 25, 2015 |
May 4, 2018 |
|
- Ospedale San Raffaele
Milano, Italy
|
|
| 3 |
NCT03275051 |
Recruiting |
Long-term Safety and Efficacy Follow-up of Subjects Treated With GSK2696277 for Transfusion Dependent Beta-thalassemia in San Raffaele Telethon Institute of Gene Therapy-Beta Thalassemia (TIGET-BTHAL) Study |
|
- Other: Safety and Efficacy assessments
|
Interventional
|
Phase 2 |
- GlaxoSmithKline
- San Raffaele Telethon Institute of Gene Therapy (SR-TIGET)
|
Industry / Other |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Number of subjects with absence of abnormal clonal proliferation (ACP)
- Number of subjects with Polyclonal engraftment
- Number of subjects with reduction in red blood cells (RBC) transfusion volume
- (and 19 more...)
|
10 |
All |
3 Years and older (Child, Adult, Older Adult) |
NCT03275051 |
207757 |
|
October 4, 2017 |
May 1, 2026 |
May 1, 2026 |
September 7, 2017 |
October 17, 2017 |
|
- GSK Investigational Site
Milano, Lombardia, Italy
|
|
| 4 |
NCT03276455 |
Not yet recruiting |
Gene Therapy for Beta-Thalassemia Major Using Autologous Hematopoietic Stem Cell Genetically Modified |
|
- Genetic: Autologous CD34+ cells genetically modified
|
Interventional
|
Phase 1
Phase 2 |
- Nanfang Hospital of Southern Medical University
- Guangdong Yike Gene Science and Technology CO.,Ltd
|
Other / Industry |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- incidence of adverse events
- hemoglobin conten
- Hematopoietic stem cell engraftment
- (and 3 more...)
|
10 |
All |
8 Years and older (Child, Adult, Older Adult) |
NCT03276455 |
NanFangHospital |
|
September 15, 2017 |
September 15, 2020 |
September 15, 2021 |
September 8, 2017 |
September 8, 2017 |
|
- Nanfang Hospial
Guangzhou, Guangdong, China
|
|
| 5 |
NCT02626689 |
Completed |
To Document the Burden of Illness on the Quality of Life and the Impact on Healthcare Utilization in (Beta) β-thalassemia Subjects Who Are Transfusion Dependent (TD) and Non-transfusion Dependent (NTD) Receiving Standard of Care |
|
- Other: Quality of Life (QOL) questionnaires
- Other: Healthcare Resource Utilization
|
Observational
|
|
|
Industry |
- Observational Model: Cohort
- Time Perspective: Prospective
|
- Change in the Physical component score (PSC) over the study period versus the country specific population norms using the 36-item Short Form (SF-36) Quality of Life instrument
- Change in the Mental component score (MCS) over the study period versus the country specific population norms using the 36-item Short Form (SF-36) Quality of Life instrument
- Change in the total scores over the study period using the The Functional Assessment of Cancer Therapy-Anemia (FACT-An) questionnaire
- (and 10 more...)
|
100 |
All |
18 Years and older (Adult, Older Adult) |
NCT02626689 |
ACE-536-B-THAL-003 |
|
March 1, 2016 |
January 3, 2017 |
January 3, 2017 |
December 10, 2015 |
April 7, 2017 |
|
- Aghia Sofia Children's Hosptial
Athens, Goudi, Greece - Fondazione IRCCS Ca Granda Ospedale Maggiore
Milano, Italy - American University of Beirut Medical Center
Beirut, Lebanon - (and 2 more...)
|
|
| 6 |
NCT03358498 |
Not yet recruiting |
Quality of Life and Treatment Satisfaction in β-Thalassemia Patients Receiving Deferasirox |
|
- Other: The Medical Outcomes Short-Form 36-Item Health Survey (SF-36v2) It
|
Observational
|
|
|
Other |
- Observational Model: Cohort
- Time Perspective: Cross-Sectional
|
- The Medical Outcomes Short-Form 36-Item Health Survey (SF-36v2)
|
75 |
All |
16 Years to 65 Years (Child, Adult, Older Adult) |
NCT03358498 |
QOLATSIBTPRD |
|
December 1, 2017 |
December 1, 2018 |
March 1, 2020 |
November 30, 2017 |
November 30, 2017 |
|
- Assiut University Hospital
Assiut, Egypt
|
|
| 7 |
NCT02950857 |
Completed |
A Study of EPEG in Beta Thalassemia Patients |
|
|
Interventional
|
Phase 1 |
|
Other |
- Allocation: Non-Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Number of participants in each treatment arm with abnormal laboratory values and/or adverse events that are related to treatment.
- Change in the Hemoglobin from Baseline to the Final Visit
- A mean increase in Hematocrit (Hct) from Baseline to the Final Visit
- (and 2 more...)
|
6 |
All |
18 Years to 65 Years (Adult, Older Adult) |
NCT02950857 |
PETH-001 |
|
June 28, 2017 |
September 27, 2017 |
September 27, 2017 |
November 1, 2016 |
May 25, 2018 |
|
- Faculty of Medicine, Chiang Mai University
Chiang Mai, Thailand
|
|
| 8 |
NCT01206075 |
Completed |
Evaluating the Safety and Effectiveness of Mozobil Mobilization in Adults With Beta-Thalassemia Major |
|
|
Interventional
|
Not Applicable |
- University of Washington
- National Heart, Lung, and Blood Institute (NHLBI)
- George Papanicolaou Hospital
- Genzyme, a Sanofi Company
|
Other / NIH / Industry |
- Allocation: Non-Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Safety and effectiveness of Mozobil for mobilization of patients with beta thalassemia major
- Clonogenic capacity, transducibility, and engraftment potential (in a mouse model) of genetically modified cells
|
20 |
All |
18 Years to 50 Years (Adult) |
NCT01206075 |
36078-B
P01HL053750
2P01HL053750 |
|
October 2010 |
December 2012 |
December 2014 |
September 21, 2010 |
December 30, 2014 |
|
- George Papanicolaou Hospital
Thessaloniki, Greece
|
|
| 9 |
NCT02597595 |
Active, not recruiting |
Effects of Spirulina on Cardiac Functions in Children With Beta Thalassemia Major |
|
|
Interventional
|
Not Applicable |
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Single (Care Provider)
- Primary Purpose: Prevention
|
- cardiac functions measured by echocardiography
- cardiac functions measured by troponin-1 plasma level.
|
60 |
All |
4 Years to 18 Years (Child, Adult) |
NCT02597595 |
2771/09/14 |
|
November 2014 |
October 2017 |
October 2017 |
November 5, 2015 |
April 28, 2017 |
|
- Faculty of Medicine- Tanta University
Tanta, Gharbia, Egypt
|
|
| 10 |
NCT03207009 |
Recruiting |
A Study Evaluating the Efficacy and Safety of the LentiGlobin® BB305 Drug Product in Subjects With Transfusion-Dependent β-Thalassemia, Who Have a β0/β0 Genotype |
|
- Genetic: LentiGlobin BB305 Drug Product
|
Interventional
|
Phase 3 |
|
Industry |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- The proportion of subjects who meet the definition of "transfusion reduction" (TR).
- The proportion of treated subjects who meet the definition of "transfusion independence" (TI). TI is defined as Hb ≥9g/dL without any RBC transfusions for a continuous period of ≥12 months at any time during the study after drug product infusion.
- Percentage of subjects with a reduction in the mL/kg RBC transfused from Month 12 through Month 24 after drug product infusion of at least 50% compared to the average annual RBC transfusion requirement during the 2 years prior to enrollment.
- (and 4 more...)
|
15 |
All |
up to 50 Years (Child, Adult) |
NCT03207009 |
HGB-212 |
|
June 8, 2017 |
April 2021 |
April 2021 |
July 2, 2017 |
February 7, 2018 |
|
- UCSF Benioff Children's Hospital Oakland
Oakland, California, United States - Ann & Robert H. Lurie Children's Hospital of Chicago
Chicago, Illinois, United States - Hopital d'enfants de la Timone
Marseille, France - (and 4 more...)
|
|
| 11 |
NCT02268409 |
Active, not recruiting |
ACE-536 Extension Study - Beta Thalassemia |
|
|
Interventional
|
Phase 2 |
|
Industry |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Long-term safety and tolerability of ACE-536 in patients with β thalassemia who were previously enrolled in study A536-04
- Erythroid response (8-week) in non-transfusion dependent (NTD) patients
- Erythroid response (12-week) in non-transfusion dependent (NTD) patients
- (and 10 more...)
|
64 |
All |
18 Years and older (Adult, Older Adult) |
NCT02268409 |
A536-06 |
|
November 2014 |
February 2021 |
April 2021 |
October 20, 2014 |
January 9, 2018 |
|
- Acceleron Investigative Site
Athens, Greece - Acceleron Investigative Site
Brindisi, Italy - Acceleron Investigative Site
Catania, Italy - (and 4 more...)
|
|
| 12 |
NCT01642758 |
Completed |
Trial of HQK-1001 in Beta Thalassemia Intermedia in Lebanon |
- Beta Thalassemia Intermedia
|
- Drug: Sodium 2,2 dimethylbutyrate
|
Interventional
|
Phase 2 |
- Boston University
- HemaQuest Pharmaceuticals Inc.
|
Other / Industry |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- To measure changes from baseline in total hemoglobin when HQK-1001 is administered orally for 26 weeks in subjects with beta thalassemia intermedia.
- To measure the number of adverse events which occur with HQK-1001 treatment when given over 26 weeks in beta thalassemia intermedia.
- To measure changes from baseline in HbF during treatment with HQK-1001 for 26 weeks in beta thalassemia intermedia.
|
10 |
All |
16 Years to 50 Years (Child, Adult) |
NCT01642758 |
HQK-P2-THAL |
LB-04-THAL |
May 2012 |
November 2012 |
January 2013 |
July 17, 2012 |
March 14, 2013 |
|
- Chronic Care Center
Beirut, Lebanon
|
|
| 13 |
NCT02906202 |
Recruiting |
A Study Evaluating the Efficacy and Safety of the LentiGlobin® BB305 Drug Product in Subjects With Transfusion-Dependent β-Thalassemia, Who do Not Have a β0/β0 Genotype |
|
- Genetic: LentiGlobin BB305 Drug Product
|
Interventional
|
Phase 3 |
|
Industry |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- The proportion of treated subjects who meet the definition of "transfusion independence" (TI).
- Engraftment defined as an absolute neutrophil count ≥500 cells/µL for 3 consecutive days
- Detection of vector-derived replication competent lentivirus (RCL) using a RCL screening assay
- (and 3 more...)
|
23 |
All |
up to 50 Years (Child, Adult) |
NCT02906202 |
HGB-207 |
|
July 2016 |
January 2020 |
January 2020 |
September 20, 2016 |
February 28, 2018 |
|
- Oakland, California, United States
- Chicago, Illinois, United States
- Philadelphia, Pennsylvania, United States
- (and 6 more...)
|
|
| 14 |
NCT03432364 |
Recruiting |
A Study to Assess the Safety, Tolerability, and Efficacy of ST-400 for Treatment of Transfusion-Dependent Beta-thalassemia (TDT) |
- Transfusion Dependent Beta-thalassemia
|
- Genetic: ST-400 Investigational product
|
Interventional
|
Phase 1
Phase 2 |
- Sangamo Therapeutics
- Bioverativ Therapeutics Inc.
|
Industry |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Incidence of Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) in subjects who receive ST-400 as assessed by Common Terminology Criteria for Adverse Events (CTCAE)
- Change from baseline clinical laboratory measurement of Hb fractions (A and F in g/dL)
- Change from baseline percent (%) HbF
- (and 2 more...)
|
6 |
All |
18 Years to 40 Years (Adult) |
NCT03432364 |
ST-400-01 |
|
May 2018 |
May 2020 |
May 2022 |
February 14, 2018 |
May 28, 2018 |
|
- UCSF Benioff Children's Hospital Oakland
Oakland, California, United States - University of Minnesota
Minneapolis, Minnesota, United States
|
|
| 15 |
NCT03101423 |
Recruiting |
Monitoring of Chimerism After Transplantation in Patients With β Thalassemia Major and the Treatment Strategies for the Reduction of Chimerism |
|
- Drug: Interleukin-2
- Drug: Donor Regulatory T-Lymphocytes
|
Interventional
|
Not Applicable |
- First Affiliated Hospital of Guangxi Medical University
|
Other |
- Allocation: Non-Randomized
- Intervention Model: Crossover Assignment
- Masking: Single (Participant)
- Primary Purpose: Treatment
|
- Chimerism after transplantation were monitored using fluorescence labeled multiplex PCR amplification of short tandem repeats (STR-PCR)
|
10 |
All |
Child, Adult, Older Adult |
NCT03101423 |
LBo |
|
August 1, 2016 |
December 31, 2017 |
December 31, 2017 |
April 5, 2017 |
May 9, 2017 |
|
- the First Affiliated Hospital of Guangxi Medical University
Nanning, Guangxi, China
|
|
| 16 |
NCT01745120 |
Completed |
A Study Evaluating the Safety and Efficacy of the LentiGlobin® BB305 Drug Product in Beta-Thalassemia Major Subjects |
|
- Genetic: LentiGlobin® BB305 Drug Product
|
Interventional
|
Phase 1
Phase 2 |
|
Industry |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Evaluate the efficacy of treatment with LentiGlobin® BB305 Drug Product in subjects with β-thalassemia major as measured by the production of hemoglobin containing the therapeutic globin protein [βA-T87Q-globin]
- Evaluate the safety of treatment with LentiGlobin® BB305 Drug Product in subjects with β-thalassemia major as measured by the incidence of adverse events
- Hematopoietic stem cell engraftment
- Assess transgene marking as determined by measurement of the average vector copy number in peripheral blood and bone marrow
|
18 |
All |
12 Years to 35 Years (Child, Adult) |
NCT01745120 |
HGB-204 |
|
August 2013 |
February 8, 2018 |
February 21, 2018 |
December 7, 2012 |
March 30, 2018 |
|
- Oakland, California, United States
- Chicago, Illinois, United States
- Philadelphia, Pennsylvania, United States
- (and 2 more...)
|
|
| 17 |
NCT02173951 |
Unknown † |
An Algorithm to Start Iron Chelation in Minimally Transfused Young Beta-thalassemia Major Patients |
|
|
Interventional
|
Phase 2
Phase 3 |
|
Other |
- Allocation: Randomized
- Intervention Model: Crossover Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- determine the time and number of transfusion units as well as amount of infused iron that will lead to appearance of LPI >0.2 or TSAT>50 % , serum ferritin ≥ 500 ng/ml in the studied thalassemic patients which warrant start of iron chelation
- Evaluation of safety of early use of iron chelation Therapy (ICT) in terms of drug related AEs or SAEs
|
64 |
All |
6 Months to 36 Months (Child) |
NCT02173951 |
start of ICT in young BTM |
|
July 2014 |
July 2015 |
July 2015 |
June 25, 2014 |
January 14, 2015 |
|
- Pediatric Hematology clinic, Ain Shams University
Cairo, Egypt
|
|
| 18 |
NCT00336362 |
Completed |
Evaluating the Safety of G-CSF Mobilization in Individuals With Beta Thalassemia Major |
|
|
Interventional
|
Not Applicable |
- University of Washington
- National Heart, Lung, and Blood Institute (NHLBI)
- George Papanicolaou Hospital
|
Other / NIH |
- Allocation: Non-Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Safety of PBSC mobilization with G-CSF with or without hydroxyurea pretreatment in adults with beta thalassemia major
- Number of CD34+ stem/progenitor cells that are mobilized
- Ability of the obtained stem cells to be transduced with a recombinant lentivirus vector for beta-globin and engraft immunodeficient mice
|
26 |
All |
18 Years to 50 Years (Adult) |
NCT00336362 |
464
2U01HL066947
IRB no. 27527
EudraCT no. 2005-000315-10 |
|
July 2006 |
August 2010 |
August 2010 |
June 13, 2006 |
December 20, 2012 |
|
- George Papanicolaou Hospital
Thessaloniki, Greece
|
|
| 19 |
NCT03381833 |
Recruiting |
A Study With LJPC-401 for the Treatment of Myocardial Iron Overload in Adult Patients With Transfusion-Dependent Beta Thalassemia |
|
|
Interventional
|
Phase 2 |
- La Jolla Pharmaceutical Company
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Effect of LJPC-401 on cardiac iron
- Effect of LJPC-401 on blood iron levels
- Effect of LJPC-401 on clinical chemistry laboratory parameters
- (and 11 more...)
|
100 |
All |
18 Years and older (Adult, Older Adult) |
NCT03381833 |
LJ401-BT01 |
|
November 30, 2017 |
October 2019 |
May 2020 |
December 22, 2017 |
December 26, 2017 |
|
- Investigational Site
San Diego, California, United States
|
|
| 20 |
NCT00069862 |
Completed |
Iron Balance Study of DFO and GT56-252 in Patients With Transfusional Iron Overload Secondary to Beta-Thalassemia |
|
- Drug: Deferitrin (GT56-252)
- Drug: desferoxamine (DFO)
|
Interventional
|
Phase 1
Phase 2 |
- Genzyme, a Sanofi Company
- Sanofi
|
Industry |
- Allocation: Non-Randomized
- Intervention Model: Crossover Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- safety and tolerability
- iron excretion in urine and stool
- pharmacokinetic measurements
|
25 |
All |
18 Years and older (Adult, Older Adult) |
NCT00069862 |
GTC-134-102 |
|
September 2003 |
|
November 2005 |
October 3, 2003 |
March 5, 2015 |
|
- The New York Presbyterian Hospital-Weill Medical College of Cornell University
New York, New York, United States
|
|
| 21 |
NCT01609595 |
Completed |
Study of SDMB (2,2 Dimethylbutyrate, Sodium Salt) in Beta Thalassemia Intermedia in Thailand |
- Beta Thalassemia Intermedia
|
- Drug: sodium 2,2 dimethylbutyrate
|
Interventional
|
Phase 2 |
- Boston University
- Mahidol University
|
Other |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- The number of participants in which an increase in total hemoglobin of at least 1.5 g/dl above average baseline occurs with study drug treatment.
- The proportion of participants in which an increase in fetal hemoglobin occurs above the subjects' averaged baseline levels.
|
10 |
All |
18 Years to 55 Years (Adult) |
NCT01609595 |
ST20-P2T
HQK-1001-Thal P2 |
ST20-P2T |
March 2012 |
November 2012 |
December 2012 |
June 1, 2012 |
March 13, 2013 |
|
- Mahidol University Thalassemia Research Centre
Nakhonpathom, Thailand
|
|
| 22 |
NCT01724138 |
Withdrawn |
An Open Label Study to Evaluate the Pharmacokinetics, Safety, Tolerability and Efficacy of Deferasirox Administered to Chinese Patients With β-thalassemia Major Aged From 2 to Less Than 6 Years Old |
|
|
Interventional
|
Phase 4 |
- Novartis Pharmaceuticals
- Novartis
|
Industry |
- Allocation: Randomized
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- the PK profile of deferasirox in pediatric β-thalassemia major patients aged from 2 to less than 6 years old.
- the PK profile of deferasirox in pediatric β-thalassemia major patients aged from 2 to less than 6 years old: Cmax
- the PK profile of deferasirox in pediatric β-thalassemia major patients aged from 2 to less than 6 years old: Tmax
- (and 2 more...)
|
0 |
All |
2 Years to 71 Years (Child, Adult, Older Adult) |
NCT01724138 |
CICL670ACN02 |
MACS2163 |
June 2013 |
April 2014 |
October 2014 |
November 9, 2012 |
April 20, 2017 |
|
|
|
| 23 |
NCT00790127 |
Completed |
Phase 1/2 Study of HQK-1001 in Patients With Beta Thalassemia |
|
- Drug: HQK-1001
- Drug: Placebo
|
Interventional
|
Phase 1
Phase 2 |
- HemaQuest Pharmaceuticals Inc.
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Primary Purpose: Treatment
|
- Safety as assessed by (1) adverse events, (2) laboratory values (3) vital signs (4) physical exam
- Pharmacokinetics assessed by plasma drug concentration levels
- Pharmacodynamics assessed by red blood cell production and induction of fetal hemoglobin
|
21 |
All |
12 Years to 60 Years (Child, Adult) |
NCT00790127 |
HQP-2008-003b |
|
March 2009 |
May 2010 |
May 2010 |
November 13, 2008 |
May 20, 2011 |
|
- Chronic Care Center
Beirut, Lebanon - Siriraj Hospital
Bangkok, Bangkoknoin District, Thailand
|
|
| 24 |
NCT02671695 |
Active, not recruiting |
Effect of Spirulina Compared to Amlodipine on Cardiac Iron Overload in Children With Beta Thalassemia |
|
- Drug: Spirulina
- Drug: Amlodipine
|
Interventional
|
Not Applicable |
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Double (Care Provider, Outcomes Assessor)
- Primary Purpose: Treatment
|
- cardiac iron concentration by magnetic resonance imaging
- cardiac troponin 1
- N-terminal pro-brain natriuretic peptide
|
40 |
All |
8 Years to 18 Years (Child, Adult) |
NCT02671695 |
22/03/15 |
|
April 2015 |
April 2018 |
April 2018 |
February 2, 2016 |
October 17, 2017 |
|
- Faculty of Medicine- Tanta University
Tanta, Gharbia, Egypt
|
|
| 25 |
NCT00159042 |
Completed |
Genetic Factors Affecting the Severity of Beta Thalassemia |
|
|
Observational
|
|
- Deborah Rund
- Hadassah Medical Organization
|
Other |
- Observational Model: Other
- Time Perspective: Other
|
|
50 |
All |
Child, Adult, Older Adult |
NCT00159042 |
302803-HMO-CTIL |
|
July 2004 |
July 1, 2017 |
July 1, 2017 |
September 12, 2005 |
August 10, 2017 |
|
- Hadassah Medical Organization
Jerusalem, Israel
|
|
| 26 |
NCT02816957 |
Unknown † |
Benefits of Nigella Sativa in Children With Beta Thalassemia Major |
- Nigella Sativa With Beta Thalassemia Major
|
|
Interventional
|
Early Phase 1 |
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Single (Participant)
- Primary Purpose: Treatment
|
- malondialdehyde
- cluster of differentation4 and 8(CD4 and CD8)
- total antioxidant
- (and 4 more...)
|
80 |
All |
3 Years to 18 Years (Child, Adult) |
NCT02816957 |
30794l03l16 |
Nigella |
June 2016 |
June 2017 |
June 2017 |
June 29, 2016 |
April 26, 2017 |
|
- Faculty of Medicine- Tanta University
Tanta, Gharbia, Egypt
|
|
| 27 |
NCT02342145 |
Recruiting |
Efficacy of Basiliximab in the Prevention of Acute Graft-versus-host Disease in Unrelated Allogeneic Hematopoietic Stem Cell Transplantation Therapy for Thalassemia Major |
|
- Drug: Basiliximab,
- Drug: cyclosporine A
- Drug: Methotrexate
- Drug: Mycophenolate mofetil
|
Interventional
|
Phase 4 |
- Affiliated hospital of guangxi medical university,china
- Union hospital of Fujian Medical University
- Zhongshan Hospital Xiamen University
- (and 3 more...)
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Prevention
|
- acute graft-versus-host disease incidence
- Implantation rate
- Transplanted-related mortality
- (and 4 more...)
|
40 |
All |
2 Years to 18 Years (Child, Adult) |
NCT02342145 |
gxmuh-2014-14 |
|
June 2014 |
June 2016 |
December 2018 |
January 19, 2015 |
January 19, 2015 |
|
- Union hospital of fujian medical university
Fuzhou, Fujian, China - the zhongshan hospital of Xiamen University
Xia'men, Fujian, China - The affiliated hospital of guangxi medical university
Nanning, Guangxi, China - (and 2 more...)
|
|
| 28 |
NCT03462784 |
Not yet recruiting |
Complications in Children With B- Thalassemia Major |
|
- Other: Demographic, physical examination, data will becollected .
|
Observational
|
|
|
Other |
- Observational Model: Other
- Time Perspective: Cross-Sectional
|
- Prevelance of Comlications of Beta -Thalassemia major in children
|
201 |
All |
1 Year to 18 Years (Child, Adult) |
NCT03462784 |
Prev TM |
|
May 1, 2018 |
March 1, 2019 |
October 1, 2019 |
March 13, 2018 |
March 13, 2018 |
|
|
|
| 29 |
NCT00809042 |
Completed |
Combination Therapy of Hydroxyurea With L-Carnitine and Magnesium Chloride in Thalassemia Intermedia |
|
- Drug: hydroxyurea
- Drug: L-carnitine and hydroxyurea
- Drug: hydroxyurea and magnesium chloride
- Drug: hydroxyurea,L-carnitine and magnesium chloride
|
Interventional
|
Phase 2 |
- Shiraz University of Medical Sciences
|
Other |
- Allocation: Randomized
- Intervention Model: Factorial Assignment
- Masking: Double (Participant, Care Provider)
- Primary Purpose: Treatment
|
- Hematologic Parameters
- echocardiographic parameters
|
120 |
All |
4 Years to 35 Years (Child, Adult) |
NCT00809042 |
SHaghpanah
3342 |
|
June 2007 |
November 2007 |
December 2007 |
December 16, 2008 |
December 16, 2008 |
|
- Hematology Research Center of Shiraz University of Medical Sciences
Shiraz, Fars, Iran, Islamic Republic of
|
|
| 30 |
NCT00171210 |
Completed
Has Results |
An Extension Study of Iron Chelation Therapy With Deferasirox (ICL670) in β-thalassemia Patients With Transfusional Iron Overload |
- Transfusional Iron Overload in β-thalassemia
|
|
Interventional
|
Phase 3 |
- Novartis Pharmaceuticals
- Novartis
|
Industry |
- Allocation: Non-Randomized
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Long Term Safety and Tolerability Profile of ICL670 Based on the Number of Participants Who Experienced Any Adverse Event
- Long-term Effect of ICL670 on Hepatic Iron Stores Measured by Means of Liver Iron Content (LIC) as Assessed by Liver Biopsy
- Long-term Effect of ICL670 on Hepatic Iron Stores Measured by Means of Liver Iron Content (LIC) as Assessed by SQUID
- (and 9 more...)
|
506 |
All |
2 Years and older (Child, Adult, Older Adult) |
NCT00171210 |
CICL670A0107E1 |
|
October 2004 |
April 2008 |
|
September 15, 2005 |
May 30, 2011 |
May 2, 2011 |
- Children's Hospital Los Angeles
Los Angeles, California, United States - Children's Hospital and Research Center at Oakland
Oakland, California, United States - Stanford Hospital, Division of Oncology
Stanford, California, United States - (and 46 more...)
|
|
| 31 |
NCT00103753 |
Unknown † |
Combined Chelation Treatment With Deferiprone and Deferoxamine in Thalassemia Major |
|
|
Interventional
|
Phase 4 |
- Royal Brompton & Harefield NHS Foundation Trust
- CORDA, The Heart Charity
- The Cooley’s Anemia Foundation,
- (and 2 more...)
|
Other / Industry |
- Allocation: Randomized
- Intervention Model: Single Group Assignment
- Masking: Double
- Primary Purpose: Treatment
|
- Myocardial T2*
- Liver T2*
- LV and RV volumes and function in systole and diastole
- (and 5 more...)
|
65 |
All |
18 Years and older (Adult, Older Adult) |
NCT00103753 |
02 065 |
|
May 2004 |
|
June 2005 |
February 15, 2005 |
June 24, 2005 |
|
- Ospedale Microcitemico, Via Jenner
Cagliari, Sardinia, Italy
|
|
| 32 |
NCT03183375 |
Recruiting |
The Efficacy and Safety of HYDROXYUREA in Management of Beta Thalassemia Patients in Karachi Pakistan |
|
|
Interventional
|
Phase 2 |
- Dr.Saqib Hussain Ansari
- Omair Sana Foundation
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- No. of participants who become responders or partial responders
- The compliance of Hydroxyurea in study participants.
- Number of participants with abnormal/deranged laboratory values
- No. of participants with severe adverse events related to the intervention
|
100 |
All |
6 Months and older (Child, Adult, Older Adult) |
NCT03183375 |
ERB0002 |
|
August 21, 2017 |
April 30, 2018 |
June 30, 2018 |
June 12, 2017 |
September 20, 2017 |
|
- Omair Sana Foundation
Karachi, Sindh, Pakistan
|
|
| 33 |
NCT02307786 |
Unknown † |
Long Term Outcomes in β Thalassemia Major |
|
|
Observational
|
|
- Ann & Robert H Lurie Children's Hospital of Chicago
|
Other |
- Observational Model: Cohort
- Time Perspective: Retrospective
|
- Beta-Thalassemia patients and Quality of Life after HSCT versus supportive care therapy
|
150 |
All |
up to 30 Years (Child, Adult) |
NCT02307786 |
SCT 0414B |
|
June 2014 |
June 2016 |
June 2016 |
December 4, 2014 |
December 4, 2014 |
|
- Ann & Robert H. Lurie Children's Hospital of Chicago
Chicago, Illinois, United States
|
|
| 34 |
NCT00061750 |
Completed |
Safety & Efficacy of ICL670 vs. Deferoxamine in Beta-thalassemia Patients With Iron Overload Due to Blood Transfusions |
|
- Drug: ICL670
- Drug: deferoxamine
|
Interventional
|
Phase 3 |
- Novartis Pharmaceuticals
- Novartis
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Demonstrate non-inferiority to deferoxamine in its effects on liver iron content (LIC)
- Evaluate tolerability profile
- Estimate absolute and relative change of LIC and Total body iron excretion
- (and 2 more...)
|
595 |
All |
2 Years and older (Child, Adult, Older Adult) |
NCT00061750 |
CICL670A0107 |
|
May 2003 |
November 2004 |
|
June 4, 2003 |
April 19, 2012 |
|
- Children's Hospital of Los Angeles
Los Angeles, California, United States - Children's Hospital Oakland
Oakland, California, United States - Stanford Hospital
Stanford, California, United States - (and 4 more...)
|
|
| 35 |
NCT03271541 |
Recruiting |
A Study of Bitopertin (RO4917838) in Adults With Non-Transfusion-Dependent (NTD) Beta-Thalassemia |
|
|
Interventional
|
Phase 2 |
|
Industry |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Safety Outcome: Percentage of Participants with Adverse Events (AEs) - Part 1 only
- Efficacy Outcome: Change in Total Hemoglobin (Hb) Level from Baseline to End of 16-Week Treatment Period in Part 1
- Long-term Safety Outcome : Percentage of Participants with Adverse Events (AEs) - Part 2 only
- (and 12 more...)
|
24 |
All |
18 Years to 55 Years (Adult) |
NCT03271541 |
BP39642
2016-004799-23 |
|
October 26, 2017 |
August 31, 2019 |
October 2, 2019 |
September 5, 2017 |
June 11, 2018 |
|
- Centro della Microcitemia e delle Anemie Congenite - Ospedale Galliera; Oncologia /Cardiologia
Genova, Liguria, Italy - Ospedale Maggiore di Milano; Cardio-Metabolic Diseases
Milano, Lombardia, Italy - Chronic Care Center
Baabda, Lebanon - Siriraj Hospital; Division of Haematology-Oncology
Bangkok Noi, Thailand
|
|
| 36 |
NCT02984475 |
Recruiting |
The Potential Hepatoprotective Effect of Metformin in Patients With Beta Thalassemia Major |
- Beta Thalassemia Major Anemia
|
|
Interventional
|
Phase 4 |
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- liver enzymes tests.
- Metformin Safety - Number of participants with treatment-related adverse events
- liver enzymes and function tests - Alkaline phosphatase (ALP).
- (and 6 more...)
|
60 |
All |
11 Years to 18 Years (Child, Adult) |
NCT02984475 |
CL 1726 |
|
December 2016 |
June 2018 |
December 2018 |
December 7, 2016 |
January 29, 2018 |
|
- Abo El Reesh Hospital
Cairo., Egypt - El Demerdash (Ain Shams Teaching Hospital).
Cairo., Egypt
|
|
| 37 |
NCT01749540 |
Completed |
Study to Evaluate the Effects of ACE-536 in Patients With Beta-thalassemia |
|
|
Interventional
|
Phase 2 |
|
Industry |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Proportion of patients who have an erythroid response.
- Number of patients with adverse events.
- Change in hemoglobin level in non-transfusion dependent patients.
- (and 2 more...)
|
64 |
All |
18 Years and older (Adult, Older Adult) |
NCT01749540 |
A536-04
2012-002499-15 |
|
February 2013 |
November 2015 |
November 2015 |
December 13, 2012 |
December 14, 2016 |
|
- Laiko General Hospital, Ampelokipi
Athens, Greece - Ospedale "A. Perriino" U.O Ematologia
Brindisi, Italy - ARNAS Garibaldi - P.O. Garibaldi Centro
Catania, Italy - (and 5 more...)
|
|
| 38 |
NCT02274233 |
Terminated |
Safety and Pharmacokinetic Study of Escalating Doses of SP-420, an Iron Chelator, in Patients With β-Thalassemia |
- Iron Overload
- Beta-Thalassemia
|
|
Interventional
|
Phase 1 |
|
Industry |
- Allocation: Non-Randomized
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Number of Participants with Adverse Events
- Peak Plasma Concentration (Cmax) of SP-420
- Area under the plasma concentration versus time curve (AUC) of SP-420
|
24 |
All |
18 Years and older (Adult, Older Adult) |
NCT02274233 |
SP-420-702 |
|
October 2014 |
September 2015 |
September 2015 |
October 24, 2014 |
September 29, 2015 |
|
- Sideris Investigative Site
Boston, Massachusetts, United States - Sideris Investigative Site
New York, New York, United States - Sideris Investigative Site
Philadelphia, Pennsylvania, United States - (and 4 more...)
|
|
| 39 |
NCT00560820 |
Completed |
Phase I Study to Examine the Effect of Deferasirox on Renal Hemodynamics in β-thalassemia Patients With Transfusional Iron Overload |
- β-thalassemia
- Transfusional Iron Overload
|
|
Interventional
|
Phase 1 |
- Novartis Pharmaceuticals
- Novartis
|
Industry |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Effect of deferasirox on renal hemodynamics in patients with β-thalassemia and transfusional iron overload.
- Effect of deferasirox on standard markers of renal function
|
11 |
All |
18 Years and older (Adult, Older Adult) |
NCT00560820 |
CICL670A2123
2006-006838-17 |
|
September 2007 |
April 2012 |
April 2012 |
November 20, 2007 |
June 20, 2016 |
|
- Novartis Investigative Site
Cagliari, CA, Italy - Novartis Investigative Site
Genova, GE, Italy - Novartis Investigative Site
Orbassano, Italy
|
|
| 40 |
NCT00658385 |
Completed
Has Results |
Assess the Feasibility and Safety of Granulocyte Colony Stimulating Factor (GCSF) Mobilization of CD34+ Hematopoietic Progenitor Cells in Patients With Betathalassemia Major |
- Beta Thalassemia Major
- Congenital Anemias
|
- Genetic: GCSF, Central venous line placement, Stem cell Collection (leukapheresis)
|
Interventional
|
Not Applicable |
- Memorial Sloan Kettering Cancer Center
|
Other |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Number of Participants With no Serious Adverse Events
|
5 |
All |
18 Years and older (Adult, Older Adult) |
NCT00658385 |
08-030 |
|
April 2008 |
February 2011 |
February 2011 |
April 15, 2008 |
November 25, 2016 |
November 25, 2016 |
- Memorial Sloan Kettering Cancer Center
New York, New York, United States
|
|
| 41 |
NCT00447694 |
Completed |
Cardiac T2* in Beta-thalassemia Patients on Deferasirox Treatment |
- Beta-thalassemia
- Iron Overload
|
|
Interventional
|
Phase 2 |
|
Industry |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Cardiac Iron in B thalassemia patients
- Safety and tolerability of deferasirox
- Changes in liver iron concentration (LIC)
- (and 3 more...)
|
30 |
All |
10 Years and older (Child, Adult, Older Adult) |
NCT00447694 |
CICL670AUS04 |
|
February 2006 |
November 2009 |
November 2009 |
March 15, 2007 |
September 23, 2016 |
|
- Childrens Hospital of Los Angeles
Los Angeles, California, United States - Children's Hospital and Research Center at Oakland
Oakland, California, United States - Children's Memorial Hospital
Chicago, Illinois, United States
|
|
| 42 |
NCT00171171 |
Completed |
A Study of Long-term Treatment With Deferasirox in Patients With Beta-thalassemia and Transfusional Hemosiderosis |
- Beta-Thalassemia
- Hemosiderosis
|
|
Interventional
|
Phase 3 |
|
Industry |
- Allocation: Non-Randomized
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Liver Iron Concentration (as measured by biopsy)
- Iron balance, i.e. Total Body Iron Excretion (based on the iron influx as determined by the amount of red cells transfused and the change in total body iron (TBI) stores)
- Putative surrogate markers such as serum ferritin serum iron, serum transferrin and transferrin saturation
- (and 3 more...)
|
252 |
All |
2 Years and older (Child, Adult, Older Adult) |
NCT00171171 |
CICL670A2402 |
|
May 2004 |
November 2006 |
|
September 15, 2005 |
March 1, 2017 |
|
- Novartis Investigative Site
Cairo, Egypt - Ali Taher
Beirut, Lebanon - Novartis Investigative Site
Muscat, Oman - (and 2 more...)
|
|
| 43 |
NCT02151526 |
Active, not recruiting |
A Study Evaluating the Efficacy and Safety of LentiGlobin BB305 Drug Product in Beta-Thalassemia Major and Sickle Cell Disease |
- Beta-Thalassemia Major
- Sickle Cell Disease
|
- Genetic: LentiGlobin BB305 Drug Product
|
Interventional
|
Phase 1
Phase 2 |
|
Industry |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Success and kinetics of hematopoietic stem cell (HSC) engraftment
- Incidence of transplant related mortality through 100 days post treatment
- Overall survival
- (and 5 more...)
|
7 |
All |
5 Years to 35 Years (Child, Adult) |
NCT02151526 |
HGB-205
2012-000695-42 |
|
July 2013 |
February 2019 |
February 2019 |
May 30, 2014 |
December 18, 2017 |
|
|
|
| 44 |
NCT01459718 |
Completed |
Safety and Efficacy of Deferasirox in Combination With Desferoxamine in β-thalassaemia Patients With Severe Cardiac Iron Overload |
- Transfusion-dependent β-thalassemia Patients
- Cardiac Iron Overload
|
- Drug: Deferasirox
- Drug: Deferasirox + Deferoxamine
|
Interventional
|
Phase 2 |
- Novartis Pharmaceuticals
- Novartis
|
Industry |
- Allocation: Non-Randomized
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Number of patients achieving a complete response (CR)
- Number of patients achieving a partial response (PR)
- Number of patients with stable disease (SD
- (and 6 more...)
|
32 |
All |
18 Years and older (Adult, Older Adult) |
NCT01459718 |
CICL670AGR02
2009-018091-34 |
MACS1097 |
January 2011 |
June 2014 |
June 2014 |
October 26, 2011 |
February 10, 2015 |
|
- Novartis Investigative Site
Athens, GR, Greece - Novartis Investigative Site
Athens, GR, Greece - Novartis Investigative Site
Athens, Greece - Novartis Investigative Site
Patras, Greece
|
|
| 45 |
NCT00001958 |
Completed |
Hydroxyurea to Treat Beta-Thalassemia (Cooley's Anemia) |
- Beta Thalassemia
- Hemoglobinopathy
|
|
Interventional
|
Phase 2 |
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- National Institutes of Health Clinical Center (CC)
|
NIH |
- Primary Purpose: Treatment
|
|
100 |
All |
Child, Adult, Older Adult |
NCT00001958 |
000040
00-DK-0040 |
|
December 1999 |
|
February 2002 |
January 19, 2000 |
March 4, 2008 |
|
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Bethesda, Maryland, United States
|
|
| 46 |
NCT01284738 |
Completed |
Beta-thalassemia and Microparticles |
- Thalassemia Major (TM)
- Thalassemia Intermedia (TI)
- Microparticles (MP)Originating From Platelets, Endothelial Cells and Monocytes
|
|
Interventional
|
Not Applicable |
- Assistance Publique Hopitaux De Marseille
|
Other |
- Allocation: Non-Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
|
- Relationship between TM and TI
- Investigate the mechanisms of the elevated production of MP in thalassemias
|
33 |
All |
15 Years and older (Child, Adult, Older Adult) |
NCT01284738 |
2010-A00198-31
2009-18 |
|
March 2010 |
February 2014 |
|
January 27, 2011 |
August 29, 2014 |
|
|
|
| 47 |
NCT01129076 |
Completed |
Perceptions of Thalassemia Major in Singapore: An Exploratory Study of Stigma |
|
|
Observational
|
|
- National Human Genome Research Institute (NHGRI)
- National Institutes of Health Clinical Center (CC)
|
NIH |
- Time Perspective: Prospective
|
|
30 |
All |
14 Years and older (Child, Adult, Older Adult) |
NCT01129076 |
999910104
10-HG-N104 |
|
April 23, 2010 |
|
January 7, 2016 |
May 24, 2010 |
June 14, 2018 |
|
- Singapore General Hospital Outram Rd.
Singapore, Singapore - KK Women's & Children's Hospital
Singapore, Singapore
|
|
| 48 |
NCT03171831 |
Recruiting |
Haploidentical Hematopoietic Stem Cell Transplantation for Patients With Thalassemia Major |
|
- Drug: Busulfan
- Drug: Cyclophosphamide
- Drug: Fludarabine
- (and 5 more...)
|
Interventional
|
Phase 4 |
- First Affiliated Hospital of Guangxi Medical University
|
Other |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Overall Survival
- Disease Free Survival
- Engraftment
- (and 4 more...)
|
30 |
All |
2 Years to 18 Years (Child, Adult) |
NCT03171831 |
Guangxi-Haplo-HSCT-2016 |
|
April 1, 2017 |
December 31, 2021 |
April 1, 2022 |
May 31, 2017 |
May 31, 2017 |
|
- First Affiliated Hospital of Guangxi Medical University
Nanning, Guangxi, China
|
|
| 49 |
NCT03161899 |
Not yet recruiting |
Evaluation of Nutritional Status in Thalassemia Major Patients in Assiut Children Hospital |
|
|
Observational
|
|
|
Other |
- Observational Model: Case-Only
- Time Perspective: Cross-Sectional
|
- percentage of malnutrition
- aetiology poor growth
- decrease morbidity
|
246 |
All |
6 Years to 14 Years (Child) |
NCT03161899 |
ENST |
|
October 2017 |
May 31, 2018 |
December 1, 2018 |
May 22, 2017 |
July 19, 2017 |
|
|
|
| 50 |
NCT00564941 |
Completed |
Evaluating the Efficacy of Deferasirox in Transfusion Dependent Chronic Anaemias (Myelodysplastic Syndrome, Beta-thalassaemia Patients) With Chronic Iron Overload |
- Myelodysplastic Syndromes
- Beta-Thalassemia
|
|
Interventional
|
Phase 4 |
- Novartis Pharmaceuticals
- Novartis
|
Industry |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- This study will evaluate the safety and efficacy of deferasirox in transfusion dependent Myelodysplastic Syndrome, Beta-thalassaemia major patients with chronic iron overload
- patient's compliance during the study assessed by the number of the unused tablets returned by the patient safety assessed by patient laboratory data, adverse events, serious adverse events
|
309 |
All |
18 Years to 80 Years (Adult, Older Adult) |
NCT00564941 |
CICL670AHU02 |
|
December 2007 |
July 2011 |
July 2011 |
November 29, 2007 |
February 24, 2017 |
|
- Novartis Investigative Site
Budapest, Hungary - Novartis Investigative Site
Debrecen, Hungary - Novartis Investigative Site
Pecs, Hungary - Novartis Investigative Site
Szeged, Hungary
|
|
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