Efficacy and Safety of Deferasirox in Patients With Myelodysplastic Syndrome and Transfusion-dependent Iron Overload
NCT ID: NCT00481143
Last Updated: 2017-05-31
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
63 participants
INTERVENTIONAL
2007-05-31
Brief Summary
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This trial is not recruiting patients in the United States.
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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deferasirox
ICL670/Deferasirox
Interventions
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ICL670/Deferasirox
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Patients of either gender and age ≥ 18 years
* History of at least 20 units of red blood cell transfusions or 100mL/kg of prepacked red blood cells (PRBCs)
* Patients can be either naïve to iron chelation or have had prior treatment with deferoxamine (DFO) or deferiprone (L1)
* Females of childbearing potential must use double-barrier contraception, oral contraceptive plus barrier contraceptive, or must have undergone clinically documented total hysterectomy and/or oophorectomy, tubal ligation or be postmenopausal defined by amenorrhea for at least 12 months.
Exclusion Criteria
* Treatment with deferasirox (ICL670) before study start
* Patients with a concomitant malignant disease
* Patients with out of range lab values
* History of nephrotic syndrome
* Patients with a previous history of clinically relevant ocular toxicity related to iron chelation
* Systemic diseases (cardiovascular, renal, hepatic, etc.) which would prevent the patient from undergoing study treatment
* Patients treated with systemic investigational drugs within the past 4 weeks or topical investigational drug within the past 7 days
* Any other surgical or medical condition which might significantly alter the absorption, distribution, metabolism or excretion of any drug.
* Patients with active uncontrolled infectious disease
* Pregnancy or breast feeding
18 Years
ALL
No
Sponsors
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Novartis Pharmaceuticals
INDUSTRY
Responsible Party
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Principal Investigators
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Novartis Pharmaceuticals
Role: STUDY_DIRECTOR
Novartis Pharmeceuticals
Locations
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Novartis Investigative Site
Berlin, , Germany
Countries
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References
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Nolte F, Hochsmann B, Giagounidis A, Lubbert M, Platzbecker U, Haase D, Luck A, Gattermann N, Taupitz M, Baier M, Leismann O, Junkes A, Schumann C, Hofmann WK, Schrezenmeier H. Results from a 1-year, open-label, single arm, multi-center trial evaluating the efficacy and safety of oral Deferasirox in patients diagnosed with low and int-1 risk myelodysplastic syndrome (MDS) and transfusion-dependent iron overload. Ann Hematol. 2013 Jan;92(2):191-8. doi: 10.1007/s00277-012-1594-z. Epub 2012 Oct 17.
Other Identifiers
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CICL670ADE03
Identifier Type: -
Identifier Source: org_study_id
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