- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00564941
Evaluating the Efficacy of Deferasirox in Transfusion Dependent Chronic Anaemias (Myelodysplastic Syndrome, Beta-thalassaemia Patients) With Chronic Iron Overload
February 22, 2017 updated by: Novartis Pharmaceuticals
This study will evaluate the safety and efficacy of deferasirox in transfusion dependent Myelodysplastic Syndrome, Beta-thalassaemia major patients with chronic iron overload
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
309
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Budapest, Hungary
- Novartis Investigative Site
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Debrecen, Hungary
- Novartis Investigative Site
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Pecs, Hungary
- Novartis Investigative Site
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Szeged, Hungary
- Novartis Investigative Site
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 80 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion criteria:
- In- or outpatients with myelodysplasia / with risk of low or intermedier-1 according to the International Prognostic Scoring System (IPSS) confirmed by bone marrow evaluation within 3 month/ or beta thalassaemia major patients, who have chronic iron overload, as a consequence of frequent blood transfusion
- Serum ferritin> 1800 µg/L
- Age: 18-80 years
- men and women
- Chronic iron overload caused by at least 30 units and maximum 100 units of blood of packed red blood cells
- Deferoxamin therapy is contraindicated or inadequate or unable to use in the recommended dose due to intolerability or other reason
- Eastern Cooperative Oncology Group (ECOG) performance status score between 0-2
- written informed consent
Exclusion criteria:
- beta thalassaemia minor,
- haemosiderosis caused by other than chronic transfusional iron overload,
- patients with impaired renal function (Creatinin clearance< 60 ml/ min),
- pregnancy,
- lactation,
- patient of childbearing potential unwilling to use contraceptive precautions
- known hypersensitivity to deferasirox or any ingredients,
- impaired hepatic function (SGOT,SGPT 5x above UNL).
- Patients severely ill due to underlying disease progression or other severe concomitant disease.
- Patients with poor prognosis of karyotype
- patients with malabsorption caused by inflammatory bowel disease, gastrectomy, pancreatitis or other medical condition
- History of nephrotic syndrome
- Significant proteinuria
- Patients with a previous history of clinically relevant ocular toxicity related to iron chelation
- Patients with positive test to HIV
Other protocol-defined inclusion/exclusion criteria may apply
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: Deferasirox
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Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
This study will evaluate the safety and efficacy of deferasirox in transfusion dependent Myelodysplastic Syndrome, Beta-thalassaemia major patients with chronic iron overload
Time Frame: monthly during the therapy and at the end of the treatment (aftr 9 months therapy)
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monthly during the therapy and at the end of the treatment (aftr 9 months therapy)
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
Time Frame: during the treatment (9 months)
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during the treatment (9 months)
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
December 1, 2007
Primary Completion (Actual)
July 1, 2011
Study Completion (Actual)
July 1, 2011
Study Registration Dates
First Submitted
November 28, 2007
First Submitted That Met QC Criteria
November 28, 2007
First Posted (Estimate)
November 29, 2007
Study Record Updates
Last Update Posted (Actual)
February 24, 2017
Last Update Submitted That Met QC Criteria
February 22, 2017
Last Verified
February 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pathologic Processes
- Metabolic Diseases
- Neoplasms
- Disease
- Bone Marrow Diseases
- Hematologic Diseases
- Genetic Diseases, Inborn
- Anemia
- Iron Metabolism Disorders
- Precancerous Conditions
- Anemia, Hemolytic, Congenital
- Anemia, Hemolytic
- Hemoglobinopathies
- Syndrome
- Myelodysplastic Syndromes
- Iron Overload
- Preleukemia
- Thalassemia
- beta-Thalassemia
- Molecular Mechanisms of Pharmacological Action
- Chelating Agents
- Sequestering Agents
- Iron Chelating Agents
- Deferasirox
Other Study ID Numbers
- CICL670AHU02
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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