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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT00171860 |
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Date of registration:
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13/09/2005 |
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Primary sponsor: |
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Public title:
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A Study to Determine the Safety and Efficacy of Imatinib Mesylate in Patients With Idiopathic Hypereosinophilic Syndrome
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Scientific title:
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A Study to Determine the Safety and Efficacy of Imatinib Mesylate in Patients With Idiopathic Hypereosinophilic Syndrome |
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Date of first enrolment:
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September 2002 |
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Target sample size:
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24 |
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Recruitment status: |
Terminated |
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URL:
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http://clinicaltrials.gov/show/NCT00171860 |
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Study type:
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Interventional |
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Study design:
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Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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Countries of recruitment
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Belgium
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Contacts
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Name:
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Novartis Pharmaceuticals |
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Address:
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Telephone:
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Email:
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Affiliation:
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Novartis Pharmaceuticals |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
Idiopathic hypereosinophilic syndromes are included provided they belong to one of the
following categories:
1. previously treated and showing documented resistance or refractoriness to, or
intolerance of, prednisone, hydroxyurea or interferon-alpha.
2. not previously treated but with documented Fip1L1-PDGFRA fusion protein
Exclusion Criteria:
- Other diseases associated with hypereosinophilia
- Serum creatinine, serum bilirubin, AST, ALT more than twice the upper normal limit.
- ECOG performance status >3
Other protocol-defined exclusion criteria may apply.
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Hypereosinophilic Syndrome
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Intervention(s)
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Drug: imatinib mesylate
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Primary Outcome(s)
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Rate of complete and partial response and relapse
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Secondary Outcome(s)
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Bone Marrow Analysis
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Disease-Related Symptoms and Signs
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Organ Involvement
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Peripheral blood detection of Fip1L1-PDGFRA tyrosine kinase
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Secondary ID(s)
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CSTI571ABE01
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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