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Note: This record shows only 22 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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EUCTR |
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Last refreshed on:
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19 March 2012 |
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Main ID: |
EUCTR2006-007091-15-NL |
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Date of registration:
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02/04/2007 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Glivec (imatinib mesylate) in systemic sclerosis, a pilot study - Glivec in systemic sclerosis
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Scientific title:
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Glivec (imatinib mesylate) in systemic sclerosis, a pilot study - Glivec in systemic sclerosis |
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Date of first enrolment:
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03/09/2007 |
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Target sample size:
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10 |
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Recruitment status: |
Authorised-recruitment may be ongoing or finished |
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URL:
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https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2006-007091-15 |
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Study type:
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Interventional clinical trial of medicinal product |
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Study design:
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Controlled: no
Randomised:
Open:
Single blind:
Double blind:
Parallel group:
Cross over:
Other:
If controlled, specify comparator, Other Medicinial Product:
Placebo:
Other:
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Phase:
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Countries of recruitment
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Netherlands
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Contacts
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Affiliation:
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Key inclusion & exclusion criteria
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Inclusion criteria:
· Patients with systemic sclerosis (either diffuse or limited) refractory to standard therapy
· Adequate end organ function, defined as: total bilirubin <1.5 x ULN, SGOT and SGPT < 2.5 x ULN (or <5 x ULN if hepatic disease involvement is present), creatinine < 1.5 x ULN, ANC >1.5 x 109/L, platelets > 100 x 109/L.
· Adequate anticonception in women
· Written informed consent
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
Exclusion criteria:
· Age < 18 years
· Previous or current malignancy
· Current treatment with endothelin receptor antagonist
· Current treatment with immunosuppressive drugs
· Life expectancy < 6 months
· Pregnancy
· Inability to adhere to the current protocol
Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes
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Health Condition(s) or Problem(s) studied
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systemic sclerosis
MedDRA version: 9.1
Level: LLT
Classification code 10039710
Term: Scleroderma
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Intervention(s)
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Product Name: Glivec
Pharmaceutical Form: Capsule*
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Primary Outcome(s)
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Main Objective: To investigate the efficacy (and the toxicity) of Glivec in systemic sclerosis by examining clinical outcomes (clinical and laboratory findings).
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Secondary Objective:
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Primary end point(s): Rodnan skin score
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Secondary ID(s)
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CSTI571ENL18
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Source(s) of Monetary Support
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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