EUCTR2009-013295-48-DKActive, not recruitingNot Applicable
Treatment of patients with Nephrogenic Systemic Fibrosis(NSF) with Imatinib Mesylate(Glivec). An open label clinical trial among patients with moderate to severe NSF.
Århus University Hospital, Department of Dermatology0 sitesStarted: July 21, 2009Last updated:
Drugs
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Sponsor
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- All
Inclusion Criteria
- •1.Age > 18 years
- •2.Diagnosed with NSF
- •3.mRodnan skinscore => 20 or
- •4.Rapid progression of the disease defined as a 50 % increase in mRodnan skin score in less than 7 weeks or
- •5.Progression of the fibrosis in the inner organs and
- •6.No absolute contraindications to the treatment.
- •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
- •Exclusion Criteria :
- •1.Known sensitivity to Imatinib Mesylate or to any of its components
- •2. Pregnant or lactating woman
- •3.ALAT > 3 x upper limit of normal
- •4. Severe congestive heart failure(NYHA Class III or IV)
Investigators
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