Aspirin challenge of patients with systemic mastocytosis
Phase 1
- Conditions
- Systemic mastocytosis is a myeloproliferative disorder in which there is an accumulation of aberrant mast cells. It has various subtypes, ranging from indolent to aggressive mastocytosis. Symptoms can be divided into mast cell mediator-related (e.g. puritus, flushing, pyrosis, syncope, fatigue) and mast cell infiltration-related (e.g. hepatosplenomegaly, bone laesions and fractures).Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]
- Registration Number
- EUCTR2015-004604-37-NL
- Lead Sponsor
- Erasmus University Medical Center
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- Not specified
Inclusion Criteria
Systemic mastocytosis, according to WHO criteria.
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 91
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
Exclusion Criteria
Severe of uncontrolled asthma (FEV1<70%), nasal polyps, chronic rhinosinusitis, previous anaphylaxis due to NSAID's, patients who are not able to provide follow-up information, patients who are not deemed capable of handling possible delayed anaphylaxis at home.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method