an open-label study to evaluate safety and efficacy of 750 mg intravenous mepolizumab in subjects with steroid refractory eosinophilic cystitis
Phase 1
- Conditions
- eosinophilic cystitis
- Registration Number
- EUCTR2008-002353-20-BE
- Lead Sponsor
- Z Gasthuisberg
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Male
- Target Recruitment
- 1
Inclusion Criteria
steroid-dependent eosinophilic cystitis
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) no
F.1.3.1 Number of subjects for this age range
Exclusion Criteria
life threatening or other serious illness
serum creatinine > 3 ULN
AST or ALT > 5 ULN
platelets count < 50000/µL
left ventricular ejection fraction < 20%
positive pregnancy test
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