Status:
TERMINATED
Granulocytapheresis in Psoriasis
Lead Sponsor:
EXcorLab GmbH
Collaborating Sponsors:
Membrana GmbH
Nikkiso Co. Ltd
Conditions:
Psoriasis
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
In a prospective, randomized, controlled, double-blinded, multicenter study, granulocytapheresis using a novel cellulose-based adsorber will be compared to control sham treatment (placebo). The effect...
Eligibility Criteria
Inclusion
- Moderate to severe plaque psoriasis with a PASI \>/=10
- Age \>/= 18 years
- Negative pregnancy test in woman of childbearing age acceptable method of contraception for both men and women
- Written informed consent that can be withdrawn at any time or for any reason
- Discontinuation of any systemic psoriasis treatment. Washout period of at least two weeks for prior systemic medications
- Only emollients for topical treatment
- No vaccinations for at least 14 days prior to first treatment
Exclusion
- Other forms of psoriasis (e.g., guttate, pustular, erythrodermic, palmoplantar etc.)
- History of ongoing uncontrolled bacterial, fungal or viral infection (including opportunistic infections); HIV positivity
- Pregnancy
- Clinically relevant thrombocytopenia or bleeding disorders
- WBC \<4.000 or \>12.000/µl
- Malignancy within the last five years (exception: successfully treated basal cell carcinoma or squamous cell carcinoma of the skin)
- Severe cardiac disorders, stroke, pulmonary disease within the last year
- Any medical condition that, in the judgment of the investigators, would jeopardize the patient's safety during the study
Key Trial Info
Start Date :
February 18 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2009
Estimated Enrollment :
4 Patients enrolled
Trial Details
Trial ID
NCT00714272
Start Date
February 18 2008
End Date
January 1 2009
Last Update
August 14 2020
Active Locations (2)
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1
University of Würzburg, Department of Medicine, Division of Nephrology, and Department of Dermatology
Würzburg, Bavaria, Germany, 97080
2
University of Göttingen, Department of Dermatology and Department of Nephrology and Rheumatology
Göttingen, Lower Saxony, Germany, 37075