|- candidate number||3566|
|- NTR Number||NTR1372|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||8-jul-2008|
|- Secondary IDs||2008-042 METC Erasmus MC Rotterdam|
|- Public Title||Tracleer in Behçet's disease |
|- Scientific Title||Bosentan (Tracleer) in patients with Behçet's disease: a Pilot Study.|
|- hypothesis||Therapeutic effect of bosentan in patients with Behçet's disease due to antiinflammatory effects on the vascular wall.
|- Healt Condition(s) or Problem(s) studied||Vasculitis, BehÁet's disease, Bosentan, Endothelin-1 (ET-1)|
|- Inclusion criteria||1. BD patients classified according to the criteria according to the International study group for BD |
2. BD patients not responding to their usual therapy (BDCAF > 20)
3. Non life-or sight threatening active disease.
4. Adequate birth control measures in women of childbearing age during and for 6 weeks after receiving the last administration.
5. The screening laboratory test results must meet the following criteria:
- Hemoglobin °› 6.5 mmol/L.
- WBC °› 3.0 x 109/L.
- Neutrophils °› 1.5 x 109/L.
- Platelets °› 100 x 109/L.
- SGOT (AST), SGPT (ALT) and alkaline phosphatase levels must be within 3 times the upper limit of normal (ULN) range for the laboratory conducting the test.
- Creatinine clearance > 20 ml/min.
6. Patient must be able to adhere to the study visit schedule and other protocol requirements.
7. The patient must be capable of giving informed consent and the consent must be obtained prior to any screening procedures.
|- Exclusion criteria||1. Age < 18 years.|
2. Women who are pregnant, nursing, or planning pregnancy within 38 weeks after enrollment.
3. Hypotension, defined as systolic blood pressure less than 85 mm Hg
4. Use of any of the following drugs: glybenclamide, calcineurin inhibitors (eg, cyclosporine A, tacrolimus) or fluconazole. Attention must be focused on liverenzymes and adverse effects if the patient uses other drugs that interfere with CYP-450 isoenzymes such as listed in paragraph 11.
5. Use of any investigational drug within 1 month prior to screening or within 5 half-lives of the investigational agent, whichever is longer.
6. Liver enzymes > 3 times the ULN, Creatinine clearance of < 20ml/min.
7. Patients with known hypersensitivity to Bosentan or to drugs with similar chemical structures.
8. Current signs or symptoms of severe, progressive or uncontrolled renal, hepatic, hematological, gastrointestinal, endocrine, pulmonary, cardiac, neurological, infectious or cerebral disease.
9. Malignancy within the past 5 years (except for treated squamous or basal cell carcinoma of the skin without evidence of recurrence).
10. Known recent substance abuse (drugs or alcohol).
11. Poor tolerability of venipuncture or lack of adequate venous access for required blood sampling during the study period.
|- mec approval received||yes|
|- multicenter trial||no|
|- Type||2 or more arms, randomized|
|- planned startdate ||1-sep-2008|
|- planned closingdate||1-okt-2010|
|- Target number of participants||20|
|- Interventions||Double-blind, randomized. |
Bosentan 2 x 125 vs placebo 6 months, follow up 2 more months
|- Primary outcome||- A decrease in the score in the BDCAF of > 10 in patients with BD with a BDCAF score of > 20|
|- Secondary outcome||- ET-1 levels in relation with BDCAF.|
- Study of cytokine patterns in relation with therapy and BDCAF.
- T cell patterns in relation with therapy and BDCAF.
|- Timepoints||Week 0, 4, 8, 12, 16, 20, 24, 28, 32|
|- Trial web site||N/A|
|- CONTACT FOR PUBLIC QUERIES|| J.A.M. Laar van|
|- CONTACT for SCIENTIFIC QUERIES|| J.A.M. Laar van|
|- Sponsor/Initiator ||Erasmus Medical Center|
(Source(s) of Monetary or Material Support)
|Actelion Pharmaceuticals |
|- Brief summary||Patients with Behcet's disease refractory for immunosuppressive therapy (BDCAF >20) are randomized for add on treatment with bosentan for 6 months. Therapeutic efficacy will be measured with a standarized activity scoring system (BDCAF), and analyzed with secundary parameters such as ET-1 levels, cytokines and Tcell functionality.|
|- Main changes (audit trail)|
|- RECORD||8-jul-2008 - 25-jul-2008|