Behç
Conditions
Interventions
Double-blind, randomized.
Bosentan 2 x 125 vs placebo 6 months, follow up 2 more months
Sponsors
ErasmusMC
Eligibility
Inclusion criteria
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 ¡Ý 6.5 mmol/L. - WBC ¡Ý 3.0 x 109/L. - Neutrophils ¡Ý 1.5 x 109/L. - Platelets ¡Ý 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
Exclusion criteria: 1. Age 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.
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| - 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. | — |
Primary
| Measure | Time frame |
|---|---|
| - A decrease in the score in the BDCAF of > 10 in patients with BD with a BDCAF score of > 20 | — |
Contacts
Public ContactJ.A.M. Laar van
Erasmus University Medical Center Room D-419
Outcome results
None listed