Bosentan (Tracleer®) in patients with Behçet*s disease: a Pilot Study.

Phase 2

Completed

• Conditions: Amantiades-Behcets disease; Behcets disease; 10027665

• Registration Number: NL-OMON31428
• Lead Sponsor: Academisch Medisch Centrum

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 13 May 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 20

Inclusion Criteria

1. Behcet disease (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.
3. Adequate birth control measures in women of childbearing age during and for 6 weeks after receiving the last administration.
4. 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.
5. Patient must be able to adhere to the study visit schedule and other protocol requirements.
6. 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. A.
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 Tracleer® 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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified