Treatment of Early Systemic Sclerosis by Bosentan

• Status: Terminated
• Trial end date: 2009-06-01
• Target enrollment: 0
• Participant gender: All

Summary

Systemic sclerosis (ssc) is characterised by extensive tissue fibrosis. Using drugs that are capable of inhibiting fibroblast activity may be beneficial if administrered early in the disease course. Thirty adult patients with early SSc will be treated with the endothelin-1 antagonist bosentan for 6 months.Disease progression will be assessed.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Rikshospitalet University Hospital
• Treatments: Bosentan

Criteria

Inclusion Criteria:

• Early systemic sclerosis

Exclusion Criteria:

• Age > 70 or < 18

• Pregnancy

• Nursing

• HIV

• Hb < 8.5 g/l

• Systolic blood pressure < 85 mmHg

• Lack of compliance

• Liver disease

• Hypersensitivity to bosentan

• Concurrent us of glibenclamide, ciclosporine A or tacrolimus -