Status:

TERMINATED

Treatment of Early Systemic Sclerosis by Bosentan

Lead Sponsor:

Rikshospitalet University Hospital

Conditions:

Systemic Sclerosis (Scleroderma)

Eligibility:

All Genders

18-70 years

Phase:

PHASE1

PHASE2

Brief 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. T...

Detailed Description

Systemic sclerosis (SSc) is characterised by obliterative vasculopathy and extensive fibrosis. The accumulation of extracellular components in the extracellular matrix is mostly due to increased activ...

Eligibility Criteria

Inclusion

  • Early systemic sclerosis

Exclusion

  • 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 -

Key Trial Info

Start Date :

January 1 2005

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

June 1 2009

Estimated Enrollment :

30 Patients enrolled

Trial Details

Trial ID

NCT00226889

Start Date

January 1 2005

End Date

June 1 2009

Last Update

June 12 2009

Active Locations (1)

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Page 1 of 1 (1 locations)

1

Department of rheumatology, Rikshospitalet

Oslo, Norway, 0026

Treatment of Early Systemic Sclerosis by Bosentan | DecenTrialz