Treatment of Early Systemic Sclerosis by Bosentan

NCT ID: NCT00226889

Last Updated: 2009-06-12

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-01-31
• Study Completion Date: 2009-06-30

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. Thirty adult patients with early SSc will be treated with the endothelin-1 antagonist bosentan for 6 months.Disease progression will be assessed.

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 activity og tissue fibroblasts. The proliferation and hyperactivity of the fibroblasts may be caused by enhanced production of several cytokins, among them endothelin-1.The activity of endothelin-1 has been shown to be increased both in the circulation and within skin lesions. Endothelin-1 has several distinct properties, among them profibrotic activity, inflammatory and vasoconstriction.Thus, the actions induced by endothelin-1 may be a potensial target for the therapy of SSc.

Thirty patients with early SSc, that is of less than 12 months duration will be offered six months of treatment with the oral dual endothelin-1 antagonist bosentan. Assessment of disease progression will be performed at 3, 6, 9. 12 and 24 months using clinical, histological and immunohistochemical methods.

Conditions

Systemic Sclerosis (Scleroderma)

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

bosentan

Intervention Type: DRUG

Eligibility 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 -

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Rikshospitalet University Hospital

OTHER

Sponsor Role: lead

Principal Investigators

Jan T Gran, Professor

Role: STUDY_DIRECTOR

department of rheumatology

Locations

Department of rheumatology, Rikshospitalet

Oslo, , Norway

Countries

Norway

Other Identifiers

EUDRACTNR.2004-000650-23

Identifier Type: -

Identifier Source: org_study_id