Treatment of Early Systemic Sclerosis by Bosentan

Systemic Sclerosis (Scleroderma) Clinical Trial

— TRANOS  

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00226889
• Other study ID #: EUDRACTNR.2004-000650-23
• Status: Terminated
• Phase: Phase 1/Phase 2
• First received: September 23, 2005
• Last updated: June 11, 2009
• Start date: January 2005
• Est. completion date: June 2009

Study information

• Verified date: March 2006
• Source: Rikshospitalet University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Norway: Norwegian Medicines Agency
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 30
• Est. completion date: June 2009
• Est. primary completion date: January 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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 -

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Scleroderma, Diffuse
• Scleroderma, Systemic
• Sclerosis
• Systemic Sclerosis (Scleroderma)

Intervention

Drug:
• bosentan

Locations

Country	Name	City	State
Norway	Department of rheumatology, Rikshospitalet	Oslo

Sponsors (1)

Lead Sponsor	Collaborator
Rikshospitalet University Hospital

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall clinical progression
Primary	Degree of deposition of ET-1 in skin
Secondary	Development of extradermatological manifestations
Secondary	Quality of life