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Treatment of Early Systemic Sclerosis by Bosentan (TRANOS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00226889
Recruitment Status : Terminated (failure of recruiting a sufficient number of patients)
First Posted : September 27, 2005
Last Update Posted : June 12, 2009
Information provided by:
Rikshospitalet University Hospital

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.

Condition or disease Intervention/treatment Phase
Systemic Sclerosis (Scleroderma) Drug: bosentan Phase 1 Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Study Start Date : January 2005
Primary Completion Date : January 2009
Study Completion Date : June 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Scleroderma
Drug Information available for: Bosentan

Primary Outcome Measures :
  1. Overall clinical progression
  2. Degree of deposition of ET-1 in skin

Secondary Outcome Measures :
  1. Development of extradermatological manifestations
  2. Quality of life

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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 -

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00226889

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Department of rheumatology, Rikshospitalet
Oslo, Norway, 0026
Sponsors and Collaborators
Rikshospitalet University Hospital
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Study Director: Jan T Gran, Professor department of rheumatology
Layout table for additonal information Identifier: NCT00226889    
Other Study ID Numbers: EUDRACTNR.2004-000650-23
First Posted: September 27, 2005    Key Record Dates
Last Update Posted: June 12, 2009
Last Verified: March 2006
Keywords provided by Rikshospitalet University Hospital:
Additional relevant MeSH terms:
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Scleroderma, Systemic
Scleroderma, Diffuse
Pathologic Processes
Connective Tissue Diseases
Skin Diseases
Antihypertensive Agents
Endothelin Receptor Antagonists
Molecular Mechanisms of Pharmacological Action