Treatment of Early Systemic Sclerosis by Bosentan (TRANOS)

This study has been terminated.
(failure of recruiting a sufficient number of patients)
Sponsor:
Information provided by:
Rikshospitalet University Hospital
ClinicalTrials.gov Identifier:
NCT00226889
First received: September 23, 2005
Last updated: June 11, 2009
Last verified: March 2006
  Purpose

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 Intervention Phase
Systemic Sclerosis (Scleroderma)
Drug: bosentan
Phase 1
Phase 2

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

Resource links provided by NLM:


Further study details as provided by Rikshospitalet University Hospital:

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

Secondary Outcome Measures:
  • Development of extradermatological manifestations
  • Quality of life

Estimated Enrollment: 30
Study Start Date: January 2005
Estimated Study Completion Date: June 2009
Estimated Primary Completion Date: January 2009 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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 -
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00226889

Locations
Norway
Department of rheumatology, Rikshospitalet
Oslo, Norway, 0026
Sponsors and Collaborators
Rikshospitalet University Hospital
Investigators
Study Director: Jan T Gran, Professor department of rheumatology
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00226889     History of Changes
Other Study ID Numbers: EUDRACTNR.2004-000650-23
Study First Received: September 23, 2005
Last Updated: June 11, 2009
Health Authority: Norway: Norwegian Medicines Agency

Keywords provided by Rikshospitalet University Hospital:
Scleroderma
Fibrosis
Therapy
Bosentan
Endothelin-1

Additional relevant MeSH terms:
Scleroderma, Systemic
Scleroderma, Diffuse
Sclerosis
Connective Tissue Diseases
Skin Diseases
Pathologic Processes
Bosentan
Antihypertensive Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 28, 2014