Treatment of Early Systemic Sclerosis by Bosentan (TRANOS)
Primary Purpose
Systemic Sclerosis (Scleroderma)
Status
Terminated
Phase
Phase 1
Locations
Norway
Study Type
Interventional
Intervention
bosentan
Sponsored by
About this trial
This is an interventional treatment trial for Systemic Sclerosis (Scleroderma) focused on measuring Scleroderma, Fibrosis, Therapy, Bosentan, Endothelin-1
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 -
Sites / Locations
- Department of rheumatology, Rikshospitalet
Outcomes
Primary Outcome Measures
Overall clinical progression
Degree of deposition of ET-1 in skin
Secondary Outcome Measures
Development of extradermatological manifestations
Quality of life
Full Information
NCT ID
NCT00226889
First Posted
September 23, 2005
Last Updated
June 11, 2009
Sponsor
Rikshospitalet University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT00226889
Brief Title
Treatment of Early Systemic Sclerosis by Bosentan
Acronym
TRANOS
Study Type
Interventional
2. Study Status
Record Verification Date
March 2006
Overall Recruitment Status
Terminated
Why Stopped
failure of recruiting a sufficient number of patients
Study Start Date
January 2005 (undefined)
Primary Completion Date
January 2009 (undefined)
Study Completion Date
June 2009 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Rikshospitalet University Hospital
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Systemic Sclerosis (Scleroderma)
Keywords
Scleroderma, Fibrosis, Therapy, Bosentan, Endothelin-1
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
bosentan
Primary Outcome Measure Information:
Title
Overall clinical progression
Title
Degree of deposition of ET-1 in skin
Secondary Outcome Measure Information:
Title
Development of extradermatological manifestations
Title
Quality of life
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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 -
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jan T Gran, Professor
Organizational Affiliation
department of rheumatology
Official's Role
Study Director
Facility Information:
Facility Name
Department of rheumatology, Rikshospitalet
City
Oslo
ZIP/Postal Code
0026
Country
Norway
12. IPD Sharing Statement
Learn more about this trial
Treatment of Early Systemic Sclerosis by Bosentan
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