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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
Rikshospitalet University Hospital
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Systemic Sclerosis (Scleroderma) focused on measuring Scleroderma, Fibrosis, Therapy, Bosentan, Endothelin-1

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

First Posted
September 23, 2005
Last Updated
June 11, 2009
Sponsor
Rikshospitalet University Hospital
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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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