Treatment of Early Systemic Sclerosis by Bosentan (TRANOS)
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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 |
- Overall clinical progression
- Degree of deposition of ET-1 in skin
- 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) |
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 |
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 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 May 23, 2013