Ignite Creation Date:
2024-05-05 @ 12:03 PM
Last Modification Date:
2024-10-26 @ 9:19 AM
Study NCT ID:
NCT00226889
Status:
TERMINATED
Last Update Posted:
2009-06-12
First Post:
2005-09-23
Brief Title:
Treatment of Early Systemic Sclerosis by Bosentan
Sponsor:
Rikshospitalet University Hospital
Organization:
Rikshospitalet University Hospital
Study Overview
Official Title:
None
Status:
TERMINATED
Status Verified Date:
2006-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
failure of recruiting a sufficient number of patients
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
TRANOS
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 monthsDisease 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-1The 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 vasoconstrictionThus 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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None