Ignite Creation Date:
2024-05-05 @ 11:57 AM
Last Modification Date:
2024-10-26 @ 9:17 AM
Study NCT ID:
NCT00190229
Status:
COMPLETED
Last Update Posted:
2011-05-04
First Post:
2005-09-13
Brief Title:
Efficacy of Steroid Versus Steroid Plus Cyclophosphamide for Severe Henoch-Schoenlein Purpura
Sponsor:
Assistance Publique - Hôpitaux de Paris
Organization:
Assistance Publique - Hôpitaux de Paris
Study Overview
Official Title:
CESAR Randomized Therapeutic Study of Steroid vs Steroid Plus Cyclosphosphamide for Severe Viscera Henoch-Schoenlein Purpura
Status:
COMPLETED
Status Verified Date:
2007-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Henoch-Schonlein purpura is a leucocytoclastic systemic vasculitis involving small vessels with the deposition of immune complexes containing IgA It is characterized by the association of skin joint and gastrointestinal manifestations Even though the evolution is usually simple some patients especially adults may have severe visceral involvement including heart lung brain and renal disease The best treatment is currently unknown This study will test the safety and efficacy of steroids associated or not with cyclosphosphamide to treat the acute lesions and to prevent the development of chronic lesions
Detailed Description:
The protocol test the role of 2 modalities of treatment steroid vs steroid and cyclophosphamide for severe systemic form of Henoch-Schonlein purpura The severe forms include extracapillary glomerulonephritis myocarditis pneumonitis occult involvement severe gastro-intestinal bleeding No other randomized trial has been performed in adult patient for this indication
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