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Efficacy of Steroid Versus Steroid Plus Cyclophosphamide for Severe Henoch-Schoenlein Purpura
This study is ongoing, but not recruiting participants.
Study NCT00190229   Information provided by Assistance Publique - Hôpitaux de Paris
First Received: September 13, 2005   Last Updated: March 13, 2007   History of Changes

September 13, 2005
March 13, 2007
September 2002
 
  • Birmingham Vasculitis Activity Score (BVAS)
  • Activity of the disease
Same as current
Complete list of historical versions of study NCT00190229 on ClinicalTrials.gov Archive Site
  • Chronic lesions (Vasculitis Damage Index)
  • Renal function at 12 months
  • Kidney survival at 12 months
  • Patient survival at 12 months
  • Blood pressure
  • Infections
  • Adverse events related to steroid or cyclophosphamide
Same as current
 
Efficacy of Steroid Versus Steroid Plus Cyclophosphamide for Severe Henoch-Schoenlein Purpura
CESAR (Randomized Therapeutic Study of Steroid vs. Steroid Plus Cyclosphosphamide for Severe Viscera Henoch-Schoenlein Purpura)

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.

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.

 
Interventional
Treatment, Randomized, Open Label, Active Control, Single Group Assignment, Safety/Efficacy Study
Henoch-Schoenlein Purpura
Drug: Cyclophosphamide
 
Pillebout E, Thervet E, Hill G, Alberti C, Vanhille P, Nochy D. Henoch-Schonlein Purpura in adults: outcome and prognostic factors. J Am Soc Nephrol. 2002 May;13(5):1271-8.

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Active, not recruiting
200
December 2007
 

Inclusion Criteria:

  • Patients with Henoch-Schoenlein purpura
  • Patient’s age > 18 years

Exclusion criteria:

  • Patient presenting a purpura rheumatoïd the diagnosis of which is confirmed by the histology presenting at least a visceral infringement(achievement) making consider the affection as engraves(burns)
  • of 18 or more years old Patient
  • Patient capable of understanding(including) the advantages and the risks of the try
  • Patient having given his assent lit in writing
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
France
 
NCT00190229
 
AOM01034, P011014
Assistance Publique - Hôpitaux de Paris
 
Principal Investigator: Eric THERVET, MD Assistance Publique - Hôpitaux de Paris
Assistance Publique - Hôpitaux de Paris
March 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP