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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.   Last updated on March 13, 2007.   Information provided by Assistance Publique - Hôpitaux de Paris

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Descriptive Information Fields
Brief Title  Efficacy of Steroid Versus Steroid Plus Cyclophosphamide for Severe Henoch-Schoenlein Purpura
Official Title  CESAR (Randomized Therapeutic Study of Steroid vs. Steroid Plus Cyclosphosphamide for Severe Viscera Henoch-Schoenlein Purpura)
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 Phase
Study Type  Interventional
Study Design  Treatment, Randomized, Open Label, Active Control, Single Group Assignment, Safety/Efficacy Study
Primary Outcome Measure  Birmingham Vasculitis Activity Score (BVAS)
Activity of the disease
Secondary Outcome Measure  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
Condition  Henoch-Schoenlein Purpura
Intervention  Drug: Cyclophosphamide
MEDLINE PMIDs 11961015
Links
Recruitment Information Fields
Recruitment Status  Active, not recruiting
Enrollment  200
Start Date  September 2002
Completion Date December 2007
Eligibility Criteria 

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
Gender Both
Ages 18 Years and older
Accepts Healthy Volunteers No
Contacts ††
Location Countries  France
Administrative Information Fields
NCT ID  NCT00190229
Organization ID AOM01034
Secondary IDs †† P011014
Study Sponsor  Assistance Publique - Hôpitaux de Paris
Collaborators ††
Investigators 
Principal Investigator:     Eric THERVET, MD     Assistance Publique - Hôpitaux de Paris    
Information Provided By Assistance Publique - Hôpitaux de Paris
Verification Date March 2007
First Received Date  September 13, 2005
Last Updated Date March 13, 2007

 †    Required WHO trial registration data element.
††   WHO trial registration data element that is required only if it exists.




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