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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 February 2015 |
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Main ID: |
NCT00399399 |
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Date of registration:
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13/11/2006 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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CHUSPAN SCS BP Treatment of Churg–Strauss Syndrome Without Poor-Prognosis Factors
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Scientific title:
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CHUSPAN SCS BP Treatment of Churg–Strauss Syndrome Without Poor-Prognosis Factors: a Prospective Randomized Study in 72 Patients. |
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Date of first enrolment:
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July 1996 |
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Target sample size:
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72 |
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Recruitment status: |
Active, not recruiting |
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URL:
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http://clinicaltrials.gov/show/NCT00399399 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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Phase:
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Phase 4
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Countries of recruitment
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Switzerland
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Contacts
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Name:
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Jean-François Cordier, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Hospices Civils de Lyon |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Men and women with newly diagnosed Churg-Strauss syndrome;
- absence of poor prognostic factors as defined by the five-factor score (serum
creatinine > 140 µmol/l or 1.58 mg/dl, proteinuria > 1 g/day, severe gastrointestinal
tract involvement, specific cardiomyopathy and/or central nervous system involvement;
- written informed consent.
Exclusion Criteria:
- age < 15 years, previously treated Churg-Strauss syndrome;
- history of cancer;
- pregnant or breast-feeding women;
- psychiatric disorders that might compromise compliance with therapy;
- contraindication to study drug;
- other ongoing therapeutic trial;
- concomitant viral hepatitis B or C or human immunodeficiency virus (HIV) infection
Age minimum:
15 Years
Age maximum:
90 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Churg-Strauss Syndrome
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Intervention(s)
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Drug: azathioprine
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Drug: cyclophosphamide
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Primary Outcome(s)
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Number of events (failures, relapses and/or deaths) occurring in each group, defining the disease-free survival rate, measured at study end (mean follow-up of 5 years)
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Secondary Outcome(s)
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Overall survival, relapse rate and adverse events, measured at study end (mean follow-up of 5 years)
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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