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Main
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Note: This record shows only the 20 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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28 January 2013 |
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Main ID: |
NCT00574652 |
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Date of registration:
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14/12/2007 |
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Primary sponsor: |
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Public title:
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Evaluation of Clinical Efficacy and Immunologic Response After IL-2 Therapy in HCV-related Vasculitis Patients
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Scientific title:
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ANRS HC 21 VASCU IL-2, Evaluation of the Cellular Immune Response, Clinical Efficacy and Tolerance After IL-2 Therapy in HCV-related Vasculitis Patients, Resistant to Conventional Therapy. |
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Date of first enrolment:
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March 2008 |
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Target sample size:
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10 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00574652 |
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Study type:
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Interventional |
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Study design:
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Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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Countries of recruitment
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France
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Contacts
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Name:
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Patrice Cacoub, MD, PHD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Hôpital de la Pitié, 83 Bd de l'Hôpital 75651 Paris cedex 13 |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
1. HCV+ patients with cryoglobulinemia Vasculitis
2. resistant to conventional therapy (i.e. antiviral therapy and/or immunosuppressors).
3. Vasculitis is defined according to international criteria: chronic HCV infection (HCV
RNA+),
4. serum cryoglobulin superior or equal to 0.05g/l in at least two determinations,
5. presence of the triad purpura-arthralgia-asthenia and/or biopsy proven Vasculitis
(kidney, nerve or skin).
Age minimum:
18 Years
Age maximum:
75 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Cryoglobulinemia Vasculitis
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Intervention(s)
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Drug: Proleukin
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Primary Outcome(s)
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Immunologic follow-up of Treg and of HCV cellular immune response before, during and after IL-2 therapy
[Time Frame: 9 months]
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Secondary Outcome(s)
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Clinical efficacy: follow-up of clinical manifestations of HCV-MC
[Time Frame: 9 months]
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Clinical tolerance: Absence of Vasculitis flare during and after IL-2 therapy
[Time Frame: 9 months]
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Secondary ID(s)
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2006-004039-31
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ANRS HC 21 Vascu-IL2
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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