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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: |
NCT00907751 |
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Date of registration:
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22/05/2009 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Rituximab in Adult Acquired Idiopathic Thrombotic Thrombocytopenic Purpura
PTTritux |
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Scientific title:
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Association of Rituximab to Plasma Exchange in Adult Acquired Idiopathic Thrombotic Thrombocytopenic Purpura |
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Date of first enrolment:
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May 2010 |
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Target sample size:
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12 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00907751 |
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Study type:
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Interventional |
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Study design:
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Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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Phase:
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Phase 2
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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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Paul COPPO, Md Ph D |
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Address:
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Telephone:
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Email:
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Affiliation:
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Assistance Publique - Hôpitaux de Paris |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Microangiopathic hemolytic anemia (< 12 g/dL) with thrombocytopenia <50 G/L, and mild
or no renal failure (Serum creatinine < 150 µmol/L),
- negative Beta HCG and ongoing contraception during treatment and during the 24 months
following the last infusion of rituximab,
- refractory TTP (after 4 days of standard treatment)
- > 18 year old
- and signed written informed consent.
Exclusion Criteria:
- Hemolytic uremic syndrome (platelet count ³ 50 G/L and serum creatinine ³ 150
micromol/L),
- TTP associated with another condition (HIV infection, cancer and/or chemotherapy,
transplantation),
- previous treatment with vincristine or cyclophosphamide or other immunomodulatory
drugs (except steroids), within 2 months before inclusion ;
- ongoing or planned pregnancy, lactation
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Thrombotic Thrombocytopenic Purpura
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Intervention(s)
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Drug: rituximab
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Primary Outcome(s)
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To evaluate the kinetics of B-cell depletion by rituximab and its pharmacokinetics in patients treated with rituximab in association with plasma exchanges
[Time Frame: at 1, 3, 6, 9, 12, 18 and 24 months]
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Secondary Outcome(s)
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To evaluate the incidence of persistent severe acquired ADAMTS13 deficiency following treatment with rituximab, as well as the incidence of relapses.
[Time Frame: at 1, 3, 6, 9, 12, 18 and 24 months]
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To evaluate the tolerance of rituximab, the volume of plasma and the number of plasma exchange sessions required to achieve a durable complete remission, and to determinate the duration of B-cell depletion
[Time Frame: at 1, 3, 6, 9, 12, 18 and 24 months]
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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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