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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: |
NCT01101295 |
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Date of registration:
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05/04/2010 |
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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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The ITP-RITUX Cohort: Rituximab in Immune ThrombocytoPenia.
ITP-RITUX |
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Scientific title:
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The ITP-RITUX Cohort: An Observational Study on Rituximab Off-label Use for Immune ThrombocytoPenia. |
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Date of first enrolment:
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April 2010 |
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Target sample size:
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250 |
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Recruitment status: |
Recruiting |
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URL:
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http://clinicaltrials.gov/show/NCT01101295 |
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Study type:
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Observational |
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Study design:
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Observational Model: Cohort, Time Perspective: Prospective
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Phase:
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N/A
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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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Bertrand GODEAU, 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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National Reference Center for Study of Cytopenia |
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Name:
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Bertrand GODEAU, MD |
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Address:
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Telephone:
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0033149812900 |
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Email:
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bertrand.godeau@hmn.aphp.fr |
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Affiliation:
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- ITP diagnosis according to the American Society of Hematology society
- Secondary ITP if the underlying disease is an autoimmune disease(Lupus,Sjogren..)
Exclusion Criteria:
- Previous treatment by rituximab
- Secondary ITP associated to a hematologic disease (Chronic Lymphocytic Leukemia,
Hodgkin Disease...)
- Secondary ITP associated to a chronic infectious disease (Hepatitis B, C, HIV)
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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Purpura, Thrombocytopenic, Idiopathic
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Autoimmune Thrombocytopenia
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Primary Outcome(s)
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Occurrence of a serious adverse events (clinical or biological events)
[Time Frame: 5 years]
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Secondary Outcome(s)
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Impact of rituximab on the natural history of ITP
[Time Frame: 5 years]
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Modality of the administration of rituximab
[Time Frame: 5 years]
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Evaluation of the Platelet count evolution
[Time Frame: 5 years]
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Rate of splenectomy in the cohort
[Time Frame: 5 years]
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Characteristics of the patients receiving Rituximab
[Time Frame: 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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