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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: |
NCT01713738 |
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Date of registration:
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18/10/2012 |
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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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Clinical Trial of Rituximab in Children and Adolescents With Chronic Idiopathic Thrombocytopenic Purpura (ITP)
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Scientific title:
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Open Label, Phase I/II Trial of Rituximab for Chronic, Severe Idiopathic Thrombocytopenic Purpura (ITP)in Children and Adolescents |
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Date of first enrolment:
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May 2003 |
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Target sample size:
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36 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT01713738 |
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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 1/Phase 2
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Countries of recruitment
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United States
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Contacts
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Name:
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Ellis J Neufeld, 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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Children's Hospital Boston |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
severe, chronic ITP, including refractory; at least 6 months from diagnosis for
refractory; at least 12 months from diagnosis for severe; platelet counts <10,000/mm3
twice in past 3 months without bleeding; platelet counts <20,000/mm3 twice in past 3
months with bleeding
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Exclusion Criteria:
ever had B or T cell neoplasm; HIV/AIDS; allergy to murine antibodies; treatment with
investigational immunosuppressive strategies within past 3 months -
Age minimum:
18 Months
Age maximum:
18 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Immune Thrombocytopenic Purpura (ITP)
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Idiopathic Thrombocytopenic Purpura (ITP)
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Intervention(s)
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Drug: rituximab
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Primary Outcome(s)
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platelet levels
[Time Frame: 9 - 12 weeks after 1st dose of rituximab]
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hypogammaglobulinemia
[Time Frame: over one year]
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Secondary Outcome(s)
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description of health-related quality of life
[Time Frame: over one year]
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fraction of responsive patients maintaining response over 1 year
[Time Frame: week 52]
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trend of bleeding scores throughout trial
[Time Frame: over one year]
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assessment of need for salvage therapy
[Time Frame: first 12 weeks of trial]
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rate of early response before day 57
[Time Frame: before day 57, and 4 additional weeks]
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Secondary ID(s)
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CHB 02-12-160
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Genentec/IDEC U2591S
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Glaser 435
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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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