Vaccine Response After Rituximab for Chronic, Severe Idiopathic Thrombocytopenic Purpura
Completed · Not applicable
Conditions studied: Idiopathic Thrombocytopenic Purpura, Immune Thrombocytopenic Purpura
In brief
The purpose of this study is to determine how children with a history of severe, chronic Idiopathic Thrombocytopenic Purpura (ITP) who were treated with rituximab might respond to vaccines. Eligible patients are previously or currently enrolled in a study entitled "Open Label, Phase I/II Trial of Rituximab for Chronic, Severe Idiopathic Thrombocytopenic Purpura in Children and Adolescents" and have decided to obtain an inactivated influenza vaccination. These patients will be invited to provide one blood sample prior to vaccination and a second sample following vaccination to quantify immune response to vaccination.
Key facts
- Study ID
- NCT01713855
- Run by
- Neufeld, Ellis J, MD, PhD
- People needed
- 10
- Starts
- 2004-10-01
- Expected to finish
- 2006-03-01
- Last updated by the study team
- 2012-10-25
Who can join
Age: 2 and older, up to 18. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Previously or currently enrolled in parent study, see CHB 02-12-160
You may not qualify if…
- Baseline immunodeficiency (i.e. DiGeorge syndrome, Common Variable Immunodeficiency)
- Contraindications for influenza vaccine, including: hypersensitivity to egg products; history of Guillain-Barre syndrome; history of adverse reaction to flu vaccine
- Contraindications for tetanus toxoid, including: hypersensitivity to prior tetanus vaccination; concurrent moderate to severe illness
- Subjects meeting any of the following criteria will be temporarily excluded from the study: high-dose corticosteroid therapy (5-30 mg/kg/day) during the 24 hours immediately prior to the vaccine; IVIG (intravenous immunoglobulin) within 4 months prior to vaccine; platelet count of less than 20,000/ml within one month of vaccination with evidence of grade II or higher skin bleeding, assessed at vaccine administration
Where it is running
- University of California, Los Angeles — Los Angeles, California, United States
- Emory University School of Medicine — Atlanta, Georgia, United States
- Children's Hospital — Boston, Massachusetts, United States
Full record on ClinicalTrials.gov
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