Safety and Efficacy of Romiplostim in Immune Thrombocytopenia (ITP) in the " Real-life " : Result of the French Experience in 72 Adults (ATU-r)
The purpose of this study is to review the charts of the first 100 patients included in the french compassionate program including patients with Immune Thrombopenia receiving romiplostim.
|Study Design:||Observational Model: Cohort
Time Perspective: Retrospective
- Safety and Efficacy of Romiplostim in Immune Thrombocytopenia (ITP) [ Designated as safety issue: Yes ]
|Study Start Date:||January 2008|
|Study Completion Date:||August 2009|
|Primary Completion Date:||July 2008 (Final data collection date for primary outcome measure)|
- Subject has a diagnosis of ITP according to the American Society of Hematology guidelines (George et al., 1996).
- Subject is equal to or greater than 18 years of age.
- Before any study-specific procedure, the appropriate written informed consent must be obtained.
- Subject receiving romiplostim in the compassionate program
- Available follow-up of one-year
•Secondary ITP e.g: thrombopenia related to hepatitis C, HIV, Chronic Lymphocytic Leukemia...
The goal of this study is to review retrospectively the charts of the 100 first patients including in this program in France during the period of January 2008 and July 2008.