NCT01013181CompletedNot Applicable
Safety and Efficacy of Romiplostim in Immune Thrombocytopenia (ITP) in the " Real-life " : Result of the French Experience in 72 Adults
Henri Mondor University Hospital0 sites100 target enrollmentStarted: January 2008Last updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 100
- Primary Endpoint
- Safety and Efficacy of Romiplostim in Immune Thrombocytopenia (ITP)
Study Overview
Brief Summary
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.
Detailed Description
Inclusion Criteria:
- 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
Exclusion Criteria:
•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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Retrospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Inclusion Criteria:
- •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.
Exclusion Criteria
- •Exclusion Criteria:
- •Secondary ITP
Outcomes
Primary Outcomes
Safety and Efficacy of Romiplostim in Immune Thrombocytopenia (ITP)
Secondary Outcomes
No secondary outcomes reported
Investigators
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