Safety and Efficacy of Romiplostim in Immune Thrombocytopenia (ITP) in the Real-life : Result of the French Experience in 72 Adults

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01013181

Acronym

ATU-r

Enrollment

100

Registered

2009-11-13

Start date

2008-01-31

Completion date

2009-08-31

Last updated

2009-11-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Thrombopenia

Keywords

Immune Thrombopenia, Thrombocytopenia, romiplostim, compassionate program

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Safety and Efficacy of Romiplostim in Immune Thrombocytopenia (ITP)	—

Outcome results