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

Henri Mondor University Hospital

Status: Completed

Conditions: Thrombopenia

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT01013181

ATU Romiplostim registry

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

• Exclusion Criteria:

  • Secondary ITP