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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01013181
First Posted: November 13, 2009
Last Update Posted: November 17, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
Amgen
Paris 12 Val de Marne University
Information provided by:
Henri Mondor University Hospital
  Purpose
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.

Condition
Thrombopenia

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Retrospective

Resource links provided by NLM:


Further study details as provided by Henri Mondor University Hospital:

Primary Outcome Measures:
  • Safety and Efficacy of Romiplostim in Immune Thrombocytopenia (ITP)

Enrollment: 100
Study Start Date: January 2008
Study Completion Date: August 2009
Primary Completion Date: July 2008 (Final data collection date for primary outcome measure)
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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients with primary Immune Thrombopenia receiving romiplostim in a compasionnate program
Criteria

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
  Contacts and Locations
No Contacts or Locations Provided
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Amgen Laboratory
ClinicalTrials.gov Identifier: NCT01013181     History of Changes
Other Study ID Numbers: ATU Romiplostim registry
First Submitted: November 12, 2009
First Posted: November 13, 2009
Last Update Posted: November 17, 2009
Last Verified: November 2009

Keywords provided by Henri Mondor University Hospital:
Immune Thrombopenia
Thrombocytopenia
romiplostim
compassionate program

Additional relevant MeSH terms:
Thrombocytopenia
Blood Platelet Disorders
Hematologic Diseases