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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:
Collaborators:
Amgen
Paris 12 Val de Marne University
Information provided by:
Henri Mondor University Hospital
ClinicalTrials.gov Identifier:
NCT01013181
First received: November 12, 2009
Last updated: November 16, 2009
Last verified: November 2009
History of Changes
  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:

Drug Information available for: Romiplostim
U.S. FDA Resources

Further study details as provided by Henri Mondor University Hospital:

Primary Outcome Measures:
  • Safety and Efficacy of Romiplostim in Immune Thrombocytopenia (ITP) [ Designated as safety issue: Yes ]

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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

No publications provided by Henri Mondor University Hospital

Additional 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
Study First Received: November 12, 2009
Last Updated: November 16, 2009
Health Authority: France: Comité National Informatique et Liberté

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

Additional relevant MeSH terms:
Thrombocytopenia
Blood Platelet Disorders
Hematologic Diseases

ClinicalTrials.gov processed this record on May 23, 2013