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OpenTrials
Completed

NCT Number: NCT01013181

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

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.

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Key information

Conditions

Thrombopenia Blood Platelet Disorders Cytopenia Hematologic Diseases Hemic and Lymphatic Diseases Thrombocytopenia

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Safety and Efficacy of Romiplostim in Immune Thrombocytopenia (ITP)

Sponsors and collaborators

Lead sponsor

Henri Mondor University Hospital

Other

Collaborators

  • Amgen
  • Paris 12 Val de Marne University

Registry information

Acronym: ATU-r

Important dates

Study start
2008
Primary completion
2008
Study completion
2009
First posted
Nov 13, 2009
Registry last updated
Nov 17, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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