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

Thrombopenia Clinical Trial

— ATU-r  

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01013181
• Other study ID #: ATU Romiplostim registry
• Status: Completed
• Phase: N/A
• First received: November 12, 2009
• Last updated: November 16, 2009
• Start date: January 2008
• Est. completion date: August 2009

Study information

• Verified date: November 2009
• Source: Henri Mondor University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Comité National Informatique et Liberté
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: August 2009
• Est. primary completion date: July 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Thrombocytopenia
• Thrombocytosis
• Thrombopenia

Locations

Country	Name	City	State
n/a

Sponsors (3)

Lead Sponsor	Collaborator
Henri Mondor University Hospital	Amgen, Paris 12 Val de Marne University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety and Efficacy of Romiplostim in Immune Thrombocytopenia (ITP)			Yes