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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01013181
Other study ID # ATU Romiplostim registry
Secondary ID
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


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
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