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Purpura, Thrombocytopenic, Idiopathic | The ITP-RITUX Cohort: Rituximab in Immune ThrombocytoPenia.

Purpura, Thrombocytopenic, Idiopathic research study

What is the primary objective of this study?

The primary purpose of the study is to describe by a prospective observational study the serious adverse events occurring in patients treated off-label by rituximab for Immune Thrombocytopenia.

Who is eligible to participate?

Inclusion Criteria: - ITP diagnosis according to the American Society of Hematology society - Secondary ITP if the underlying disease is an autoimmune disease(Lupus,Sjogren..) Exclusion Criteria: - Previous treatment by rituximab - Secondary ITP associated to a hematologic disease (Chronic Lymphocytic Leukemia, Hodgkin Disease...) - Secondary ITP associated to a chronic infectious disease (Hepatitis B, C, HIV)

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

Purpura, Thrombocytopenic, Idiopathic

Autoimmune Thrombocytopenia

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

Study Status

Unknown status

Start Date: April 2010

Completed Date: April 2017

Phase: N/A

Type: Observational

Design:

Primary Outcome: Occurrence of a serious adverse events (clinical or biological events)

Secondary Outcome: Impact of rituximab on the natural history of ITP

Study sponsors, principal investigator, and references

Principal Investigator: Bertrand GODEAU, MD

Lead Sponsor: Henri Mondor University Hospital

Collaborator: Roche Pharma AG

More information:https://clinicaltrials.gov/show/NCT01101295

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