Efficacy and Safety of Subcutaneous Belimumab or Placebo in Addition of Rituximab in Persistent or Chronic Immune Thrombocytopenia

Recruiting Phase 3 Interventional Study
Primary Immune Thrombocytopenia (ITP)
Pivotal Trial This treatment is in the last trial phase before FDA approval. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
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At a Glance
Age
18 and older
Sex
Any
Trial phase
Phase 3
Study type
Interventional
Purpose
Treatment
Participants needed
132 (estimated)
Sponsor
Assistance Publique - Hôpitaux de Paris · Other
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About This Trial
Primary immune thrombocytopenia (ITP) is an autoimmune disease mainly mediated by autoreactive B cells and the presence of pathogenic anti-platelet auto-antibodies that enhance platelet destruction and impair platelet production. There are approximately 4,000 newly diagnosed ITP cases each year in France. For patients with a platelet count of less than 30x109/L and/or bleeding symptoms, corticoste…
Trial Locations
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Eligibility Criteria
Inclusion Criteria: 1. Age ≥ 18 years 2. Primary ITP defined according to the standard definition criteria (Rodeghiero, Blood 2008) 3. Previous response to corticosteroids and/or IgIV defined by a rise of platelet levels \> 30 x 109/L with at least a twofold increase from baseline levels followed b…
Contacts

Matthieu MAHEVAS, Professor of medicine

0 1 49 81 20 76

matthieu.mahevas@aphp.fr

CONTACT