IgIV Plus Prednisone vs High-dose Dexamethasone for ITP

Recruiting Phase 3 Interventional Study
Immune Thrombocytopenia (ITP)
No Placebo Group Every participant receives an active treatment — no one gets a placebo. 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 – 80
Sex
Any
Trial phase
Phase 3
Study type
Interventional
Purpose
Treatment
Participants needed
272 (estimated)
Sponsor
Assistance Publique - Hôpitaux de Paris · Other
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About This Trial
ITP patients with low platelet count and active bleeding symptoms are at risk of life-threatening bleeding and therefore require a treatment with a rapid effect, reliable, and sustained. The combination of intravenous immunoglobulin (IVIg) and prednisone (1 mg/kg per day), is more rapidly and more frequently effective than high dose methylprednisolone to increase the platelet count. This combinati…
Trial Locations
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Eligibility Criteria
Inclusion Criteria: * Age ≥ 18 years ≤ 80 years * Diagnosis of ITP whatever the duration of the disease (newly diagnosed or relapsed) according to the standard definition * Platelet count ≤ 20 x 109/L * Any cutaneous and/or any mucosal bleeding manifestations * Affiliated to a social security regim…
Contacts

Matthieu MAHEVAS, MD,PhD

+33 (1) 49 81 20 76

matthieu.mahevas@aphp.fr

CONTACT