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.
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