IgIV Plus Prednisone vs High-dose Dexamethasone for ITP

Study acronym: IVIORDEX
StatusUnknown
PhasePhase 3
Started

Record status This record was last updated September 11, 2023 (before its estimated April 9, 2025 completion). Its status may not reflect the trial's current state.

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Record History

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  1. Minor Changed Registry marked status Unknown (sponsor has not verified the record since Sep 2023); last known: Recruiting
  2. Minor Re-verified, no change to tracked fieldsv5
  3. Notable Trial status: Not Yet Recruiting to Recruitingv4 Show 5 more changesShow less
    • Start date changed from estimate of Jan 1, 2022 to Apr 7, 2022
    • Study sites: 0 to 1
    • Primary completion date: Jan 5, 2025 to Apr 9, 2025
    • Study completion date: Jul 5, 2026 to Oct 9, 2026
    • Eligibility criteria expanded, about 10 words
  4. Notable Start date: Oct 1, 2021 to Jan 1, 2022
    • Primary completion date: Oct 5, 2024 to Jan 5, 2025
    • Study completion date: Apr 5, 2025 to Jul 5, 2026
    v3
  5. Minor Re-verified, no change to tracked fieldsv2
  6. Minor Study First Submitted
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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 combination is therefore usually given in patients with platelets count \< 20 x 109/L and moderate to severe bleeding manifestations. Based on common practice in France and on French ITP guidelines, on average 50 % of patients with ITP and profound thrombocytopenia do actually receive IVIg (mostly during the initial phase of the disease) corresponding to approximately 1,500 ITP patients per year in France. Whereas IVIg is usually well tolerated, renal insufficiency and congestive heart failure may occur, moreover IVIg are costly and non-easily available with supply difficulties in many countries including France. High dose dexamethasone (DXM) (ie: 40 mg/d for 4 days) has recently emerged as a promising treatment for ITP. One recent meta-analysis as well as a controlled prospective trial suggest that the initial overall response was higher (\> 80 %) and the time to response was shorter with dexamethasone (DXM) 40 mg/d given for 4 days compared to standard prednisone. The investigators hypothesize that DXM could be a reasonable non-inferior alternative to IVIg, more convenient for patients with less adverse events and economically cost-effective for patients with moderate and severe bleeding manifestations.
Trial Details
NCT Number NCT04968899
Lead Sponsor Assistance Publique - Hôpitaux de Paris
Conditions
(from sponsor)
Immune Thrombocytopenia (ITP)
Related terms Purpura, Thrombocytopenic, Idiopathic
Enrollment 272 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov