Intravenous Immunoglobulin Plus Oral Prednisone or High-dose Dexamethasone, for Adults With Immune Thrombocytopenia (ITP) With Moderate and Severe Bleeding: a Randomized, Multicentre Trial

Who is this study for? Adults with immune thrombocytopenia with moderate and severe bleeding
What treatments are being studied? Neofordex®
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 80
Healthy Volunteers: f
View:

• 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 regime

• Written consent from patient

Locations
Other Locations
France
Henri Mondor Hospital
RECRUITING
Créteil
Contact Information
Primary
Matthieu MAHEVAS, MD,PhD
matthieu.mahevas@aphp.fr
+33 (1) 49 81 20 76
Time Frame
Start Date: 2022-04-07
Estimated Completion Date: 2026-10-09
Participants
Target number of participants: 272
Treatments
Experimental: Experimental group
Oral dexamethasone (Neofordex®) 40 mg (Day1 to Day 4), ± an additional 4-days cycle of dexamethasone between days 10 and 21
Active_comparator: Control
IVIg (1g/kg D1-D2) plus prednisone (1 mg/kg/day x 21 days (3 weeks))
Sponsors
Leads: Assistance Publique - Hôpitaux de Paris

This content was sourced from clinicaltrials.gov