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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
272
Oral dexamethasone (Neofordex®) 40 mg (Day1 to Day 4), ± an additional 4-days cycle of dexamethasone between days 10 and 21.
IVIg (1g/kg D1-D2) plus oral prednisone (1 mg/kg/day x 21 days (3 weeks))
Henri Mondor Hospital
Créteil, France
RECRUITINGTime to achieve an initial response (R) within 5 days.
Time frame: 5 days
Time to achieve an initial complete response (CR) in the two arms
complete response (CR): defined by a platelet count \> 100 x 109/L in the absence use of any other ITP directed therapies between Day 1 and Day 5
Time frame: between Day 1 and Day 5
Duration of overall response from Day 1 to the end of the study in the two arms.
Time frame: Day 1 to 6 months
Proportion of early treatment switches across arms
Time frame: before day 5
Number of new bleeding manifestations between Day 1 and Day 5 in the two arms.
Time frame: between Day 1 and Day 5
Rates of response (R) and complete response (CR) in the two arms.
Time frame: at Day 28 and at 6 months
Number of new bleeding manifestations in the two arms.
Time frame: Between Day 5 and Day 28
Number of adverse events in the two arms.
Time frame: up to 6 months
Number of responders in patients with positive and negative anti-platelets antibodies in the two arms.
Time frame: At 6 months
Number of outcome in patients with positive and negative anti-platelets antibodies in the two arms.
Time frame: At 6 months
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