IgIV Plus Prednisone vs High-dose Dexamethasone for ITP

Recruiting now · Phase 3

Conditions studied: Immune Thrombocytopenia (ITP)

In brief

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.

Key facts

Study ID: NCT04968899
Run by: Assistance Publique - Hôpitaux de Paris
People needed: 272
Starts: 2022-04-07
Expected to finish: 2026-10-09
Last updated by the study team: 2023-09-11

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

Symptomatic COVID-19 disease
Life-threatening bleeding defined as Intracranial hemorrhage and/or active organ bleeding (GI tract, urinary tract or menorrhagia with at least a 2 g/dl decrease of hemoglobin value from baseline).
Ongoing anticoagulation treatment (Therapeutic Low molecular weight heparins (LMWHs), direct oral anticoagulants (DOACs) and vitamin K antagonists (VKAs))
Previous non-response to IVIg or DEX
Treatment with prednisone (1 mg/kg per day) for more than 3 days
Any, contraindications to the prescribed Ig IV or prednisone patent medicine and to Neofordex®
Ongoing severe infection
Severe Renal insufficiency (DFG < 45 ml.min.1.73m2)
Severe Cardiac insufficiency (FEVG < 30 %)
Ongoing viral infection (uncontrolled HIV, Viral hepatitis, herpes, varicella, zona).
Uncontrolled diabetes (Acido-cetosis)
Psychotic state not yet controlled by treatment
Inability or refusal to understand or refusal to sign the informed consent from study participation
Persons deprived of their liberty by judicial or administrative decision,
Persons under legal protection (guardianship, curatorship)
Pregnant or breastfeeding woman or ineffective contraception
Participation in another interventional study involving human participants or being in the exclusion period at the end of a previous study involving human participants.

Where it is running

Henri Mondor Hospital — Créteil, France (enrolling)

Full record on ClinicalTrials.gov

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