Informations générales (source: ClinicalTrials.gov)
Intravenous Immunoglobulin Plus Oral Prednisone or High-dose Dexamethasone, for Adults With Immune Thrombocytopenia (ITP) With Moderate and Severe Bleeding: a Randomized, Multicentre Trial (IVIORDEX)
Interventional
Phase 3
Assistance Publique - Hôpitaux de Paris (Voir sur ClinicalTrials)
avril 2022
octobre 2026
29 juin 2024
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.
Etablissements
| Les établissements d'Île-de-France ayant mis à jour leurs données Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| AP-HP - Hôpital Bicêtre | MAHEVAS Matthieu | 18/04/2025 07:55:25 | Contacter | ||
| AP-HP - Hôpital Bichat | MAHEVAS Matthieu | 18/04/2025 07:55:25 | Contacter | ||
| AP-HP - Hôpital Cochin | MAHEVAS Matthieu | 18/04/2025 07:55:25 | Contacter | ||
| AP-HP - Hôpital Europeen Georges Pompidou | MAHEVAS Matthieu | 18/04/2025 07:55:25 | Contacter | ||
| AP-HP - Hôpital Henri Mondor-Albert Chenevier | MAHEVAS Matthieu | 18/04/2025 07:55:25 | Contacter | ||
| AP-HP - Hôpital La Pitié-Salpêtrière | MAHEVAS Matthieu | 18/04/2025 07:55:25 | Contacter | ||
| AP-HP - Hôpital Lariboisiere-Fernand Widal | MAHEVAS Matthieu | 18/04/2025 07:55:25 | Contacter | ||
| AP-HP - Hôpital Saint Antoine | MAHEVAS Matthieu | 18/04/2025 07:55:25 | Contacter | ||
| CHI DE CRETEIL | Guillaume BONNARD | 29/03/2024 01:30:21 | Contacter | ||
| HOPITAL FOCH | MATHILDE ROUMIER | 05/05/2025 07:12:10 | Contacter | ||
Critères
Tous
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 regime
- Written consent from patient
- 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
- 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.