D

Phase 1

• Conditions: Adult patients with immune thrombocytopenia (ITP) with mild to severe bleeding manifestations.; MedDRA version: 23.0Level: PTClassification code 10083842Term: Immune thrombocytopeniaSystem Organ Class: 10005329 - Blood and lymphatic system disorders; Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]

• Registration Number: EUCTR2021-000292-37-FR
• Lead Sponsor: ASSISTANCE PUBLIQUE-HOPITAUX DE PARIS

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2021-04-30
• Last Update Posted: 15 July 2024

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 272

Inclusion Criteria

- Age = 18 years = 80 years
- Diagnosis of ITP according to the standard definition
- Platelet count = 20 x 109/L
- Any cutaneous and/or any mucosal bleeding manifestations
- Normal marrow aspirate for patients aged of 60 and over
- Affiliated to a social security regime
- Written consent from patient

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range 190
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 82

Exclusion Criteria

- 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 (HIV, Viral hepatitis, herpes, varicella, zona)
- Uncontrolled diabetes
- 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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified