Comparing IgIV with Prednisone to High-dose Dexamethasone for ITP
Intravenous Immunoglobulin Plus Oral Prednisone or High-dose Dexamethasone, for Adults With Immune Thrombocytopenia (ITP) With Moderate and Severe Bleeding: a Randomized, Multicentre Trial
This study is testing whether a combination of IVIg and prednisone works better than high-dose dexamethasone to quickly raise platelet counts in adults with ITP who have low platelets and are experiencing bleeding.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 272 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | Assistance Publique - Hôpitaux de Paris Academic / other |
| Drugs / interventions | prednisone |
| Locations | 1 site (Créteil) |
| Trial ID | NCT04968899 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the effectiveness of a combination treatment of intravenous immunoglobulin (IVIg) and prednisone versus high-dose dexamethasone in patients with immune thrombocytopenia (ITP) who have low platelet counts and active bleeding symptoms. The study aims to determine which treatment provides a more rapid and sustained increase in platelet counts. Patients eligible for the trial must be between 18 and 80 years old and have a platelet count of 20 x 10^9/L or lower, along with bleeding manifestations. The trial is conducted in France, where IVIg is commonly used for ITP patients.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 to 80 with a diagnosis of ITP and a platelet count of 20 x 10^9/L or lower.
Not a fit: Patients with life-threatening bleeding, severe renal insufficiency, or those currently on anticoagulation treatment may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a more effective and reliable option for patients with ITP experiencing severe bleeding.
How similar studies have performed: Previous studies have shown that IVIg is effective in treating ITP, making this approach a continuation of established practices rather than a novel or untested method.
Eligibility criteria
Show full inclusion / exclusion criteria
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 Exclusion Criteria: * 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 this trial is running
Créteil
- Henri Mondor Hospital — Créteil, France (Recruiting)
Study contacts
- Study coordinator: Matthieu MAHEVAS, MD,PhD
- Email: matthieu.mahevas@aphp.fr
- Phone: +33 (1) 49 81 20 76
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.