NCT04968899 IgIV Plus Prednisone vs High-dose Dexamethasone for ITP
| NCT ID | NCT04968899 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Assistance Publique - Hôpitaux de Paris |
| Condition | Immune Thrombocytopenia (ITP) |
| Study Type | INTERVENTIONAL |
| Enrollment | 272 participants |
| Start Date | 2022-04-07 |
| Primary Completion | 2025-04-09 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 272 participants in total. It began in 2022-04-07 with a primary completion date of 2025-04-09.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility 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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT04968899 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 80 Years, studying Immune Thrombocytopenia (ITP). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT04968899 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 272 participants.
Is NCT04968899 currently recruiting?
Yes, NCT04968899 is actively recruiting participants. Contact the research team at matthieu.mahevas@aphp.fr for enrollment information.
Where is the NCT04968899 trial being conducted?
This trial is being conducted at Créteil, France.
Who is sponsoring the NCT04968899 clinical trial?
NCT04968899 is sponsored by Assistance Publique - Hôpitaux de Paris. The trial plans to enroll 272 participants.