Actively Recruiting
Intravenous Immunoglobulin Plus Oral Prednisone or High-dose Dexamethasone for Adults With Immune Thrombocytopenia (ITP) With Moderate and Severe Bleeding: a Randomized, Multicentre Trial
Led by Assistance Publique - Hôpitaux de Paris · Updated on 2023-09-11
272
Participants Needed
1
Research Sites
78 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying treatments for adults with Immune Thrombocytopenia (ITP) who have low platelet counts and moderate to severe bleeding symptoms. This study compares the combination of intravenous immunoglobulin (IVIg) plus prednisone to high-dose dexamethasone (DXM) to see if DXM can be a fast, reliable, and cost-effective alternative. The trial is randomized and multicenter, aiming to evaluate how quickly these treatments raise platelet counts and control bleeding. Participants will receive either oral dexamethasone 40 mg daily for 4 days, possibly with a second 4-day cycle between days 10 and 21, or intravenous immunoglobulin (1 g/kg on days 1 and 2) combined with oral prednisone (1 mg/kg daily for 3 weeks). These two treatment approaches are being compared for their effectiveness and safety in managing ITP with bleeding symptoms. During the study, participants will be monitored closely for their response to treatment, including the time to achieve initial and complete platelet count responses, bleeding events, and any side effects over a 6-month period. Researchers will assess platelet counts, bleeding symptoms, adverse events, and antibody status at various time points. The study will also track treatment switches and overall response durability to evaluate long-term outcomes and safety.
CONDITIONS
Brief Title
IgIV Plus Prednisone vs High-dose Dexamethasone for ITP
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 18 and 80 years
- Diagnosis of Immune Thrombocytopenia (ITP), newly diagnosed or relapsed
- Platelet count 20 x 10⁹/L or less
- Presence of any skin or mucosal bleeding symptoms
- Affiliated to a social security regime
- Provided written consent to participate
You will not qualify if you...
- Symptomatic COVID-19 infection
- Life-threatening bleeding such as intracranial hemorrhage or severe organ bleeding
- Current use of therapeutic anticoagulant treatments
- Previous non-response to intravenous immunoglobulin or dexamethasone
- More than 3 days of prednisone treatment at 1 mg/kg per day before enrollment
- Contraindications to intravenous immunoglobulin, prednisone, or dexamethasone
- Severe ongoing infections or uncontrolled viral infections including HIV or hepatitis
- Severe kidney or heart failure
- Uncontrolled diabetes with acidosis
- Untreated psychotic disorders
- Inability or refusal to understand or sign informed consent
- Legal restrictions such as judicial detention or legal protection
- Pregnancy, breastfeeding, or ineffective contraception
- Participation in another interventional trial recently or currently
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 3 to 4 weeks
Participants receive either oral dexamethasone for 4 to 8 days or intravenous immunoglobulin plus oral prednisone for 3 weeks.
1 baseline visit and weekly visits for up to 3 weeks
Duration - Up to 6 months
Participants are monitored for response and adverse events up to 6 months after treatment.
Periodic visits up to 6 months
Trial Site Locations
Total: 1 location
1
Henri Mondor Hospital
Créteil, France, 94010
Actively Recruiting
Research Team
M
Matthieu MAHEVAS, MD,PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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