Comparing Oral Dexamethasone and Intravenous Immunoglobulin Plus Prednisone for Adults With Immune Thrombocytopenia and Moderate to Severe Bleeding

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 gkg on days 1 and 2 combined with oral prednisone 1 mgkg 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.

IgIV Plus Prednisone vs High-dose Dexamethasone for ITP