The Study of Different Cycles of High-dose Dexamethasone in the Treatment of ITP

Launched by SHANDONG UNIVERSITY · Mar 30, 2025

Keywords

ClinConnect Summary

This clinical trial is looking at a treatment option for people with primary immune thrombocytopenia (ITP), a condition where the body doesn't make enough platelets, which are important for blood clotting. The study aims to compare how effective and safe high-dose dexamethasone, a type of steroid, is when given over two cycles versus three cycles. Dexamethasone has been used for over 30 years to help increase platelet counts and reduce bleeding risks in patients with ITP.

To participate in this trial, individuals must be at least 18 years old and have a confirmed diagnosis of newly diagnosed ITP with a low platelet count or bleeding symptoms. However, those with certain medical conditions, such as severe bleeding, recent blood clots, or specific infections, would not be eligible. Participants can expect to be closely monitored during the study to assess how well the treatment works and to check for any side effects. This trial is an important step in finding better treatment options for ITP, and it is not yet open for recruitment.

Gender

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Eligibility criteria

• Inclusion Criteria:
• • Participant must be at least 18 years of age at the time of the screening.
• • Participant may be male or female.
• • Participant has a confirmed diagnosis of newly diagnosed ITP according to the 2019 International Working Group assessment at screening, and has a baseline platelet count of less than 30 × 10\^9 cells per L or had bleeding manifestations, or both.
• Exclusion Criteria:
• • Participant has evidence of a secondary cause of immune thrombocytopenia (e.g. leukemia, lymphoma, common variable immune- deficiency, systemic lupus erythematosus, autoimmune thyroid disease, past medical history of untreated H. pylori infection) or to drug treatments (e.g. heparin, quinine, antimicrobials, anticonvulsants) or participant has a multiple immune cytopenia, e.g. Evan's syndrome.
• • Participant has clinically life-threatening bleeding (e.g. central nervous system bleeding, menorrhagia with significant drop in hemoglobin).
• • Participant has a history of coagulopathy disorders other than ITP.
• • Participant has a history of arterial or venous thromboembolism (e.g. stroke, transient ischemic attach, myocardial infarction, deep vein thrombosis or pulmonary embolism) within the 6 months prior to randomization or requires anticoagulant treatment.
• • Participant has 12-lead ECG with changes considered to be clinically significant upon medical review at baseline.
• • Participant has severe renal impairment (glomerular filtration rate less than 45ml/min/1.73 m2).
• • Participant has 3 × upper limit of normal of any of the following: alanine aminotransferase, aspartate aminotransferase, or alkaline phosphatase.
• • Participant with any of the following conditions: severe immunodeficiency, active or previous malignancy, human immunodeficiency virus (HIV), hepatitis B or C virus infection, pregnancy or lactation.