Dexamethasone: given orally at 40 mg per day for two cycles (days1-4, and days 11-14).
Dexamethasone: given orally at 40 mg per day for three cycles (days1-4, days 11-14, and days 21-24).
Study summary
Primary immune thrombocytopenia is an autoimmune disorder characterised by decreased platelet counts and increased bleeding risk. Corticosteroids have been the standard initial treatment of primary immune thrombocytopenia for more than 30 years. The aim of this randomized controlled trial is to compare the efficacy and safety of high-dose dexamethasone in treating new-diagnosed primary immune thrombocytopenia (ITP) in di-cycle and tri-cycle.
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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.
Primary outcome measure(s)
Sustained response — Month 6 Sustained response was defined as platelet count maintained above 30 × 10\^9/L with an absence of bleeding symptoms or no requirement for additional ITP treatment for six consecutive months following achievement of initial response. Complete response was defined as a platelet count of 100 × 10\^9 cells per L or higher and an absence of bleeding. Partial response was defined as a platelet count of 30×10\^9 cells per L or higher, but less than 100×10\^9 cells per L, and at least a doubling of the baseline platelet count and an absence of bleeding.
Trial sites (1)
Facility
City
Region
Status
Qilu hospital of Shandong university
Jinan
Shandong
Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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