Status:
NOT_YET_RECRUITING
The Study of Different Cycles of High-dose Dexamethasone in the Treatment of ITP
Lead Sponsor:
Shandong University
Conditions:
Thrombocytopenia
Eligibility:
All Genders
18+ years
Phase:
PHASE2
PHASE3
Brief 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 im...
Detailed Description
In this multicentre, open-label, randomized controlled trial, about 118 new-diagnosed ITP patients will be enrolled from five tertiary medical centres in China. Eligible participants are randomly assi...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
May 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 30 2027
Estimated Enrollment :
118 Patients enrolled
Trial Details
Trial ID
NCT06913374
Start Date
May 1 2025
End Date
May 30 2027
Last Update
April 8 2025
Active Locations (1)
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1
Qilu hospital of Shandong university
Jinan, Shandong, China, 273300