The Study of Different Cycles of High-dose Dexamethasone in the Treatment of ITP
ConditionThrombocytopenia
Trial statusNot yet recruiting
Trial phasePhase 2, Phase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorShandong University
About this trial
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 criteria
Qualifiers
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.
Disqualifiers
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.
Trial design
Treatments tested in this trial
- Dexamethasone
- Dexamethasone
Treatment groups
118 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov