Actively Recruiting
High-Dose Dexamethasone Combined With Orelabrutinib Versus High-Dose Dexamethasone Combined With Placebo in Adult Patients With Newly Diagnosed Primary Immune Thrombocytopenia
Led by Shandong University · Updated on 2026-04-30
86
Participants Needed
1
Research Sites
90 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating a treatment for adults newly diagnosed with Primary Immune Thrombocytopenia (ITP), a condition affecting platelet counts. This Phase 3 randomized controlled trial compares high-dose Dexamethasone combined with Orelabrutinib against high-dose Dexamethasone combined with a placebo to understand their effects on this condition. The study is led by Shandong University and aims to measure the overall response rate over an average of 6 months. Participants will receive either Orelabrutinib 50 mg once daily for 3 months combined with Dexamethasone 40 mg/day for 4 days, or a matching placebo once daily for 3 months combined with the same Dexamethasone regimen. The trial includes two groups: one receiving the active combination and one receiving placebo with Dexamethasone. Treatment is given under close monitoring in a double-blind, randomized approach. During the study, participants will be monitored for their platelet response and bleeding status, with regular blood tests to track platelet counts and other safety measures. The main outcome is the overall response rate throughout approximately 6 months, with additional assessments at 1, 2, and 3 months. Participants will be followed closely for safety and treatment response throughout this period.
CONDITIONS
Brief Title
High-Dose Dexamethasone Combined With Orelabrutinib Versus High-Dose Dexamethasone Combined With Placebo in Adult Patients With Newly Diagnosed Primary Immune Thrombocytopenia
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Understand the nature, risks, and benefits of the trial and voluntarily sign informed consent
- Male or female aged 18 to 80 years inclusive
- Body weight of 35 kg or more at screening
- Newly diagnosed, untreated primary ITP with platelet count less than 30x10⁹/L and no active bleeding in vital organs
- Responded to prior oral dexamethasone 40 mg/day for 4 days with platelet count ≥30x10⁹/L, at least 2-fold increase from baseline, and no active bleeding between Day 5 and 7 post-treatment
- Women of childbearing potential must use effective contraception during screening, the trial, and for 90 days after last dose
You will not qualify if you...
- Severe ITP at screening requiring urgent rescue treatment within 2 weeks after enrollment
- Autoimmune systemic diseases other than ITP that affect study outcomes
- Failed to respond to prior oral dexamethasone 40 mg/day for 4 days as defined by platelet count or bleeding criteria
- History of intracranial hemorrhage within 6 months prior to screening
- History of coagulation disorders other than ITP
- Known hypersensitivity to study drug components
- Known HIV infection or positive serologic tests
- Positive tuberculosis screening or active/incomplete tuberculosis treatment
- Activated partial thromboplastin time (aPTT) or INR ≥1.5 times upper limit of normal
- Organ dysfunction based on lab tests including low neutrophils, hemoglobin, lymphocytes, abnormal liver enzymes, amylase, lipase, low eGFR, or low immunoglobulin G
- Pregnant or lactating women
- Unable to undergo blood collection or with contraindications to phlebotomy
- Any other condition deemed unsuitable by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 3 months
Participants receive high-dose dexamethasone for 4 days combined with either Orelabrutinib or placebo taken once daily for 3 consecutive months.
Weekly visits for up to 12 weeks
Trial Site Locations
Total: 1 location
1
Qilu Hospital of Shandong University
Jinan, Shandong, China
Actively Recruiting
Research Team
M
Min Hou, Professor
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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