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
142 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This is a randomized controlled study of high-dose Dexamethasone combined with Orelabrutinib versus high-dose Dexamethasone combined with placebo in adult patients with newly diagnosed Primary Immune Thrombocytopenia.
CONDITIONS
Official 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 and voluntarily agree to the study procedures by signing informed consent
- Male or female aged 18 to 80 years inclusive
- Body weight of at least 35 kg at screening
- Newly diagnosed, untreated primary ITP with platelet count below 30 x 10^9/L and no active bleeding in vital organs
- Responded to prior treatment with oral dexamethasone 40 mg/day for 4 days, showing platelet count increase and no bleeding between Day 5 and Day 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 needing urgent or rescue treatment within 2 weeks
- Autoimmune systemic diseases other than ITP affecting study outcomes
- Failed to respond to prior dexamethasone treatment as defined by low platelet counts or active bleeding between Day 5 and Day 7 post-treatment
- History of intracranial hemorrhage within 6 months prior to screening
- History of coagulation disorders other than ITP
- Known allergy to study drug components
- Known HIV infection or positive HIV test
- Positive tuberculosis screening or active/latent tuberculosis
- Abnormal clotting tests above 1.5 times upper limit of normal
- Organ dysfunction indicated by abnormal blood counts or liver, kidney, pancreas tests
- Pregnant or lactating women
- Unable to undergo blood collection or contraindication 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
Trial Site Locations
Total: 1 location
1
Qilu Hospital of Shandong University
Jinan, Shandong, China
Actively Recruiting
Research Team
M
Min Hou, Professor
CONTACT
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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