RecruitingPhase 3NCT07559331

High-Dose Dexamethasone Combined With Orelabrutinib Versus High-Dose Dexamethasone Combined With Placebo in Adult Patients With Newly Diagnosed Primary Immune Thrombocytopenia

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

Sponsor

Shandong University

Enrollment

86 participants

Start Date

Apr 8, 2026

Study Type

INTERVENTIONAL

Conditions

Primary Immune Thrombocytopenia (ITP)

Summary

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.

Eligibility

Min Age: 18 YearsMax Age: 80 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called High-Dose Dexamethasone Combined with Orelabrutinib and a drug called High-Dose Dexamethasone Combined with Placebo for people with primary immune thrombocytopenia (itp). The study is currently recruiting participants at 1 location. People eligible for this study include aged 18 Years to 80 Years.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGHigh-Dose Dexamethasone Combined with Orelabrutinib

Orelabrutinib 50 mg once daily (QD) (for 3 consecutive months) combined with Dexamethasone 40 mg/day for 4 days

DRUGHigh-Dose Dexamethasone Combined with Placebo

Placebo 50 mg once daily (QD) (for 3 consecutive months) combined with Dexamethasone 40 mg/day for 4 days

Locations(1)

Qilu Hospital of Shandong University

Jinan, Shandong, China

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NCT07559331

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