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RECRUITING
NCT07559331
PHASE3

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

View on ClinicalTrials.gov

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.

Official title: 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

Key Details

Gender

All

Age Range

18 Years - 80 Years

Study Type

INTERVENTIONAL

Enrollment

86

Start Date

2026-04-08

Completion Date

2028-12-31

Last Updated

2026-04-30

Healthy Volunteers

No

Interventions

DRUG

High-Dose Dexamethasone Combined with Orelabrutinib

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

DRUG

High-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