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NOT YET RECRUITING
NCT05369364
PHASE2

The Combination of Zanubrutinib and High-dose Dexamethasone as First-line Treatment in Adult Immune Thrombocytopenia

Sponsor: Peking University People's Hospital

View on ClinicalTrials.gov

Summary

Randomized, open-label, multicenter study to compare the efficacy and safety of zanubrutinib plus high-dose dexamethasone compared to high-dose dexamethasone monotherapy for the first-line treatment of adults with primary immune thrombocytopenia (ITP).

Official title: The Combination of Oral Zanubrutinib and High-dose Dexamethasone vs High-dose Dexamethasone as First-line Treatment in Adult Immune Thrombocytopenia: A Multicenter, Randomized, Open-label Trial

Key Details

Gender

All

Age Range

18 Years - 70 Years

Study Type

INTERVENTIONAL

Enrollment

150

Start Date

2022-06-01

Completion Date

2026-06-01

Last Updated

2022-05-11

Healthy Volunteers

No

Interventions

DRUG

Zanubrutinib

Zanubrutinib 80mg qd po, 6 consecutive weeks

DRUG

Dexamethasone

Dexamethasone, iv, 40 mg/d, for 4 days (The 4-day course of dexamethasone was repeated in the case of lack of response by day 10)