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Optimal Dose of Zanubrutinib to Treat Adult Immune Thrombocytopenia

NCT07315373 · Status: NOT_YET_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2026-01-02

No results posted yet for this study

Summary

The goal of this clinical trial is to find the best dose of zanubrutinib when used together with high-dose dexamethasone for adults who are newly diagnosed with primary immune thrombocytopenia (ITP), and to learn how safe and effective this combination treatment is.

Conditions

Interventions

DRUG

Zanubrutinib 80mg/d

Zanubrutinib: 80 mg taken orally once daily for 26 weeks

DRUG

High dose dexamethasone

Dexamethasone: 40 mg taken orally once daily for 4 consecutive days at the beginning of treatment. A second identical 4-day course may be repeated after 2 weeks if an adequate initial platelet response is not achieved.

DRUG

Zanubrutinib 160mg/d

Zanubrutinib: 160 mg taken orally once daily for 26 weeks

DRUG

Zanubrutinib 240mg/d

Zanubrutinib: 240 mg taken orally once daily for 26 weeks

Sponsors & Collaborators

  • Peking University People's Hospital

    lead OTHER

Principal Investigators

  • Xiaohui Zhang · Peking University People's Hospital, Peking University Institute of Hematology, National Clinical Research Center for Hematologic Disease, Beijing Key Laboratory of Hematopoietic Stem Cell Transplantation, Collaborative Innovation Center of Hematology

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-12-25
Primary Completion
2028-12-30
Completion
2029-06-30

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07315373 on ClinicalTrials.gov