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Optimal Dose of Zanubrutinib to Treat Adult Immune Thrombocytopenia | Clinical Trials | Clareo Health

NOT_YET_RECRUITINGPHASE1

Optimal Dose of Zanubrutinib to Treat Adult Immune Thrombocytopenia

The FIND Study: A Dose-finding Study to Identify the Optimal Dose of Zanubrutinib in Adults With Immune Thrombocytopenia

NCT07315373•Peking University People's Hospital

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - 70 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Confirmed newly-diagnosed, treatment-naive ITP;
•2. Platelet counts \<30×10\^9/L ;
•3. Platelet counts \< 50×10\^9/L and significant bleeding symptoms (WHO bleeding scale 2 or above);
•4. Willing and able to sign written informed consent.

Exclusion Criteria

•1. Received chemotherapy or anticoagulants or other drugs affecting the platelet counts within 6 months before the screening visit;
•2. Received first-line and second-line ITP-specific treatments (eg, steriods, cyclophosphamide, 6-mercaptopurine, vincristine, vinblastine, etc) ;
•3. Current HIV infection or hepatitis B virus or hepatitis C virus infections;
•4. Active infection;
•5. Maligancy;
•6. Severe medical condition (lung, hepatic or renal disorder) other than ITP. Unstable or uncontrolled disease or condition related to or impacting cardiac function (e.g., unstable angina, congestive heart failure, uncontrolled hypertension or cardiac arrhythmia);
•7. Female patients who are nursing or pregnant, who may be pregnant, or who contemplate pregnancy during the study period; a history of clinically significant adverse reactions to previous corticosteroid therapy
•8. Have a known diagnosis of other autoimmune diseases, established in the medical history and laboratory findings with positive results for the determination of antinuclear antibodies, anti-cardiolipin antibodies, lupus anticoagulant or direct Coombs test;
•9. Patients who are deemed unsuitable for the study by the investigator.

Key Dates

Start Date

December 25, 2025

Primary Completion Date

December 30, 2028

Completion Date

June 30, 2029

Last Updated

January 2, 2026

Enrollment

ESTIMATED participants

Conditions

Immune Thrombocytopenia

Interventions

Zanubrutinib 80mg/d

DRUG

High dose dexamethasone

DRUG

Zanubrutinib 160mg/d

DRUG

Zanubrutinib 240mg/d

DRUG

Contacts

Xiaohui Zhang, MD

CONTACT

8688324577 zhangxh100@sina.com

Qiusha Huang, MD

CONTACT

8688324577 huangfuqs@163.com

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Immune Thrombocytopenia

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RECRUITINGPHASE2

Anti-CD38 Monoclonal Antibody Combined With Rituximab in the Management of Primary Immune Thrombocytopenia (ITP)

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 2, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Optimal Dose of Zanubrutinib to Treat Adult Immune Thrombocytopenia

Inclusion Criteria

Exclusion Criteria

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