A Study of Zanubrutinib in Patients With ITP

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-01-01

Study Completion Date

2022-10-30

Brief Summary

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This project was undertaken to evaluate the efficacy and safety of BTK inhibitor Zanubrutinib for the secondary treatment of adults with primary immune thrombocytopenia (ITP).

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Detailed Description

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The investigators are undertaking a prospective trial of 10 adults with ITP in China. Zanubrutinib is administered as 80 mg po. qd for 6 weeks. Platelet count, bleeding and other symptoms were evaluated before and after treatment. Adverse events are also recorded throughout the study.

Conditions

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Immune Thrombocytopenia Bruton Tyrosine Kinase

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Zanubrutinib

Zanubrutinib 80mg po qd 6 weeks

Group Type EXPERIMENTAL

Zanubrutinib

Intervention Type DRUG

Zanubrutinib 80mg po qd 6 weeks

Interventions

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Zanubrutinib

Zanubrutinib 80mg po qd 6 weeks

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Confirmed primary refractory ITP
* Platelet counts \<30×10\^9/L or with bleeding symptoms
* Willing and able to sign written informed consent

Exclusion Criteria

* Secondary thrombocytopenia
* Received chemotherapy or anticoagulants or other drugs affecting the platelet counts within 6 months before the screening visit
* HIV infection or hepatitis B virus or hepatitis C virus infections
* Malignancy
* Severe medical condition (e.g., unstable angina, congestive heart failure, uncontrolled hypertension or cardiac arrhythmia)
* Nursing or pregnant patients
* Patients who are deemed unsuitable for the study by the investigator

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Xiao Hui Zhang

Vice president of Peking University Institute of Hematology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Xiao-Hui Zhang, MD

Role: PRINCIPAL_INVESTIGATOR

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