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A Study of Zanubrutinib in Patients With ITP

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05279872
Recruitment Status : Recruiting
First Posted : March 15, 2022
Last Update Posted : March 15, 2022
Sponsor:
Information provided by (Responsible Party):
Xiao Hui Zhang, Peking University People's Hospital

Study Description
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Brief Summary:
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).

Condition or disease Intervention/treatment Phase
Immune Thrombocytopenia Bruton Tyrosine Kinase Drug: Zanubrutinib Phase 1 Phase 2

Detailed Description:
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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Study of Zanubrutinib in Patients With Primary Immune Thrombocytopenia (ITP)
Actual Study Start Date : January 1, 2022
Estimated Primary Completion Date : July 1, 2022
Estimated Study Completion Date : September 1, 2022

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Zanubrutinib
Zanubrutinib 80mg po qd 6 weeks
 Drug: Zanubrutinib
Zanubrutinib 80mg po qd 6 weeks


Outcome Measures
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Primary Outcome Measures :
  1. Overall response (OR) [ Time Frame: 6 weeks ]
    The maintenance of platelet count ≥ 30 x 10^9/L, at least 2-fold increase of the baseline count, the absence of bleeding, and no need for rescue medication at the 6-week follow-up.


Secondary Outcome Measures :
  1. Complete response (CR) [ Time Frame: 6 weeks ]
    Complete response (CR) was defined as platelet count more than 100,000 per cubic millimeter and absence of bleeding.

  2. Time to response [ Time Frame: 6 weeks ]
    The time from starting treatment to time of achievement of Response.

  3. Bleeding events [ Time Frame: 6 weeks ]
    The WHO Bleeding Scale is a measure of bleeding severity with the following grades: grade 0 = no bleeding, grade 1= petechiae, grade 2= mild blood loss, grade 3 = gross blood loss, and grade 4 = debilitating blood loss.

  4. Side Effects [ Time Frame: 6 weeks ]
    Potential side effects include leukopenia, nausea and diarrhea, infectious diseases, etc .


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05279872


Contacts
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Contact: Xiao-Hui Zhang, MD 15010638916 1710301242@pku.edu.cn
Contact: Zhuo-Yu An, MD 15010638916 anzhuoyu@pku.edu.cn

Locations
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China, Beijing
Peking University Insititute of Hematology, Peking University People's Hospital Recruiting
Beijing, Beijing, China, 100010
Contact: Xiao Hui Zhang, doctor       zhangxh100@sina.com   
Contact: Zhuo Yu An, doctor    +8615010638916    anzhuoyu@pku.edu.cn   
Sponsors and Collaborators
Peking University People's Hospital
Investigators
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Principal Investigator: Xiao-Hui Zhang, MD 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
More Information
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Responsible Party: Xiao Hui Zhang, Vice president of Peking University Institute of Hematology, Peking University People's Hospital
ClinicalTrials.gov Identifier: NCT05279872    
Other Study ID Numbers: PKU-ITP032
First Posted: March 15, 2022    Key Record Dates
Last Update Posted: March 15, 2022
Last Verified: March 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Thrombocytopenia
Purpura, Thrombocytopenic, Idiopathic
Blood Platelet Disorders
Hematologic Diseases
Purpura, Thrombocytopenic
Purpura
Blood Coagulation Disorders
Thrombotic Microangiopathies
Hemorrhagic Disorders
Autoimmune Diseases
 Immune System Diseases
Hemorrhage
Pathologic Processes
Skin Manifestations
Zanubrutinib
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action