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Completed

NCT Number: NCT05279872

A Study of Zanubrutinib in Patients With ITP

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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Key information

Conditions

Immune Thrombocytopenia Autoimmune Diseases Blood Coagulation Disorders Blood Platelet Disorders Bruton Tyrosine Kinase Cytopenia Hematologic Diseases Hemic and Lymphatic Diseases Hemorrhage Hemorrhagic Disorders Immune System Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Purpura Purpura, Thrombocytopenic Purpura, Thrombocytopenic, Idiopathic Signs and Symptoms Skin Manifestations Thrombocytopenia Thrombotic Microangiopathies

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Peking University Insititute of Hematology, Peking University People's Hospital

Beijing, Beijing Municipality, 100010, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Zanubrutinib

Drug

Zanubrutinib 80mg po qd 6 weeks

Primary outcomes

  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 outcomes

  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 .

Sponsors and collaborators

Lead sponsor

Peking University People's Hospital

Other

Registry information

Official study title

A Study of Zanubrutinib in Patients With Primary Immune Thrombocytopenia (ITP)

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Mar 15, 2022
Registry last updated
Oct 10, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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