Actively Recruiting

Phase 2
Age: 18Years +
All Genders
NCT05214391

A Prospective, One-arm and Open Clinical Study of Zanubrutinib in the Treatment of Immune Thrombocytopenia

Led by Institute of Hematology & Blood Diseases Hospital, China · Updated on 2025-02-24

30

Participants Needed

1

Research Sites

202 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

To evaluate the safety and efficacy of zanubrutinib in the treatment of immune thrombocytopenia in 30 patients.

CONDITIONS

Official Title

A Prospective, One-arm and Open Clinical Study of Zanubrutinib in the Treatment of Immune Thrombocytopenia

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 18 years or older, male or female
  • Diagnosed with immune thrombocytopenia (ITP) for more than 3 months
  • Primary ITP with platelet count below 30 x 10^9/L before joining
  • Failed to respond or relapsed after corticosteroid therapy and at least one second-line therapy including rituximab over 12 weeks ago and/or thrombopoietin receptor agonists
  • Liver and kidney function tests within 1.5 times the upper limit of normal
  • ECOG physical status score of 2 or less
  • New York Heart Association cardiac function class 2 or less
  • Signed and dated informed consent form
Not Eligible

You will not qualify if you...

  • Uncontrolled serious diseases of major organs such as cancer, liver failure, heart failure, or kidney failure
  • HIV positive
  • Active uncontrollable infections including hepatitis B, hepatitis C, cytomegalovirus, EB virus, or syphilis
  • Severe bleeding like coughing blood, upper gastrointestinal bleeding, or brain hemorrhage
  • Heart diseases, arrhythmias needing treatment, or poorly controlled hypertension
  • History of thrombotic diseases such as pulmonary embolism or atherosclerosis
  • Previous allogeneic stem cell or organ transplant
  • Mental disorders preventing informed consent or trial participation
  • Ongoing toxic symptoms from prior treatments
  • Other serious diseases limiting study participation like diabetes, severe heart failure, unstable angina, or gastric ulcers
  • Septicemia or severe irregular bleeding
  • Current use of antiplatelet drugs
  • Pregnant, breastfeeding, or suspected pregnancy

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Chinese Academy of Medical Science and Blood Disease Hospital

Tianjin, Tianjin Municipality, China, 300020

Actively Recruiting

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Research Team

Y

Yunfei Chen

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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