Actively Recruiting
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
Eligibility Criteria
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
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
Trial Site Locations
Total: 1 location
1
Chinese Academy of Medical Science and Blood Disease Hospital
Tianjin, Tianjin Municipality, China, 300020
Actively Recruiting
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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