Actively Recruiting
Safety and Efficacy 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
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to evaluate the safety and effectiveness of zanubrutinib in treating immune thrombocytopenia (ITP), a condition where the immune system causes low platelet counts leading to bleeding issues. ITP treatments currently have limited success, especially for patients who do not respond to standard therapies. Zanubrutinib is a newer drug that targets B cells involved in autoimmune diseases and has shown promise with fewer side effects compared to earlier treatments. In this study, 30 patients will take zanubrutinib starting at 80 mg once daily. If after 4 weeks the treatment is not effective and it is safe, the dose may be increased up to 160 mg twice daily. The treatment period lasts for 24 weeks. If severe side effects occur, the dose may be reduced or the patient may stop the treatment. This trial is designed to provide a new treatment option for adults with ITP who have not responded well to other therapies. Participants will have their platelet counts checked at 12 weeks to assess response and again at 24 weeks to evaluate sustained effects. The study also monitors bleeding severity, adverse events, and immune cell changes during treatment. Physical exams and lab tests will help ensure safety. The total participation time includes treatment and follow-up visits over 24 weeks to assess the drug's impact and safety profile.
CONDITIONS
Brief 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 treatment like rituximab or TPO receptor agonists
- Liver and kidney function tests within 1.5 times upper normal limits
- ECOG physical state score of 2 or less
- New York Heart Association cardiac function class of 2 or less
- Signed informed consent
You will not qualify if you...
- Uncontrolled serious diseases such as cancer, liver failure, heart failure, or kidney failure
- HIV positive
- Active uncontrolled infections including hepatitis B, hepatitis C, cytomegalovirus, EB virus, or syphilis
- Severe bleeding events such as hemoptysis, upper gastrointestinal bleeding, or intracranial hemorrhage
- Current heart diseases, arrhythmias needing treatment, or poorly controlled hypertension
- History of thrombotic diseases like pulmonary embolism or thrombosis
- Previous allogeneic stem cell or organ transplantation
- Mental disorders preventing informed consent or trial participation
- Persistent toxic symptoms from prior treatments
- Other serious diseases limiting participation such as diabetes, severe cardiac insufficiency, unstable arrhythmia, unstable angina, or gastric ulcers
- Septicemia or severe irregular bleeding
- Concurrent use of antiplatelet drugs
- Pregnant, breastfeeding, or suspected pregnancy
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 24 weeks
Participants take zanubrutinib orally with an initial dose of 80mg/day. If ineffective after 4 weeks and safety permits, the dose may be increased to 80mg twice/day or higher, up to a maximum of 160mg twice/day. Treatment lasts for 24 weeks. Dose adjustments or withdrawal may occur due to adverse reactions.
Visits scheduled throughout the 24-week treatment period
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
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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