Actively Recruiting

Phase 2
Age: 18Years +
All Genders
NCT05199909

Safety and Efficacy of Zanubrutinib in the Treatment of Antiphospholipid Syndrome With Secondary Thrombocytopenia

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

10

Participants Needed

2

Research Sites

178 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 antiphospholipid syndrome with secondary thrombocytopenia in 10 patients.

CONDITIONS

Official Title

Safety and Efficacy of Zanubrutinib in the Treatment of Antiphospholipid Syndrome With Secondary Thrombocytopenia

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 18 and above, male or female
  • Diagnosis of antiphospholipid syndrome
  • Previous glucocorticoid treatment failed, relapsed, or was not tolerated
  • Unable to choose or failed other second-line treatments like rituximab or cyclosporine
  • Platelet count less than 30 × 10^9/L
  • Liver and kidney function tests within 1.5 times the upper normal limit
  • ECOG physical state score of 2 points or less
  • New York Heart Association cardiac function classification of 2 or less
  • Signed written informed consent
Not Eligible

You will not qualify if you...

  • Uncontrollable serious diseases such as malignant tumors, liver failure, heart failure, or kidney failure
  • HIV positive
  • Active uncontrolled infections including hepatitis B, hepatitis C, cytomegalovirus, EB virus, or syphilis
  • Severe bleeding such as hemoptysis, upper gastrointestinal bleeding, or intracranial hemorrhage
  • Heart diseases, arrhythmias requiring treatment, or poorly controlled hypertension
  • Recent thrombotic diseases like new pulmonary embolism or unstable thrombosis
  • History of allogeneic stem cell or organ transplantation
  • Mental disorders preventing informed consent or trial participation
  • Persistent toxic symptoms from previous treatments
  • Other serious diseases limiting participation such as diabetes or severe cardiac insufficiency
  • Septicemia or other severe irregular bleeding
  • Pregnant, suspected pregnancy, or breastfeeding

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 2 locations

1

Chinese Academy of Medical Science and Blood Disease Hospital

Tianjin, Tianjin Municipality, China, 300020

Actively Recruiting

2

Institute of Hematology & Blood Diseases Hospital

Tianjin, Tianjin Municipality, China, 300020

Actively Recruiting

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Research Team

Y

Yunfei Chen, MD

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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