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Taking peoplePhase 2

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

Key facts

Who runs it
Institute of Hematology & Blood Diseases Hospital, China
Where
China2 sites in 1 countryChoose a country to see its sites
Trial code
Status
Recruiting
Phase
Phase 2
People taking part
10 people, planned
Started
25 Jan 2022
Planned end
30 Jun 2025
Type of study
Interventional
Treatments tested
  • zanubrutinib
Record updated
24 February 2025

Who can take part

Age
18 years and older
Sex
Women and men
Healthy volunteers
Cannot take part

The registry criteria, word for word

Show all 20 criteriaShow less

Who can take part

  • Age 18 and above, male or female;
  • Diagnosis of antiphospholipid syndrome;
  • Failure to receive glucocorticoid treatment in the past (the curative effect cannot be maintained, or recurs, or cannot be tolerated); Can not choose other second-line treatment, such as rituximab, cyclosporine, cyclophosphamide, etc.; Or rituximab, cyclosporine and other treatments are ineffective, relapsed or intolerable
  • Plt < 30×10\^9/L;
  • Liver and kidney function, such as ALT, AST, BUN, SCR < 1.5 × upper limit of normal value, passing physical examination
  • ECOG physical state score ≤ 2 points;
  • Cardiac function of the New York Society of Cardiac Function ≤ 2;
  • Signed and dated written informed consent

Who cannot take part

  • Those who have received allogeneic stem cell transplantation or organ transplantation in the past
  • Uncontrollable primary diseases of important organs, such as malignant tumors, liver failure, heart failure, renal failure and other diseases;
  • HIV positive
  • Accompanied by uncontrollable active infection, including hepatitis B, hepatitis C, cytomegalovirus, EB virus and syphilis positive
  • Accompanied by extensive and severe bleeding, such as hemoptysis, upper gastrointestinal hemorrhage, intracranial hemorrhage, etc
  • At present, there are heart diseases, arrhythmias that need treatment or hypertension that researchers judge is poorly controlled
  • Patients with thrombotic diseases such as new pulmonary embolism and unstable period of various arteriovenous thrombosis
  • Patients with mental disorders who cannot normally obtain informed consent and conduct trials and follow-up
  • Other serious diseases that may limit the subject's participation in this test (such as diabetes; Severe cardiac insufficiency; Myocardial obstruction or unstable arrhythmia or unstable angina pectoris in recent 6 months; Gastric ulcer,etc.)
  • Patients with septicemia or other irregular severe bleeding
  • Patients whose toxic symptoms caused by pre-trial treatment have not disappeared
  • Pregnant women, suspected pregnancies (positive pregnancy test for human chorionic gonadotropin in urine at screening) and lactating patients

This trial has no sites in United States.

It has sites in one country. Choose a country to see its sites.

About the trial

What the trial wants to find out

To evaluate the safety and efficacy of zanubrutinib in the treatment of antiphospholipid syndrome with secondary thrombocytopenia in 10 patients.

The group in the trial

  • Intervention ( zanubrutinib)Treatment being tested

    10 enrolled patients are picked up to take zanubrutinib at the indicated dose.

    Treatment: zanubrutinib

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
Prospective, Single Arm and Open Clinical Observation of Zanubrutinib in the Treatment of Antiphospholipid Syndrome With Secondary Thrombocytopenia
Record updated
24 February 2025