Status:
COMPLETED
Zanubrutinib for HLH
Lead Sponsor:
Beijing Friendship Hospital
Conditions:
HLH
Eligibility:
All Genders
14+ years
Phase:
PHASE3
Brief Summary
This study is a prospective single-arm clinical study, focusing on Hemophagocytic lymphohistocytosis，to evaluate the clinical efficacy and safety of zanubrutinib.
Eligibility Criteria
Inclusion
- Unlimited gender, age ≥ 14 years old;
- HLH was diagnosed according to HLH-04 diagnostic criteria;
- Before the study, there was no severe liver function injury; Serum creatinine ≤ 1.5 times the upper limit of normal value;
- Sign informed consent
Exclusion
- Allergic to zebutinib;
- Currently active important cardiovascular diseases with clinical significance; The functions of important organs such as heart and lung unrelated to HLH were seriously abnormal;
- Known human immunodeficiency virus (HIV) or active hepatitis B (HBV) or hepatitis C (HCV) infection;
- Pregnant or lactating women and patients of childbearing age who refuse to take appropriate contraceptive measures during this trial;
- Serious mental illness;
- Active massive hemorrhage of internal organs;
- Uncontrollable infection;
- At the same time, participate in other clinical researchers
Key Trial Info
Start Date :
February 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2023
Estimated Enrollment :
16 Patients enrolled
Trial Details
Trial ID
NCT05320575
Start Date
February 1 2022
End Date
August 1 2023
Last Update
April 11 2024
Active Locations (1)
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1
Beijing Friendship Hospital, Capital Medical University
Beijing, China