Hemophilia B
Conditions
Interventions
Dose-extension group:ZS801 injection
Low-dose group:ZS801 injection
Middle-dose group:ZS801 injection
High-dose group:ZS801 injection
Sponsors
Institute of Hematology & Blood Diseases Hospital
Eligibility
Sex/Gender
Male
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Males=18 years old at the time of signing the informed consent; 2. Clinical diagnosis of hemophilia B, endogenous F? activity level =2% during the screening period or past history; 3. =3 bleeding events in the past 1 year and/or chronic hemophilic arthropathy with one or more joints requires treatment with an F? product. 4. A history of exposure (ED) of =100 days to any recombinant and/or plasma-derived F? product; 5. The subjects are willing to participate and fully informed, fully understand the study, comply with the requirements of the study protocol, and are willing to complete the study as planned, and voluntarily provide biological samples for testing according to the requirements of the protocol.
Exclusion criteria
Exclusion criteria: 1. Hypersensitivity to any component of the study drug or a condition that can not use; 2. Those who cannot tolerate immunosuppressive drugs or steroid treatment; 3. Have a history of malignant tumors or currently have any malignant tumors; 4. Severe heart disease, including angina pectoris, myocardial infarction, heart failure, clinically significant congenital heart disease, heart valve disease, arrhythmia, etc.; 5. A history of potentially serious liver disease or liver disease; 6. Diabetic subjects with poor control after drug treatment; 7. Acute/chronic infectious diseases or other chronic diseases that the investigator judged would increase the risk of participating in the trial; 8. Epilepsy, history of mental illness (such as schizophrenia, depression, mania or anxiety, etc.), obvious mental disorder, or other causes of incapacity or cognitive disability; 9. Investigators believe that subjects have poor compliance or are expected to be less likely to complete follow-up; 10. There are clinically significant diseases or other reasons that the researcher and/or collaborators consider unsuitable to participate in this researcher.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Adverse event;Vital signs;Physical examination;Laboratory examination;AAV neutralizing antibody; | — |
Secondary
| Measure | Time frame |
|---|---|
| FIX:C;Annualized bleeding rate;Vector shedding; | — |
Countries
CHINA
Contacts
Public ContactLei Zhang
Institute of Hematology & Blood Diseases Hospital
Outcome results
None listed