Hemophilia A
Conditions
Interventions
Single arm:A single-dose intravenous infusion of BBM002 injection
Sponsors
The First Affiliated Hospital of Nanyang Medical College
Eligibility
Sex/Gender
Male
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Subjects voluntarily sign informed consent; 2. Be male and >= 18 years of age; 3. Be clinically diagnosed as moderate or severe hemophilia A, that is, the endogenous FVIII activity level is 2% when screening due to insufficient elution of FVIII protein products, the activity can be retested after sufficient elution; 4. Have had >= 150 prior exposure days (EDs) to any FVIII protein products; 5. The pre-existing antibody titer does not exceed the specified value; 6. Have had bleeding events and/or infusions with FVIII protein products during the last 12 weeks documented in the subjects' medical records; 7. Have no prior history of hypersensitivity or anaphylaxis associated with any FVIII or IV immunoglobulin administration; 8. Have no FVIII inhibitor; 9. Agree to use a reliable barrier contraception method; 10. Compliance is good and patients can complete the subject's diary through regular follow-up.
Exclusion criteria
Exclusion criteria: 1. Viral serological test: Have active hepatitis B or C, and HBsAg, hepatitis B core antibody, hepatitis B virus-DNA positivity or hepatitis C virus-RNA viral load positivity, respectively; HIV positive patients, patients seropositive for syphilis and patients with tuberculosis infection; 2. Currently on antiviral therapy for hepatitis B or C; 3. Patients with coagulation disorders and thrombophilia, in addition to hemophilia A; 4. Use of any other systematic immunosuppressant other than glucocorticoids; 5. Subjects with vaccination history prior to screening, or having vaccination schedule after study medication; 6. Subjects with major diseases that are judged by the investigator to be unsuitable to participate in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The incidence of treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs); | — |
Countries
China
Contacts
Public ContactHuibing Dang
Outcome results
None listed