Hemophilia A
Conditions
Interventions
1:adjust dosing regimens under the
Sponsors
Beijing Children’s Hospital, Capital Medical University
Eligibility
Sex/Gender
Male
Age
1 Years to 18 Years
Inclusion criteria
Inclusion criteria: 1. Patients with severe hemophilia A (F ? : C 50 ED (treatment with F VIII product to calculate the exposure); 4. There was no FVIII inhibitor when enrolled; 5. Regular clinical visits and available visit data; 6. Patients can obtain the informed consent of their legal guardian before enrollment; 7. Prophylaxis was being administered with Kovaltry at the time of enrollment, and baseline data for coyote prophylaxis for at least 6 months prior to phase I could be collected.
Exclusion criteria
Exclusion criteria: 1. Other bleeding disorders; 2. F VIII inhibitor formed: > 0.6 BU (testing confirmed by 2 times, respectively); 3. Failure to comply with the study protocol or refusal to continue to participate in the study; 4. Patients who are currently undergoing progressive ITI treatment or have a history of inhibitor; 5. Plan or have participated in other relevant studies of the leap, or other interventionist studies, or any studies that are expected to affect the study program.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| pharmacokinetic profiles;annual bleeding rate;annual joint bleeding rate;annual spontaneous bleeding rate;life quality scores;joint structure;joint structure·; | — |
Secondary
| Measure | Time frame |
|---|---|
| physical movements;joint function; | — |
Countries
China
Contacts
Public ContactWu Runhui
Beijing Children's Hospital, Capital Medical University
Outcome results
None listed