To evaluate the time of response, sustained remission rate, and relapse rate of CD38 monoclonal antibody (Daratumumab) combined with SCT800 (rFVIII) in the treatment of hemophilia A adolescents and adults with high titer inhibitors.
This is a non-randomized controlled trial to compare the outcome of immune tolerance induction therapy usingnon- SCT800 combined with Daratumumab or SCT800 alone in hemophilia A adolescents and adults with high titer inhibitors. Patients will receive Daratumumab combined with SCT800 or SCT800 alone.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
50
SCT800 50IU/kg TIW alone or treated with Daratumumab 8mg/kg 4-8 times
SCT800 50IU/kg TIW alone
Institute of Hematology and Blood Diseases Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College
Tianjin, China
RECRUITINGsuccess rate of ITI success rate of ITI success rate of ITI success rate of ITI
Inhibitor titre \<0.6 BU⁄mL
Time frame: 12 months
Success rate and partial success rate of ITI after 3-month treatment
Inhibitor titre \<0.6 BU⁄mL
Time frame: 3 months
ITI success time
time to successful tolerance
Time frame: 12 months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.