Overview
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.
Description
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.
Eligibility
Inclusion Criteria
- Moderate or severe hemophilia A;
- Aged 14-66 years old;
- Inhibitor positive at 2 consecutive visits;
- Inhibitor titer > 10 BU at the screening visit.
Exclusion Criteria:
- The patient has contraindications to drug ingredients or hamster protein allergy;
- Suffering from other immune diseases or Using immunosuppressant IS to treat another disease(s);
- Failed systemic ITI treatment in history;
- Poor patients compliance;
- The investigator believes that there are any other reasons that make the patient unsuitable to participate in this study.