ITI Using SCT800 Alone or Combining Daratumumab in Hemophilia A Adolescents and Adults With High Titer Inhibitor

The Outcome Comparison of Immune Tolerance Induction Therapy Using SCT800 Combined With Daratumumab or SCT800 Alone in Hemophilia A Adolescents and Adults With High Titer Inhibitor: a Non-randomized Controlled Trial

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.

Inclusion Criteria

1. Moderate or severe hemophilia A;
2. Aged 14-66 years old;
3. Inhibitor positive at 2 consecutive visits;
4. Inhibitor titer > 10 BU at the screening visit.

Exclusion Criteria:

1. The patient has contraindications to drug ingredients or hamster protein allergy;
2. Suffering from other immune diseases or Using immunosuppressant IS to treat another disease(s);
3. Failed systemic ITI treatment in history;
4. Poor patients compliance;
5. The investigator believes that there are any other reasons that make the patient unsuitable to participate in this study.