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Recruiting Phase 4 NCT05888870

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

Trial Parameters

Condition Hemophilia A With Inhibitor
Sponsor Institute of Hematology & Blood Diseases Hospital, China
Study Type INTERVENTIONAL
Phase Phase 4
Enrollment 50
Sex ALL
Min Age 14 Years
Max Age 65 Years
Start Date 2023-11-22
Completion 2026-12-01
Interventions
SCT800 and DaratumumabSCT800

Brief Summary

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.

Eligibility Criteria

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.

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