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

Recruiting now · Phase 4

Conditions studied: Hemophilia A With Inhibitor

In brief

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.

Key facts

Study ID

NCT05888870

Run by

Institute of Hematology & Blood Diseases Hospital, China

People needed

50

Starts

2023-11-22

Expected to finish

2026-12-01

Last updated by the study team

2025-02-24

Who can join

Age: 14 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

• 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.

Where it is running

• Institute of Hematology and Blood Diseases Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College — Tianjin, China (enrolling)

Full record on ClinicalTrials.gov

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