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

RecruitingPhase 4Ages 14 Years - 65 YearsAllInstitute of Hematology & Blood Diseases Hospital…
NCT05888870 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
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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What it tests

  • SCT800 and Daratumumab
  • SCT800
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Where

1 site
Institute of Hematology and Blood Diseases Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College
Tianjin, China
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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