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

Launched by INSTITUTE OF HEMATOLOGY & BLOOD DISEASES HOSPITAL, CHINA · May 24, 2023

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment approach for adolescents and adults with Hemophilia A who have high levels of inhibitors, which are substances that can make standard treatments less effective. The trial will specifically look at how well a combination of Daratumumab, a type of antibody, and SCT800 (a modified form of a clotting factor) works in helping patients stop bleeding and maintain a stable condition over time. Participants will be monitored to see how quickly they respond to the treatment, how long they can stay in remission, and if they experience any relapses.

To be eligible for this study, participants need to be between 14 and 66 years old, have moderate to severe Hemophilia A, and have tested positive for inhibitors during two visits. They should also have a high inhibitor level at the start of the trial. However, some individuals may not be able to participate if they have specific allergies, other immune diseases, or if they have not responded to previous treatments. Those who join the trial can expect regular check-ups and support as they undergo this new treatment option. This research is important because it aims to improve the lives of those living with a challenging condition like Hemophilia A.

Gender

ALL

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.