Actively Recruiting
ITI Using SCT800 Alone or Combining Daratumumab in Hemophilia A Adolescents and Adults With High Titer Inhibitor
Led by Institute of Hematology & Blood Diseases Hospital, China · Updated on 2025-02-24
50
Participants Needed
1
Research Sites
157 weeks
Total Duration
On this page
Sponsors
I
Institute of Hematology & Blood Diseases Hospital, China
Lead Sponsor
S
Sinocelltech Ltd.
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
ITI Using SCT800 Alone or Combining Daratumumab in Hemophilia A Adolescents and Adults With High Titer Inhibitor
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Moderate or severe hemophilia A
- Aged 14 to 66 years old
- Positive for inhibitors at two consecutive visits
- Inhibitor titer greater than 10 Bethesda Units at screening visit
You will not qualify if you...
- Allergy or contraindications to study drugs or hamster protein
- Having other immune diseases or using immunosuppressants for other conditions
- Previous failure of systemic immune tolerance induction treatment
- Poor compliance with treatment requirements
- Any other reason deemed by the investigator to make participation unsuitable
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Institute of Hematology and Blood Diseases Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College
Tianjin, China
Actively Recruiting
Research Team
W
Wei Liu
CONTACT
L
Lei Zhang
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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