Actively Recruiting
Outcome Comparison of SCT800 Combined With Daratumumab or SCT800 Alone in Hemophilia A Adolescents and Adults With High Titer Inhibitor: a Non-randomized Controlled Trial
Led by Institute of Hematology & Blood Diseases Hospital, China · Updated on 2025-02-24
50
Participants Needed
1
Research Sites
N/A
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
Researchers are evaluating immune tolerance induction (ITI) therapies for adolescents and adults aged 14 to 65 with moderate or severe hemophilia A who have high titer inhibitors. This non-randomized controlled trial compares the response time, sustained remission, and relapse rates between two treatments: SCT800 alone and SCT800 combined with the CD38 monoclonal antibody Daratumumab. The study aims to better understand how these treatments work for patients with inhibitor-positive hemophilia A. Participants will receive one of two treatment regimens: low-dose domestic recombinant factor VIII (SCT800) at 50 IU/kg three times a week alone, or SCT800 combined with Daratumumab at 8 mg/kg administered 4 to 8 times. After three months, other immunosuppressants may be added if needed. This design allows comparison of outcomes between combination therapy and SCT800 alone. Throughout the study, researchers will monitor the success rate of ITI at 3 months and 12 months, including partial success and time to success. Patients will be assessed regularly for inhibitor levels and response to treatment. The study includes detailed follow-up to evaluate remission and relapse rates over time. Participation will last at least 12 months, with ongoing evaluation of treatment effects and safety.
CONDITIONS
Brief 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 14-66 years old
- Positive inhibitor at 2 consecutive visits
- Inhibitor titer greater than 10 BU at screening visit
You will not qualify if you...
- Allergy to drug ingredients or hamster protein
- Other immune diseases or using immunosuppressants for other diseases
- Previous failure of systemic ITI treatment
- Poor compliance
- Any other reasons deemed unsuitable by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Up to 12 months
Participants receive immune tolerance induction therapy using SCT800 alone or combined with Daratumumab, with dosing three times a week for SCT800 and Daratumumab administered 4 to 8 times. Other immunosuppressants may be added after 3 months.
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
L
Lei Zhang
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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