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

Study Overview
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Brief Summary
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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.

Detailed Description
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This is a randomized controlled trial to compare the outcome of immune tolerance induction therapy using SCT800 combined with Daratumumab or SCT800 alone in hemophilia A adolescents and adults with high titer inhibitors. Patients will receive Daratumumab combined with SCT800 or SCT800 alone.

Official Title
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The Outcome Comparison of Immune Tolerance Induction Therapy Using SCT800 Combined With Daratumumab or SCT800 Alone in Hemophilia A Adolescents and Adults With High Titer Inhibitor: a Randomized Controlled Trial

Conditions
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Hemophilia A With Inhibitor

Intervention / Treatment
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* Drug: SCT800 and Daratumumab
* Drug: SCT800


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria Moderate or severe hemophilia A; Aged 14-66 years old; Inhibitor positive at 2 consecutive visits; Inhibitor titer > 10 BU at the screening visit. Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 14 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SCT800 combined with Daratumumab<br>ITI using low-dose domestic rFVIII (SCT800) (50IU/kg TIW) and treated with Daratumumab 8mg/kg 4-8 times. Other immunosuppressants could be added after 3 months. | Drug: SCT800 and Daratumumab<br>* SCT800 50IU/kg TIW alone or treated with Daratumumab 8mg/kg 4-8 times<br>* Other names: Immune tolerance induction combine anti-CD38;|
| Active Comparator: SCT800 alone<br>ITI using low-dose domestic rFVIII (SCT800) (50IU/kg TIW) alone. Other immunosuppressants could be added after 3 months. | Drug: SCT800<br>* SCT800 50IU/kg TIW alone<br>* Other names: Immune tolerance induction only;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| success rate of ITI success rate of ITI success rate of ITI success rate of ITI | Inhibitor titre <0.6 BU⁄mL | 12 months | 
| Success rate and partial success rate of ITI after 3-month treatment | Inhibitor titre <0.6 BU⁄mL | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ITI success time | time to successful tolerance | 12 months |