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

Sponsor
Institute of Hematology & Blood Diseases Hospital, China
Study ID
NCT05888870
Phase
PHASE4
Status
Recruiting
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Conditions

  • Hemophilia A With Inhibitor

Eligibility Criteria

Sex
ALL
Age
14 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

  • SCT800 and Daratumumab — DRUG
    SCT800 50IU/kg TIW alone or treated with Daratumumab 8mg/kg 4-8 times
  • SCT800 — DRUG
    SCT800 50IU/kg TIW alone

Study Details

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.

Key Dates

Start date
Nov 22, 2023
Status verified
Jan 2025
Primary completion
Dec 1, 2026
Completion
Dec 1, 2026

Study Design

Enrollment
50 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: SCT800 combined with Daratumumab
    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.
  • Active Comparator: SCT800 alone
    ITI using low-dose domestic rFVIII (SCT800) (50IU/kg TIW) alone. Other immunosuppressants could be added after 3 months.

Primary Outcome Measure

success rate of ITI success rate of ITI success rate of ITI success rate of ITI [ Time Frame: 12 months ]

Central Contacts

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