NCT05888870

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

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 Non-randomized Controlled Trial

• Status: Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: Institute of Hematology & Blood Diseases Hospital, China · Academic / Other
• Sex: All
• Age: 14 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

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

This is a non-randomized controlled trial to compare the outcome of immune tolerance induction therapy usingnon- 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.

Conditions

• Hemophilia A With Inhibitor

Interventions

Type	Name	Description
DRUG	SCT800 and Daratumumab	SCT800 50IU/kg TIW alone or treated with Daratumumab 8mg/kg 4-8 times
DRUG	SCT800	SCT800 50IU/kg TIW alone

Timeline

• Start date: 2023-11-22
• Primary completion: 2026-12-01
• Completion: 2026-12-01
• First posted: 2023-06-05
• Last updated: 2025-02-24

Locations

1 site across 1 country: China