drugset / Trial / NCT05888870
ITI Using SCT800 Alone or Combining Daratumumab in Hemophilia A Adolescents and Adults With High Titer Inhibitor
Phase 4
Recruiting
50 enrolled
Institute of Hematology & Blood Diseases Hospital, China
Sinocelltech Ltd. · collab
Non-randomizedParallel-groupOpen-labelTreatment
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.
Timeline
- Start
- 2023-11-22
- Primary completion
- 2026-12-01
- Completion
- 2026-12-01
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Daratumumab | Monoclonal antibody | 8 mg/kg | — |
| Comparator | SCT800 | Protein / enzyme biologic | 50 iu/kg | — |