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RECRUITING
NCT05888870
PHASE4

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

View on ClinicalTrials.gov

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.

Official title: 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

Key Details

Gender

All

Age Range

14 Years - 65 Years

Study Type

INTERVENTIONAL

Enrollment

50

Start Date

2023-11-22

Completion Date

2026-12-01

Last Updated

2025-02-24

Healthy Volunteers

No

Interventions

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

Locations (1)

Institute of Hematology and Blood Diseases Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College

Tianjin, China