RecruitingPhase 4NCT05888870

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

Sponsor

Institute of Hematology & Blood Diseases Hospital, China

Enrollment

50 participants

Start Date

Nov 22, 2023

Study Type

INTERVENTIONAL

Conditions

Hemophilia A With Inhibitor

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.

Eligibility

Min Age: 14 YearsMax Age: 65 Years

Inclusion Criteria4

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 Criteria5

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.

Interventions

DRUGSCT800 and Daratumumab

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

DRUGSCT800

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

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT05888870