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

Phase 4

Recruiting

• Conditions: Hemophilia A With Inhibitor
• Interventions: Drug: SCT800 and Daratumumab; Drug: SCT800

• Registration Number: NCT05888870
• Lead Sponsor: Institute of Hematology & Blood Diseases Hospital, China

Brief 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.

Study Timeline

• Study First Submitted: 2023-05-24
• Study First Submitted QC: 2023-05-24
• Study First Posted: 2023-06-05
• Study Start: 2023-11-22
• Status Verified: 2025-01
• Last Update Submitted: 2025-02-20
• Last Update Posted: 2025-02-24
• Primary Completion: 2026-12-01
• Study Completion: 2026-12-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

Not provided

Exclusion Criteria

1. The patient has contraindications to drug ingredients or hamster protein allergy;
2. Suffering from other immune diseases or Using immunosuppressant IS to treat another disease(s);
3. Failed systemic ITI treatment in history;
4. Poor patients compliance;
5. The investigator believes that there are any other reasons that make the patient unsuitable to participate in this study.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
SCT800 combined with Daratumumab	SCT800 and 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.
SCT800 alone	SCT800	ITI using low-dose domestic rFVIII (SCT800) (50IU/kg TIW) alone. Other immunosuppressants could be added after 3 months.

Primary Outcome Measures

Name	Time	Method
success rate of ITI success rate of ITI success rate of ITI success rate of ITI	12 months	Inhibitor titre \<0.6 BU⁄mL
Success rate and partial success rate of ITI after 3-month treatment	3 months	Inhibitor titre \<0.6 BU⁄mL

Secondary Outcome Measures

Name	Time	Method
ITI success time	12 months	time to successful tolerance

Trial Locations

Locations (1)

Institute of Hematology and Blood Diseases Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College; 🇨🇳 Tianjin, China