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

Hemophilia A With Inhibitor Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05888870
• Other study ID #: SCT800-AITI
• Status: Recruiting
• Phase: Phase 4
• Start date: November 22, 2023
• Est. completion date: December 1, 2026

Study information

• Verified date: January 2024
• Source: Institute of Hematology & Blood Diseases Hospital, China
• Contact: Wei Liu
• Phone: +8613820261971
• Email: liuwei1[@]ihcams.ac.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: December 1, 2026
• Est. primary completion date: December 1, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 14 Years to 65 Years

Eligibility

Inclusion Criteria

1. Moderate or severe hemophilia A;

2. Aged 14-66 years old;

3. Inhibitor positive at 2 consecutive visits;

4. Inhibitor titer > 10 BU at the screening visit.

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.

Related Conditions & MeSH terms

• Hemophilia A
• Hemophilia A With Inhibitor

Intervention

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

Locations

Country	Name	City	State
China	Institute of Hematology and Blood Diseases Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College	Tianjin

Sponsors (2)

Lead Sponsor	Collaborator
Institute of Hematology & Blood Diseases Hospital, China	Sinocelltech Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	success rate of ITI success rate of ITI success rate of ITI success rate of ITI	Inhibitor titre <0.6 BU/mL	12 months
Primary	Success rate and partial success rate of ITI after 3-month treatment	Inhibitor titre <0.6 BU/mL	3 months
Secondary	ITI success time	time to successful tolerance	12 months