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

NCT ID: NCT05888870

Last Updated: 2025-02-24

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE4
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-11-22
• Study Completion Date: 2026-12-01

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.

Conditions

Hemophilia A With Inhibitor

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

SCT800 combined with 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.

Group Type: EXPERIMENTAL

SCT800 and Daratumumab

Intervention Type: DRUG

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

SCT800 alone

ITI using low-dose domestic rFVIII (SCT800) (50IU/kg TIW) alone. Other immunosuppressants could be added after 3 months.

Group Type: ACTIVE_COMPARATOR

SCT800

Intervention Type: DRUG

SCT800 50IU/kg TIW alone

Interventions

SCT800 and Daratumumab

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

Intervention Type: DRUG

SCT800

SCT800 50IU/kg TIW alone

Intervention Type: DRUG

Other Intervention Names

Immune tolerance induction combine anti-CD38; Immune tolerance induction only

Eligibility Criteria

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.

• Minimum Eligible Age: 14 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sinocelltech Ltd.

INDUSTRY

Sponsor Role: collaborator

Institute of Hematology & Blood Diseases Hospital, China

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Lei Zhang

Role: PRINCIPAL_INVESTIGATOR

Chinese Academy of Medical Science and Blood Disease Hospital

Renchi Yang

Role: PRINCIPAL_INVESTIGATOR

Chinese Academy of Medical Science and Blood Disease Hospital

Locations

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

Tianjin, , China

Site Status: RECRUITING

Countries

China

Central Contacts

Wei Liu

Role: CONTACT

liuwei1@ihcams.ac.cn

+8613820261971

Lei Zhang

Role: CONTACT

zhanglei1@ihcams.ac.cn

Facility Contacts

Shuo Chen

Role: primary

chenshuo@ihcams.ac.cn

L Liu

Role: backup

gcp@ihcams.ac.cn

Other Identifiers

IIT2022035

Identifier Type: -

Identifier Source: org_study_id