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

NCT05888870 | Recruiting Phase 4 DMC

• 1 other identifier: IIT2022035
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Hemophilia A With Inhibitor

Outcome Measures

Primary Outcomes (2)

• success rate of ITI success rate of ITI success rate of ITI success rate of ITI

  Inhibitor titre \<0.6 BU⁄mL

  12 months

• Success rate and partial success rate of ITI after 3-month treatment

  Inhibitor titre \<0.6 BU⁄mL

  3 months

Secondary Outcomes (1)

• ITI success time

  12 months

Study Arms (2)

SCT800 combined with Daratumumab

EXPERIMENTAL

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.

Drug: SCT800 and Daratumumab

SCT800 alone

ACTIVE COMPARATOR

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

Drug: SCT800

Interventions

SCT800 and Daratumumab DRUG

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

Also known as: Immune tolerance induction combine anti-CD38

SCT800 combined with Daratumumab

SCT800 DRUG

SCT800 50IU/kg TIW alone

Also known as: Immune tolerance induction only

SCT800 alone

Eligibility Criteria

• Age: 14 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Moderate or severe hemophilia A;
• Aged 14-66 years old;
• Inhibitor positive at 2 consecutive visits;
• Inhibitor titer \> 10 BU at the screening visit.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Institute of Hematology & Blood Diseases Hospital, China: lead
• Sinocelltech Ltd.: collaborator

Study Sites (1)

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

Tianjin, China

RECRUITING

MeSH Terms

Interventions

daratumumab

Study Officials

• Lei Zhang

  Chinese Academy of Medical Science and Blood Disease Hospital

  PRINCIPAL INVESTIGATOR

• Renchi Yang

  Chinese Academy of Medical Science and Blood Disease Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Wei Liu

CONTACT

+8613820261971; liuwei1@ihcams.ac.cn

Lei Zhang

CONTACT

zhanglei1@ihcams.ac.cn

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 24, 2023
• First Posted: June 5, 2023
• Study Start: November 22, 2023
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: February 24, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: from 12 months to 36 months after study completion
• Access Criteria: From corresponding author

Locations

CN (1)