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

February 20, 2025 updated by: Institute of Hematology & Blood Diseases Hospital, China

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

50

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
      • Tianjin, China
        • Recruiting
        • Institute of Hematology and Blood Diseases Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College
        • Contact:
        • Contact:
        • Principal Investigator:
          • Lei Zhang

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Drug: SCT800 and Daratumumab
SCT800 50IU/kg TIW alone or treated with Daratumumab 8mg/kg 4-8 times
Other Names:
  • Immune tolerance induction combine anti-CD38
Active Comparator: SCT800 alone
ITI using low-dose domestic rFVIII (SCT800) (50IU/kg TIW) alone. Other immunosuppressants could be added after 3 months.
Drug: SCT800
SCT800 50IU/kg TIW alone
Other Names:
  • Immune tolerance induction only

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
success rate of ITI success rate of ITI success rate of ITI success rate of ITI
Time Frame: 12 months
Inhibitor titre <0.6 BU⁄mL
12 months
Success rate and partial success rate of ITI after 3-month treatment
Time Frame: 3 months
Inhibitor titre <0.6 BU⁄mL
3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
ITI success time
Time Frame: 12 months
time to successful tolerance
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Institute of Hematology & Blood Diseases Hospital, China

Collaborators

Sinocelltech Ltd.

Investigators

  • Principal Investigator: Lei Zhang, Chinese Academy of Medical Science and Blood Disease Hospital
  • Principal Investigator: Renchi Yang, Chinese Academy of Medical Science and Blood Disease Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 22, 2023

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

December 1, 2026

Study Registration Dates

First Submitted

May 24, 2023

First Submitted That Met QC Criteria

May 24, 2023

First Posted (Actual)

June 5, 2023

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

February 20, 2025

Last Verified

January 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IIT2022035

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Data can be requested from the corresponding authors from 12 months to 36 months after study completion

IPD Sharing Time Frame

from 12 months to 36 months after study completion

IPD Sharing Access Criteria

From corresponding author

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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