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

Sponsor
Institute of Hematology & Blood Diseases Hospital (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05888870
Collaborator
Sinocelltech Ltd. (Industry)
50
Enrollment
2
Arms
42
Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: SCT800 and Daratumumab
 Phase 4

Detailed Description

This is a randomized controlled trial to compare the outcome of immune tolerance induction therapy using 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 Design

Study Type:
Interventional
Anticipated Enrollment :
50 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
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 Randomized Controlled Trial
Anticipated Study Start Date :
Jun 1, 2023
Anticipated Primary Completion Date :
Dec 1, 2026
Anticipated Study Completion Date :
Dec 1, 2026

Arms and Interventions

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

    		•
    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 and Daratumumab
    SCT800 50IU/kg TIW alone or treated with Daratumumab 8mg/kg 4-8 times
    Other Names:
  • Immune tolerance induction

    		•

    Outcome Measures

    Primary Outcome Measures

    1. success rate of ITI success rate of ITI success rate of ITI success rate of ITI [12 months]

      Inhibitor titre <0.6 BU⁄mL

    2. Success rate and partial sucess rate of ITI after 3-month treatment [3 months]

      Inhibitor titre <0.6 BU⁄mL

    Secondary Outcome Measures

    1. ITI success time [12 months]

      time to successful tolerance

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    14 Years to 65 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No

    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.

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Institute of Hematology & Blood Diseases Hospital
    • 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 Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Zhang Lei, MD, Professor/Vice director of Thrombosis &Hemostasis Center, Institute of Hematology & Blood Diseases Hospital
    ClinicalTrials.gov Identifier:
    NCT05888870
    Other Study ID Numbers:
    • SCT800-AITI
    First Posted:
    Jun 5, 2023
    Last Update Posted:
    Jun 5, 2023
    Last Verified:
    May 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Hemophilia A
    Daratumumab

    Study Results

    No Results Posted as of Jun 5, 2023