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NCT Number: NCT05888870

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

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.

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Key information

Conditions

Hemophilia A With Inhibitor

Age range

14 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

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

Tianjin, China

Location status: Recruiting

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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.

Treatment and study plan

SCT800 and Daratumumab

Drug

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

Other names: Immune tolerance induction combine anti-CD38

SCT800

Drug

SCT800 50IU/kg TIW alone

Other names: Immune tolerance induction only

Primary outcomes

  1. 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

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

    Time frame: 3 months

    Inhibitor titre <0.6 BU⁄mL

Secondary outcomes

  1. ITI success time

    Time frame: 12 months

    time to successful tolerance

Interested in participating?

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Sponsors and collaborators

Lead sponsor

Institute of Hematology & Blood Diseases Hospital, China

Other

Collaborators

  • Sinocelltech Ltd.

Registry information

Official study 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

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Jun 5, 2023
Registry last updated
Feb 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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