Actively Recruiting

Phase 4
Age: 14Years - 65Years
All Genders
NCT05888870

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

Led by Institute of Hematology & Blood Diseases Hospital, China · Updated on 2025-02-24

50

Participants Needed

1

Research Sites

157 weeks

Total Duration

On this page

Sponsors

I

Institute of Hematology & Blood Diseases Hospital, China

Lead Sponsor

S

Sinocelltech Ltd.

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 14Years - 65Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Moderate or severe hemophilia A
  • Aged 14 to 66 years old
  • Positive for inhibitors at two consecutive visits
  • Inhibitor titer greater than 10 Bethesda Units at screening visit
Not Eligible

You will not qualify if you...

  • Allergy or contraindications to study drugs or hamster protein
  • Having other immune diseases or using immunosuppressants for other conditions
  • Previous failure of systemic immune tolerance induction treatment
  • Poor compliance with treatment requirements
  • Any other reason deemed by the investigator to make participation unsuitable

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

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

Tianjin, China

Actively Recruiting

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Research Team

W

Wei Liu

CONTACT

L

Lei Zhang

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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