RecruitingPhase 4NCT05888870

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

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


Sponsor

Institute of Hematology & Blood Diseases Hospital, China

Enrollment

50 participants

Start Date

Nov 22, 2023

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 14 YearsMax Age: 65 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a treatment called immune tolerance induction (ITI) — using a clotting factor product called SCT800, with or without the drug daratumumab — to help the immune system stop attacking clotting factors in people with severe hemophilia A who have developed inhibitors (antibodies that block their treatment from working). **You may be eligible if...** - You are between 14 and 66 years old - You have moderate or severe hemophilia A - You have developed inhibitors (tested positive on two separate visits) - Your inhibitor level is above 10 BU at screening **You may NOT be eligible if...** - You are allergic to any of the drug ingredients or to hamster-derived proteins - You have another immune disorder or are taking immunosuppressive drugs for another condition - You have previously failed a full course of immune tolerance induction therapy - Your level of compliance with treatment is expected to be poor Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGSCT800 and Daratumumab

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

DRUGSCT800

SCT800 50IU/kg TIW alone


Locations(1)

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

Tianjin, China

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NCT05888870


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