Institute of Hematology and Blood Diseases Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College
Tianjin, China
Location status: Recruiting
Location contact
L Liu
CONTACT
Lei Zhang
PRINCIPAL_INVESTIGATOR
Shuo Chen
CONTACT
NCT Number: NCT05888870
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.
Interested in participating?
Request Info14 year–65 year
All sexes
Interventional
Phase 4
Tianjin, China
Location status: Recruiting
L Liu
CONTACT
Lei Zhang
PRINCIPAL_INVESTIGATOR
Shuo Chen
CONTACT
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
SCT800 50IU/kg TIW alone or treated with Daratumumab 8mg/kg 4-8 times
Other names: Immune tolerance induction combine anti-CD38
SCT800 50IU/kg TIW alone
Other names: Immune tolerance induction only
Time frame: 12 months
Inhibitor titre <0.6 BU⁄mL
Time frame: 3 months
Inhibitor titre <0.6 BU⁄mL
Time frame: 12 months
time to successful tolerance
Contact information is provided by the study sponsor or research team.
Institute of Hematology & Blood Diseases Hospital, China
Other
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
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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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