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

StatusRecruiting
PhasePhase 4
Started2023-11-22
View on ClinicalTrials.gov ↗

Amendment history

2025-02-20
Study Identification, Study Status, Sponsor/Collaborators v3
Re-verified, no change to tracked fields
2024-01-11
Study Identification, Study Status, Study Description, Study Design v2
Start dateestimated 2023-08-01→confirmed 2023-11-22
Study description+8 characters
This is a non-randomized controlled trial to compare the outcome of immune tolerance induction therapy usingusingnon- SCT800 combined with Daratumumab or SCT800 alone in hemophi [...]
2023-06-18
Not Yet Recruiting→Recruiting Study Identification, Study Status, Arms and Interventions, Outcome Measures, Contacts/Locations v1
Trial statusNot Yet Recruiting→Recruiting
Start date2023-06-01→2023-08-01
Study sites0→1
InterventionsSCT800 and Daratumumab (Drug)→SCT800 (Drug), SCT800 and Daratumumab (Drug)
Primary endpoints2 entries, revised
Success rate and partial sucesssuccess rate of ITI after 3-month treatment
Study title-7 characters
ITI Using SCT800 Alone or Combining Daratumumab or SCT800 Alone in Hemophilia A Adolescents and Adults With High Titer Inhibitor
2023-05-24
Original filing
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.
Trial Details
NCT Number NCT05888870
Lead Sponsor Institute of Hematology & Blood Diseases Hospital, China
Collaborators: Sinocelltech Ltd.
Conditions Hemophilia A With Inhibitor
Enrollment 50 participants
Start Date 2023-11-22
Primary Completion 2026-12-01 (estimated)
Study Completion 2026-12-01 (estimated)
Updated on ClinicalTrials.gov 2025-02-24