At a glance
ClinicalIndex Comparison RecordPhase 4Recruiting· 50 target
Drug / intervention
SCT800 and Daratumumab +1 moredrug
Likely dose
SCT800 and Daratumumab 50IUfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
Institute of Hematology & Blood Diseases Hospital, China·interventional·Posted Jun 5, 2023·Updated Feb 24, 2025
In Brief
A Phase 4 clinical trial evaluating SCT800 and Daratumumab and SCT800 for Hemophilia A With Inhibitor. Currently recruiting, targeting 50 participants across 1 site.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHemophilia A With Inhibitor
CountriesChina
CollaboratorsSinocelltech Ltd.
Timeline
Phase 4Recruiting
2024202520262027
First PostedJun 2023
Enrollment StartNov 2023
TodayJul 2026
Primary CompletionDec 2026
First PostedJun 5, 2023
Enrollment StartNov 22, 2023
Primary CompletionDec 1, 2026
TodayJul 1, 2026
Enrollment to primary: 3.0 yearsPosted 3.1 years agoPrimary completion in 5 months
Interventions
SCT800 and Daratumumabdrug
SCT800 50IU/kg TIW alone or treated with Daratumumab 8mg/kg 4-8 times
SCT800drug
SCT800 50IU/kg TIW alone