Testing SCT800 with or without daratumumab in hemophilia A with inhibitors
Tests two treatment plans to reduce inhibitors in teens and adults with hemophilia A.
Plain-language title generated from the registry record
Registry title: ITI Using SCT800 Alone or Combining Daratumumab in Hemophilia A Adolescents and Adults With High Titer Inhibitor
Key facts
- Where
- Tianjin, ChinaSee the site
- Phase
- Phase 4
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 14 and 65 years old?
Source: NCT05888870, who can take part
Where in China
- Institute of Hematology and Blood Diseases Hospital, Chinese Academy of Medical Sciences and Peking Union Medical CollegeTianjin, ChinaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Institute of Hematology & Blood Diseases Hospital, China
- Trial code
- NCT05888870
- Record updated
- 24 February 2025
- Original description
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.Read full original descriptionShow less
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
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.
Inclusion: Moderate or severe hemophilia A; Aged 14-66 years old; Inhibitor positive at 2 consecutive visits; Inhibitor titer > 10 BU at the screening visit.
Exclusion: The patient has contraindications to drug ingredients or hamster protein allergy; Suffering from other immune diseases or Using immunosuppressant IS to treat another disease(s); Failed systemic ITI treatment in history; Poor patients compliance; The investigator believes that there are any other reasons that make the patient unsuitable to participate in this study.