NCT05888870RecruitingPhase 4
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
Source: ClinicalTrials.gov · Last updated 24 Feb 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 50 (estimated)
- First submitted
- 24 May 2023
- Start date
- 22 Nov 2023
- Primary completion date
- 1 Dec 2026
- Lead sponsor
- Institute of Hematology & Blood Diseases Hospital, China
- Diseases
- Haemophilia
- NCT number
- NCT05888870
What you commit to
- Study type: Interventional · Phase 4
- Planned participants: 50
- From 22 Nov 2023 to the primary completion date, 1 Dec 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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);
Other
- 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.
Who the study is looking for
- Moderate or severe hemophilia A;
- Aged 14-66 years old;
- Inhibitor positive at 2 consecutive visits;
- Inhibitor titer \> 10 BU at the screening visit.
Age in the registry: 14 years to 65 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Institute of Hematology and Blood Diseases Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College Coordinator of this site? Confirm its status | Tianjin | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.