NCT05888870 ITI Using SCT800 Alone or Combining Daratumumab in Hemophilia A Adolescents and Adults With High Titer Inhibitor
| NCT ID | NCT05888870 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Institute of Hematology & Blood Diseases Hospital, China |
| Condition | Hemophilia A With Inhibitor |
| Study Type | INTERVENTIONAL |
| Enrollment | 50 participants |
| Start Date | 2023-11-22 |
| Primary Completion | 2026-12-01 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 50 participants in total. It began in 2023-11-22 with a primary completion date of 2026-12-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
Inclusion Criteria 1. Moderate or severe hemophilia A; 2. Aged 14-66 years old; 3. Inhibitor positive at 2 consecutive visits; 4. Inhibitor titer \> 10 BU at the screening visit. Exclusion Criteria: 1. The patient has contraindications to drug ingredients or hamster protein allergy; 2. Suffering from other immune diseases or Using immunosuppressant IS to treat another disease(s); 3. Failed systemic ITI treatment in history; 4. Poor patients compliance; 5. The investigator believes that there are any other reasons that make the patient unsuitable to participate in this study.
Contact & Investigator
Lei Zhang
PRINCIPAL INVESTIGATOR
Chinese Academy of Medical Science and Blood Disease Hospital
Frequently Asked Questions
Who can join the NCT05888870 clinical trial?
This trial is open to participants of all sexes, aged 14 Years or older, up to 65 Years, studying Hemophilia A With Inhibitor. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05888870 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT05888870 currently recruiting?
Yes, NCT05888870 is actively recruiting participants. Contact the research team at liuwei1@ihcams.ac.cn for enrollment information.
Where is the NCT05888870 trial being conducted?
This trial is being conducted at Tianjin, China.
Who is sponsoring the NCT05888870 clinical trial?
NCT05888870 is sponsored by Institute of Hematology & Blood Diseases Hospital, China. The principal investigator is Lei Zhang at Chinese Academy of Medical Science and Blood Disease Hospital. The trial plans to enroll 50 participants.