Clinical Trials in China / NCT05888870
Recruiting
Phase 4
ITI Using SCT800 Alone or Combining Daratumumab in Hemophilia A Adolescents and Adults With High Titer Inhibitor
NCT05888870 · tracked via the Priya Life Science China tracker
Condition(s) studied
Hemophilia A With Inhibitor
Investigational drug(s) / intervention(s)
SCT800 and DaratumumabSCT800
SCT800 and Daratumumab: SCT800 50IU/kg TIW alone or treated with Daratumumab 8mg/kg 4-8 times
SCT800: SCT800 50IU/kg TIW alone
Study 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
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.
Primary outcome measure(s)
- success rate of ITI success rate of ITI success rate of ITI success rate of ITI — 12 months
Inhibitor titre \<0.6 BU⁄mL - Success rate and partial success rate of ITI after 3-month treatment — 3 months
Inhibitor titre \<0.6 BU⁄mL
Trial sites (1)
| Facility | City | Region | Status |
|---|---|---|---|
| Institute of Hematology and Blood Diseases Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College | Tianjin | China | Recruiting |
More Institute of Hematology & Blood Diseases Hospital, China trials in China
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Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT05888870 on ClinicalTrials.gov ↗ ← All trials in China