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Efficacy and Safety of Immune Tolerance Induction Combined with Anti-CD38 and Anti-CD20 Monoclonal Antibodies for Eradication of Hemophilia Inhibitors

Efficacy and Safety of Immune Tolerance Induction Combined with Anti-CD38 and Anti-CD20 Monoclonal Antibodies for Eradication of Hemophilia Inhibitors

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2500108398
Enrollment
Unknown
Registered
2025-08-29
Start date
2025-09-01
Completion date
Unknown
Last updated
2025-09-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hemophilia

Interventions

Hemophilia A inhibitor subjects receiving ITI treatment for the first time:NA
Hemophilia A inhibitor subjects receiving rescue treatment:NA
Hemophilia B inhibitor subjects:NA

Sponsors

Beijing Children's Hospital Affiliated to Capital Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
No minimum to 18 Years

Inclusion criteria

Inclusion criteria: 1. Hemophilia A inhibitor subjects receiving ITI treatment for the first time: (1) hemophilia A severe (FVIII: C= 200BU, (4) inhibitors have not shown a decreasing trend after 3 months of ITI treatment, (5)FVIII immune tolerance induction therapy (FVIII 100IU/kg. QD or other regimen), combined with rituximab 375mg/m^2 each time, maximum single dose 600mg once a week for 2 weeks, and daratumumab 16mg/kg once a week for 2 weeks. 2. Hemophilia A inhibitor subjects receiving salvage treatment: (1) hemophilia A severe (FVIII: C= 100BU or re elevated or recurrent after 4-6 months of rituximab treatment; (4) Receive FVIII immune tolerance induction therapy (FVIII 100IU/kg. QD or other regimen) in combination with daratumumab 16mg/kg once a week for 4 consecutive weeks. 3. Hemophilia B inhibitor subjects: (1) hemophilia B severe (FIX: C= 0.6BU/ml. (4) Daretomumab 16mg/kg, once a week for 4 consecutive weeks, to be inhibited combined with FIX preventive treatment after the substance turns negative.

Exclusion criteria

Exclusion criteria: Merge with other coagulation related diseases, hematological disorders, autoimmune diseases, malignant tumors, etc.

Design outcomes

Primary

MeasureTime frame
Inhibitor;

Countries

China

Contacts

Public ContactRunhui Wu

Beijing Children's Hospital Affiliated to Capital Medical University

zekunli@foxmail.com+86 139 1138 3480

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026