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The efficacy of intermediate-dose immune tolerance induction with domestical recombinant coagulation factor VIII in severe hemophilia A children with high-titer inhibitors: a multicenter single arm study

The efficacy of intermediate-dose immune tolerance induction with domestical recombinant coagulation factor VIII in severe hemophilia A children with high-titer inhibitors: a multicenter single arm study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300072205
Enrollment
Unknown
Registered
2023-06-06
Start date
2023-07-01
Completion date
Unknown
Last updated
2023-06-18

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

Conditions

Hemophilia

Interventions

Intermediate-dose ITI group:Intermediate-dose ITI (rFVIII 100IU/kg/day). When triggering the upgrade indicator, increase immunosuppressive agents.

Sponsors

Beijing Children's Hospital, affiliated to Capital Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
No minimum to 14 Years

Inclusion criteria

Inclusion criteria: i. severe hemophilia A ii. age at 0-=14 years old iii. peak historical inhibitor titer =5-<200BU iv. have not received ITI therapy before

Exclusion criteria

Exclusion criteria: i. with other immunological disease ii. receive immunosuppressants for reasons not related to this study iii. Major surgical treatment is required during the study period iv. Currently receiving ITI treatment v. other circumstances

Design outcomes

Primary

MeasureTime frame
ITI success/partial success rate;The time to success/partial success;—

Secondary

MeasureTime frame
Breakthrough bleedings;Joint;Cost;Quality of life;PICC;—

Countries

China

Contacts

Public ContactRunhui Wu

Beijing Children's Hospital

runhuiwu@hotmail.com+86 133 7011 5037

Outcome results

None listed

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