Low-dose ITI Strategy for Children in Hemophilia A With High-titer Inhibitor and Poor ITI Risk in China

• Status: Unknown status
• Trial end date: 2020-12-01
• Target enrollment: 0
• Participant gender: Male

Summary

The study start on January 18, 2017. The Severe(FⅧ<1%) and moderate hemophilia A (FⅧ1%～5%)children with high titer inhibitor(historical peak inhibitor titer≥5BU ) combining with poor ITI risk(s) were enrolled. The low-dose ITI was alone or combined with immunosuppression.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Beijing Children's Hospital
• Treatments: Factor VIII; Prednisone; Rituximab

Criteria

Inclusion Criteria:

• Males

• from 1 to 14 years old

• severe or moderate hemophilia A;

• inhibitors positive before ITI started.

Exclusion Criteria:

• Females

• <1 or >14 years old

• hemophilia B or mild haemophilia A;

• inhibitor negative before ITI started.