Assessing Different FVIII Doses and Frequencies in Immune Tolerance Induction (ITI) with ADVATE Among Hemophilia a Boys with Inhibitor (INITIATE Study)

PHASE4RecruitingINTERVENTIONAL

Enrollment

110

Participants

Timeline

Start Date

March 1, 2025

Primary Completion Date

March 1, 2028

Study Completion Date

June 21, 2028

Conditions

Hemophilia a with Inhibitor

Interventions

DRUG

Advate®

Non-daily dose FVIII 50IU/kg.QoD or 100IU/kg.QoD

DRUG

Advate®

Daily dose FVIII 50IU/kg.QD or 100IU/kg.QD

DRUG

Advate®

Low dose FVIII 50IU/kg.QD or 100IU/kg.QoD

DRUG

Advate®

Medium and high dose FVIII ≥100IU/kg.QD

DRUG

Advate®

Medium and high dose FVIII ≥100IU/kg.QD with immunosuppressant agent(s)

Trial Locations (1)

RECRUITING

Beijing Children's hospitial, Beijing

All Listed Sponsors

lead

Runhui WU

OTHER