Clinical trial Recruiting at 1 site Phase 4 Interventional Ages 0 to 18 Men only

Evaluating FVIII Doses for Immune Tolerance in Hemophilia A Boys with Inhibitors

Official title: Assessing Different FVIII Dose and Frequency in Immune Tolerance Induction (ITI) with ADVATE Among Hemophilia a Boys with Inhibitor (INITIATE Study): a Multicenter Open-label Non-randomized Clinical Trial

Run by Beijing Children's Hospital · NCT06864975 · Data updated 2026-11-12

This study is testing different doses of a treatment for boys with severe Hemophilia A who have developed inhibitors to see if it can help them respond better and reduce bleeding.

More Hemophilia A With Inhibitor trials

Quick facts

PhasePhase 4
Study typeInterventional
Ages0 Years to 18 Years
SexMen only
Enrollment110 (estimated)
SponsorBeijing Children's Hospital
Academic / other
Drugs / interventionsemicizumab, emercizumab, rituximab, Daratumumab
Locations1 site (Beijing, Beijing Municipality)
StatusRecruiting
StartedMarch 1, 2025
Main results expectedMarch 1, 2028
Study endsJune 21, 2028
Registry record updatedMarch 7, 2025
Trial IDNCT06864975 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates for this study are boys diagnosed with severe Hemophilia A who have developed FVIII inhibitors.

Probably not a fit

Patients with other coagulation disorders, hematological issues, autoimmune diseases, or malignancies may not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study aims to assess different doses and frequencies of FVIII (Advate) administration for immune tolerance induction in boys with severe Hemophilia A who have developed inhibitors. The research focuses on understanding how varying treatment regimens can effectively eradicate these inhibitors, which hinder the efficacy of standard FVIII replacement therapy. By monitoring the patients' responses to the treatment, the study seeks to establish optimal dosing strategies that could improve patient outcomes and reduce bleeding episodes. The study is conducted at Beijing Children's Hospital, involving a targeted patient population with specific eligibility criteria.

Why it matters

Potential benefit: If successful, this study could lead to improved treatment protocols that help eradicate inhibitors in Hemophilia A patients, enhancing their quality of life.

How similar studies have gone: Previous studies have shown varying degrees of success with immune tolerance induction strategies, but this specific approach with Advate is being explored for the first time in this context.

Who can join: the full rules

Show full inclusion / exclusion criteria
Inclusion Criteria:

* Severe hemophilia A (FⅧ:C \<2%);
* Positive for FVIII inhibitors;
* No allergic reactions to FVIII concentrates.

Exclusion Criteria:

* Presence of other coagulation-related diseases,
* Hematological disorders,
* autoimmune diseases
* malignancies

Where it's running

  • Beijing Children's hospitial
    Beijing, Beijing Municipality, China
    Recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.