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.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Ages | 0 Years to 18 Years |
| Sex | Men only |
| Enrollment | 110 (estimated) |
| Sponsor | Beijing Children's Hospital Academic / other |
| Drugs / interventions | emicizumab, emercizumab, rituximab, Daratumumab |
| Locations | 1 site (Beijing, Beijing Municipality) |
| Status | Recruiting |
| Started | March 1, 2025 |
| Main results expected | March 1, 2028 |
| Study ends | June 21, 2028 |
| Registry record updated | March 7, 2025 |
| Trial ID | NCT06864975 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
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Beijing Children's hospitial
Beijing, Beijing Municipality, China Recruiting
Study contacts
- Study coordinator: Dr. Wu
- Email: runhuiwu@hotmail.com
- Phone: +86 010-59616623
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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Treatment for Hemophilia A in Adolescents and Adults with High Titer Inhibitor
This study is testing if a new treatment for hemophilia A, using a drug called SCT800 alone or with another drug called Daratumumab, can help teenagers and adults with high titer inhibitors feel better and have fewer relapses.
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Using SEVENFACT® to treat bleeding in hemophilia patients with inhibitors
This study is testing if SEVENFACT® can safely help people aged 12 and older with hemophilia who have inhibitors stop bleeding during episodes.
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Evaluating the effects of a treatment on bone health in patients with severe hemophilia A
This study is testing how a new treatment for severe hemophilia A affects bone and joint health over time to help make monitoring easier for patients.
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Understanding antibody changes in hemophilia A patients treated with emicizumab
This study looks at how the immune system reacts to emicizumab treatment in people with severe hemophilia A by checking leftover samples from their regular doctor visits.
-
Looking at chronic pain in adults with severe haemophilia A
This project will see if chronic pain in adults with severe haemophilia A who have been on bispecific monoclonal antibodies is linked to pain catastrophising, confidence in managing pain, and body image.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.