Evaluating FVIII Doses for Immune Tolerance in Hemophilia A Boys with Inhibitors
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
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 |
| Enrollment | 110 (estimated) |
| Ages | 0 Years to 18 Years |
| Sex | Male |
| Sponsor | Beijing Children's Hospital Academic / other |
| Drugs / interventions | emicizumab, emercizumab, rituximab, Daratumumab |
| Locations | 1 site (Beijing, Beijing Municipality) |
| Trial ID | NCT06864975 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates for this study are boys diagnosed with severe Hemophilia A who have developed FVIII inhibitors.
Not a fit: Patients with other coagulation disorders, hematological issues, autoimmune diseases, or malignancies may not benefit from this study.
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 performed: 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.
Eligibility criteria
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 this trial is running
Beijing, Beijing Municipality
- Beijing Children's hospitial — Beijing, Beijing Municipality, China (Recruiting)
Study contacts
- Study coordinator: Dr. Wu
- Email: runhuiwu@hotmail.com
- Phone: +86 010-59616623
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.