NCT06864975 Assessing Different FVIII Doses and Frequencies in Immune Tolerance Induction (ITI) with ADVATE Among Hemophilia a Boys with Inhibitor (INITIATE Study)
| NCT ID | NCT06864975 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Runhui WU |
| Condition | Hemophilia a with Inhibitor |
| Study Type | INTERVENTIONAL |
| Enrollment | 110 participants |
| Start Date | 2025-03-01 |
| Primary Completion | 2028-03-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 110 participants in total. It began in 2025-03-01 with a primary completion date of 2028-03-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Hemophilia A is a blood coagulation disorder caused by deficient or dysfunctional clotting factor VIII (FVIII) leading to incomplete haemostasis. Patients with severe Hemophilia A are predisposed to recurrent bleeding episodes (BEs) in joints and soft tissues that culminate in debiltating arthropathy and long-term morbidity. Prophylaxis with plasma-derived or recombinant FVIII concentrates effectively restores FVIII levels in patients with Hemophilia A, and significantly reduces the risk of bleeding. A critical concern for patients receiving FVIII replacement therapy is the development of neutralising antibodies (inhibitors) against the treatment. Inhibitors develop in up to 40% of patients with severe Hemophilia A when first exposed to FVIII treatment, typically within the first 20-30 exposure days (EDs) although a residual risk remains until after 75 EDs. Inhibitors preclude the use of FVIII replacement therapy for prevention and treatment of bleeding. Eradication of inhibitors therefore remains an important objective for Hemophilia A patients with inhibitors. Immune tolerance induction (ITI) therapy is the only clinically proven strategy for inhibitor eradication, and at least one attempt should be offered to patients with inhibitors. However, while ITI is well-studied and has a 60- 80% success rate, treatment regimens can be expensive and burdensome to patients. There are limited data on the use of different dose regimen of FVIII ITI in China. The INITIATE Study was designed to observe treatment strategies in patients with hemophilia A with inhibitors, with a focus on evaluating the safety and effectiveness of different dose regimens of ITI. The INITIATE Study includes multiple groups to explore factors that may affect ITI outcomes, and to explore the effects of different treatment methods on patient ITI biomarkers (genomics, transcriptomics, proteins (antibodies).
Eligibility 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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06864975 clinical trial?
This trial is open to male participants only, aged 0 Years or older, up to 18 Years, studying Hemophilia a with Inhibitor. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06864975 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT06864975 currently recruiting?
Yes, NCT06864975 is actively recruiting participants. Contact the research team at runhuiwu@hotmail.com for enrollment information.
Where is the NCT06864975 trial being conducted?
This trial is being conducted at Beijing, China.
Who is sponsoring the NCT06864975 clinical trial?
NCT06864975 is sponsored by Runhui WU. The trial plans to enroll 110 participants.