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

Launched by RUNHUI WU · Mar 4, 2025

Keywords

ClinConnect Summary

The INITIATE Study is a clinical trial aimed at understanding how different doses and schedules of a treatment called FVIII (factor VIII) can help boys with severe Hemophilia A who have developed inhibitors. Inhibitors are antibodies that can stop FVIII from working properly, making it difficult to manage bleeding episodes. The goal of this study is to find the safest and most effective ways to help these patients regain tolerance to FVIII, which can help reduce or eliminate the inhibitors. The trial will involve boys aged 0 to 65 who have severe Hemophilia A, have tested positive for FVIII inhibitors, and do not have any serious allergies to FVIII concentrates.

Participants in this study can expect to receive careful monitoring and different treatment regimens to see how well they work. The study aims to gather important information that could help improve future treatments for Hemophilia A. This is a chance for eligible boys to contribute to research that may benefit not only themselves but also others living with this condition in the future.

Gender

MALE

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