Hemophilia a with Inhibitor study: Advate®
Official title Assessing Different FVIII Doses and Frequencies in Immune Tolerance Induction (ITI) with ADVATE Among Hemophilia a Boys with Inhibitor (INITIATE Study)
ClinicalTrials.gov ID: NCT06864975
What this study is testing
What is Advate®?
an investigational dosing regimen of a recombinant factor VIII medicine being studied for hemophilia A patients with inhibitors is designed to replace the missing clotting factor VIII in the blood
Also referred to as recombinant factor VIII, rFVIII.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The study wants to find out how safe and effective various dose regimens of immune tolerance induction are, and to look at related blood markers.
- Who it's for
- Boys who have hemophilia A and have developed inhibitors against factor VIII.
- What's involved
- Participants will receive ADVATE (a clotting factor) at a specific dose and frequency, attend clinic visits, and have blood tests to check safety and response.
- Phase 4: studies an already-approved treatment
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 0 to 18, men only
You may be able to join if
- Severe hemophilia A (FⅧ:C \<2%);
- Positive for FVIII inhibitors;
- No allergic reactions to FVIII concentrates.
You likely can't join if
- Presence of other coagulation-related diseases,
- Hematological disorders,
- autoimmune diseases
- malignancies
The study team makes the final eligibility decision.
Where it is enrolling
- Beijing, Beijing Municipality, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling male, 0 years to 18 years. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Beijing, Beijing Municipality, China. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.