Recruiting PHASE4 Hemophilia a with Inhibitor

New treatment option for Hemophilia a with Inhibitor

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®?

Advate® is an investigational medicine, given as an once-daily infusion into a vein, being studied as a potential treatment for hemophilia a with inhibitor.

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
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.
  • 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's taking place

  • 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 - 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?

Study sites include Beijing, Beijing Municipality, China. Enter your location above to see the nearest site and check your eligibility.

Explore other conditions

BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.