BridgeMD
An international investigator initiated trial to capture different approaches in the treatment of Haemophilia A Patients With FVIII Inhibitors
EU CTIS ID: 2024-516741-39-00
What this study is testing
The primary objective for Groups 1 and 2 is to evaluate ITI outcomes as determined by achievement of the following ITI criteria: 1. Inhibitor titre < 0.6 Bethesda units (BU)/mL for at least 2 consecutive measurements 2. FVIII recovery ≥ 66% of the predefined reference value of 1.5% international units (IU)/kg body weight (BW) 3. FVIII half-life ≥ 6 h The primary objective for Group 3 is to evaluate the annualised bleeding rate (ABR) compared with the ABR in Group 1 and Group 2.
- Therapeutic use (Phase IV)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 1. Participants can be of any age at the time of enrolment into the trial. 2. Male persons with hemophilia A (HA), of any severity, who have a historical inhibitor titre ≥ 0.6 BU/mL, including those who have failed previous ITI attempt(s) 3. Persons undergoing ITI with Nuwiq®, octanate® or wilate® or undergoing ITI with Nuwiq®, octanate® or wilate® and receiving prophylactic therapy with emicizumab, aPCC or rFVIIa 4. Participants or participants’ parent(s)/legal guardian(s) must be capable of giving signed informed consent and be able to understand the trial documents
You likely can't join if
- 1. Participants are excluded from the trial if any coagulation disorder other than HA is diagnosed 2. Partly retrospective patients will be excluded if detailed documentation on treatment, all BEs, inhibitor titres and FVIII levels is not available for the retrospective period
The study team makes the final eligibility decision.
Where it's taking place
- Colombia
- Canada
- Mexico
- United States
- Ukraine
- Switzerland
- Guatemala
- United Kingdom
- North Macedonia
- Saudi Arabia
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, 65+ years, 0-17 years, 18-64 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Colombia; Canada; Mexico; United States; Ukraine; Switzerland and 4 more location(s). 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 EU CTIS; the study team decides eligibility.