BridgeMD
A research study looking at how safe it is to switch from emicizumab to Mim8 in people with haemophilia A (FRONTIER 5).
EU CTIS ID: 2022-502450-13-00
What this study is testing
To evaluate the safety of Mim8 prophylaxis during emicizumab washout in adults and adolescents with haemophilia A with or without FVIII inhibitors who have switched directly from prophylaxis with emicizumab.
- Therapeutic confirmatory (Phase III)
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
- Informed consent obtained before any study-related activities. Study-related activities are any procedures that are carried out as part of the study, including activities to determine suitability.
- Male or female with diagnosis of congenital haemophilia A of any severity based on medical records.
- Age 12 years or above at the time of signing the informed consent.
- Patients treated with emicizumab QW, Q2W, or Q4W according to the label for at least 8 weeks prior to screening.
- Patients for whom the decision to discontinue emicizumab treatment has been made.
- Participant and/or caregiver willingness and ability to comply with scheduled visits and study procedures, including the completion of an electronic diary and patient-reported outcomes.
You likely can't join if
- Participation (i.e., signed informed consent) in any interventional, clinical study, with the exception of emicizumab, with receipt of the last dose within 8 weeks (or 5 half-lives of the investigational medicinal product [IMP], whichever is longer) before screening.
- Known or suspected hypersensitivity to study intervention, related products, any constituents of the product or to other monoclonal antibodies.
- Hepatic dysfunction defined as aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) >3 times the upper limit combined with total bilirubin >1.5 times the upper limit measured at screening.
- Renal impairment defined as estimated glomerular filtration rate (eGFR) ≤30 mL/min/1.73 m2 for serum creatinine measured at screening.
- Female who is pregnant, breast-feeding or intends to become pregnant or is of childbearing potential and not using highly effective contraceptive method.
- Mental incapacity, unwillingness to cooperate, or a language barrier precluding adequate understanding and cooperation.
See the full eligibility criteria
- Informed consent obtained before any study-related activities. Study-related activities are any procedures that are carried out as part of the study, including activities to determine suitability.
- Male or female with diagnosis of congenital haemophilia A of any severity based on medical records.
- Age 12 years or above at the time of signing the informed consent.
- Patients treated with emicizumab QW, Q2W, or Q4W according to the label for at least 8 weeks prior to screening.
- Patients for whom the decision to discontinue emicizumab treatment has been made.
- Participant and/or caregiver willingness and ability to comply with scheduled visits and study procedures, including the completion of an electronic diary and patient-reported outcomes.
- Participation (i.e., signed informed consent) in any interventional, clinical study, with the exception of emicizumab, with receipt of the last dose within 8 weeks (or 5 half-lives of the investigational medicinal product [IMP], whichever is longer) before screening.
- Known or suspected hypersensitivity to study intervention, related products, any constituents of the product or to other monoclonal antibodies.
- Hepatic dysfunction defined as aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) >3 times the upper limit combined with total bilirubin >1.5 times the upper limit measured at screening.
- Renal impairment defined as estimated glomerular filtration rate (eGFR) ≤30 mL/min/1.73 m2 for serum creatinine measured at screening.
- Female who is pregnant, breast-feeding or intends to become pregnant or is of childbearing potential and not using highly effective contraceptive method.
- Mental incapacity, unwillingness to cooperate, or a language barrier precluding adequate understanding and cooperation.
- Other conditions (e.g. autoimmune disease) or laboratory abnormality that may increase risk of bleeding or thrombosis as evaluated by the investigator.
- Any disorder, which in the investigator’s opinion might jeopardise the participant’s compliance with the protocol or safety, including ongoing AEs associated with emicizumab.
- Previous participation in this study. Participation is defined as signed informed consent.
- Known congenital or acquired coagulation disorders other than haemophilia A.
- Previous or current thromboembolic disease or eventsa (with the exception of previous catheter-associated thrombosis for which anti-thrombotic treatment is not currently ongoing) or risk of thromboembolic disease, as evaluated by investigator.
- Neutralising antibodies towards emicizumab have been detected or, for patients adherent to emicizumab therapy, are suspected based on clinical and laboratory assessments.
- Receipt of FVIII gene therapy at any time.
- Ongoing or planned immune tolerance induction therapy.
- Minor or major surgery planned to take place after screening and during the 26-week treatment period
The study team makes the final eligibility decision.
Where it's taking place
- United Kingdom
- Japan
- United States
- South Africa
- Korea, Republic of
- Canada
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 all sexes, 65+ years, 18-64 years, 0-17 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include United Kingdom; Japan; United States; South Africa; Korea, Republic of; Canada. 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.