BridgeMD
Research study to look at how well the drug Concizumab works in your body if you have haemophilia without inhibitors
EU CTIS ID: 2023-506831-13-00
What this study is testing
To compare the effect of concizumab prophylaxis to no prophylaxis (on demand treatment with factor) in reducing the number of bleeding episodes in adult and adolescent patients with haemophilia A without inhibitors. To compare the effect of concizumab prophylaxis to no prophylaxis (on demand treatment with factor) in reducing the number of bleeding episodes in adult and adolescent patients with haemophilia B without inhibitors.
- 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 trial-related activities. Trial-related activities are any procedures that are carried out as part of the trial, including activities to determine suitability for the trial
- Male aged ≥12 years at the time of signing informed consent
- Body weight >25 kg at screening
- Congenital severe haemophilia A (FVIII < 1%) or moderate/severe B (FIX ≤ 2%).
- Documented treatment with coagulation factor containing product in the last 24 weeks (not applicable for NN7415-4255 (explorer5) patients enrolled prior to the treatment pause).
You likely can't join if
- Known or suspected hypersensitivity to any constituent of the trial product or related products
- A known systemic inflammatory condition requiring systemic treatment at screening
- Treatment with emicizumab within 180 days before screening
- Presence of confirmed inhibitor ≥0.6 BU at screening
- Known history of inhibitors ≥0.6 BU in the last 5 years according to the medical records.
- Any disorder, except for conditions associated with haemophilia, which in the investigator’s opinion might jeopardise patient’s safety or compliance with the protocol
See the full eligibility criteria
- Informed consent obtained before any trial-related activities. Trial-related activities are any procedures that are carried out as part of the trial, including activities to determine suitability for the trial
- Male aged ≥12 years at the time of signing informed consent
- Body weight >25 kg at screening
- Congenital severe haemophilia A (FVIII < 1%) or moderate/severe B (FIX ≤ 2%).
- Documented treatment with coagulation factor containing product in the last 24 weeks (not applicable for NN7415-4255 (explorer5) patients enrolled prior to the treatment pause).
- Known or suspected hypersensitivity to any constituent of the trial product or related products
- A known systemic inflammatory condition requiring systemic treatment at screening
- Treatment with emicizumab within 180 days before screening
- Presence of confirmed inhibitor ≥0.6 BU at screening
- Known history of inhibitors ≥0.6 BU in the last 5 years according to the medical records.
- Any disorder, except for conditions associated with haemophilia, which in the investigator’s opinion might jeopardise patient’s safety or compliance with the protocol
- Previous participation in this trial. Participation is defined as signed informed consent. However, this is not applicable for patients who were screen failed at Sponsor’s decision due to the treatment pause
- Participation in any clinical trial of an approved or non-approved investigational medicinal product within 5 half-lives or 30 days from screening, whichever is longer (not applicable for NN7415-4255 patients enrolled prior to the treatment pause).
- Platelets ≤100x109/L at screening
- Fibrinogen below laboratory lower normal limit at screening
- Hepatic dysfunction defined as AST and/or ALT >3 times the upper limit combined with total bilirubin > 1,5 times the upper limit at screening
- Renal impairment defined as estimated Glomerular Filtration Rate (eGFR) ≤30 ml/min/1.73 m2 for serum creatinine measured at screening
- Known inherited or acquired coagulation disorder other than congenital haemophilia
- History of thromboembolic disease. Current clinical signs of, or treatment for thromboembolic disease. Patients who in the judgement of the investigator are considered at high risk of thromboembolic events
The study team makes the final eligibility decision.
Where it's taking place
- Canada
- Mexico
- Korea, Republic of
- Turkey
- United Kingdom
- Bosnia and Herzegovina
- Serbia
- India
- Switzerland
- South Africa
- Russian Federation
- Thailand
- Australia
- Malaysia
- United States
- Ukraine
- Japan
- Algeria
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, 18-64 years, 65+ years, 0-17 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Canada; Mexico; Korea, Republic of; Turkey; United Kingdom; Bosnia and Herzegovina and 12 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.