Concizumab for Hemophilia
(explorer7 Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests concizumab, a new medicine, in people with hemophilia A or B who have inhibitors. It aims to see if concizumab can prevent bleeding by helping the blood clot more effectively. Concizumab has shown good results in earlier studies for hemophilia A and B.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop your current medications. However, if you usually take medicine to prevent bleeds, you will start the study medicine right away. If you take medicine only when you have a bleed, you might continue your normal medicine for the first 6 months.
How is the drug Concizumab unique for treating hemophilia?
Concizumab is unique because it is a monoclonal antibody that targets the tissue factor pathway inhibitor (TFPI), which helps restore normal blood clotting in hemophilia patients. Unlike traditional treatments that replace missing clotting factors, Concizumab is administered subcutaneously (under the skin) and works by inhibiting TFPI to promote clot formation, offering a novel approach to managing bleeding episodes.12345
What data supports the effectiveness of the drug Concizumab for treating hemophilia?
Who Is on the Research Team?
Clinical Reporting Anchor and Disclosure (1452)
Principal Investigator
Novo Nordisk A/S
Are You a Good Fit for This Trial?
This trial is for males aged 12 or older with Hemophilia A or B and inhibitors, who have used bypassing agents in the last 24 weeks. It's not for those with thromboembolic disease, high risk of blood clots, ongoing immune treatments, hypersensitivity to similar drugs, or other coagulation disorders.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive daily concizumab injections under the skin, which they administer themselves at home. The treatment phase includes randomization into different groups, with some starting concizumab immediately and others after 6 months.
Follow-up
Participants are monitored for safety and effectiveness after treatment, including recording information in an electronic diary and possibly wearing an activity tracker.
Extension
Participants in the extension part receive daily concizumab injections, continuing the treatment regimen.
What Are the Treatments Tested in This Trial?
Interventions
- Concizumab
Concizumab is already approved in European Union, United States, Canada for the following indications:
- Hemophilia A with inhibitors
- Hemophilia B with inhibitors
- Hemophilia A with factor VIII inhibitors
- Hemophilia B with factor IX inhibitors
- Hemophilia A with inhibitors
- Hemophilia B with inhibitors
Find a Clinic Near You
Who Is Running the Clinical Trial?
Novo Nordisk A/S
Lead Sponsor
Lars Fruergaard Jørgensen
Novo Nordisk A/S
Chief Executive Officer since 2017
MSc in Finance and Business Administration, Aarhus School of Business, Aarhus University, Denmark
Martin Holst Lange
Novo Nordisk A/S
Chief Medical Officer since 2021
MD from University of Copenhagen