Concizumab for Hemophilia
(explorer8 Trial)
Trial Summary
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications. However, if you are in the group that continues with normal medicine, you will keep taking your usual medication for the first 6 months before starting the study medicine.
What data supports the effectiveness of the drug Concizumab for treating hemophilia?
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, offering a novel approach to managing bleeding episodes.23567
What is the purpose of this trial?
This trial tests concizumab, a new daily injectable medicine, in people with haemophilia A or B without inhibitors. The goal is to see if it can safely prevent bleeding episodes. Participants will either start the new medicine immediately or after a period of time, depending on their current treatment plan. Concizumab has shown significant reduction in bleeding rates in previous trials.
Research Team
Clinical Reporting Anchor and Disclosure (1452)
Principal Investigator
Novo Nordisk A/S
Eligibility Criteria
This trial is for males aged 12 or older with severe haemophilia A (FVIII below 1%) or B (FIX equal to or below 2%), without inhibitors. Participants must consent and be able to inject themselves daily with the study drug, concizumab. They cannot join if they have other coagulation disorders, a history of blood clots, are at high risk for clotting events, or are allergic to ingredients in the trial product.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive concizumab prophylaxis or continue with their normal medicine for 6 months before switching to concizumab
Long-term Treatment
Participants continue concizumab treatment with visits approximately every 8 weeks
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
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