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Study on How Concizumab Works for Patients with Hemophilia A or B Without Inhibitors

Verified siteInvestigationalNo placebo
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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying the effects of a medication called Concizumab in people with a bleeding disorder known as hemophilia. Hemophilia is a condition where the blood does not clot properly, leading to excessive bleeding. The study specifically looks at two types of hemophilia: hemophilia A and hemophilia B, both without inhibitors. Inhibitors are substances that can interfere with the treatment of hemophilia, so this study focuses on patients who do not have these inhibitors.

The purpose of the study is to see how well Concizumab works in reducing the number of bleeding episodes in patients with hemophilia A and B. The medication is given as a solution for injection using a device called the PDS290 pen-injector. Participants in the study will receive either the medication or a placebo, which is a substance with no active drug. The study will compare the effects of taking Concizumab regularly (prophylaxis) to not taking it regularly (on-demand treatment) to see which approach is more effective in preventing bleeding episodes.

Throughout the study, participants will receive injections of Concizumab and will be monitored for any changes in their condition, including the number of bleeding episodes they experience. The study will last for several months, allowing researchers to gather enough information to determine the effectiveness and safety of the medication. This research aims to provide better treatment options for people living with hemophilia, helping them manage their condition more effectively.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    Upon joining the study, informed consent is required. This involves understanding the trial's purpose and agreeing to participate.

    Eligibility criteria include being male, aged 12 years or older, with a body weight over 25 kg, and having severe haemophilia A or moderate/severe haemophilia B without inhibitors.

  2. Step 2

    Initial assessment

    An initial assessment is conducted to confirm eligibility and gather baseline health information.

    This may include medical history review and physical examination.

  3. Step 3

    Randomization

    Participants are randomly assigned to one of two groups: one receiving concizumab prophylaxis and the other receiving on-demand treatment.

    Randomization ensures that each participant has an equal chance of being assigned to either group.

  4. Step 4

    Treatment phase

    For those in the concizumab group, the medication is administered as a subcutaneous injection.

    The dosage is either 100 mg/mL or 40 mg/mL, depending on the specific requirements of the study.

    The treatment duration is at least 32 weeks, with regular monitoring and adjustments as needed.

  5. Step 5

    Monitoring and follow-up

    Participants are monitored for bleeding episodes, injection site reactions, and any hypersensitivity reactions.

    Regular blood tests are conducted to measure concizumab levels and assess the body's response to the treatment.

  6. Step 6

    End of trial

    The trial is expected to conclude by June 2026.

    Final assessments are conducted to evaluate the overall effectiveness and safety of concizumab.

Who can join the trial?

5 criteria

  • You must give your permission to participate in the study before any study-related activities begin. These activities include any procedures done to see if you are suitable for the study.
  • You must be a male who is at least 12 years old at the time you give your permission to participate.
  • Your body weight must be more than 25 kilograms at the time of screening.
  • You must have been born with **severe haemophilia A** (which means your **Factor VIII** level is less than 1%) or **moderate/severe haemophilia B** (which means your **Factor IX** level is 2% or less). **Haemophilia** is a condition where your blood doesn't clot properly.
  • You must have a record of using a product that contains a **coagulation factor** in the last 24 weeks. This requirement does not apply to certain patients who were enrolled before a treatment pause.

Who cannot join the trial?

3 criteria

  • Patients with **haemophilia A** or **haemophilia B** who have **inhibitors**. Inhibitors are substances in the blood that stop the treatment from working properly.
  • Female patients cannot participate in this study.
  • Patients who are considered part of a **vulnerable population**. This means people who might need extra protection or care, like those who cannot make decisions for themselves.
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Investigated drugs

Concizumab is a medication being studied for its ability to prevent bleeding episodes in patients with hemophilia A or B who do not have inhibitors. It is used as a prophylactic treatment, meaning it is given regularly to help prevent bleeding rather than treating bleeding episodes after they occur. The trial aims to see how effective concizumab is compared to not using any prophylactic treatment.

What is already known about the treatment

Concizumab – Concizumab is administered as an injection under the skin, typically used for patients with hemophilia A or B who do not have inhibitors. It is currently being studied in clinical trials to assess its effectiveness and safety in reducing bleeding episodes compared to traditional on-demand treatments. The main therapeutic indication for concizumab is to prevent bleeding in individuals with hemophilia. At the molecular level, concizumab works by inhibiting a protein involved in the blood clotting process, thereby helping to maintain normal clotting function. It is classified as an anticoagulant therapy.

Investigated diseases

  • Haemophilia A

    Haemophilia A is a genetic disorder where the blood does not clot properly due to a deficiency of clotting factor VIII. This condition leads to prolonged bleeding after injuries, surgeries, or even spontaneously without any apparent cause. Individuals with haemophilia A may experience frequent nosebleeds, easy bruising, and bleeding into joints and muscles, which can cause pain and swelling. Over time, repeated joint bleeds can lead to joint damage. The severity of bleeding episodes can vary, with some individuals experiencing mild symptoms and others having more severe bleeding issues.

  • Haemophilia B

    Haemophilia B is a genetic disorder characterized by a deficiency of clotting factor IX, leading to improper blood clotting. Similar to haemophilia A, this condition results in prolonged bleeding after injuries or surgeries and can also cause spontaneous bleeding episodes. Common symptoms include frequent nosebleeds, easy bruising, and bleeding into joints and muscles, which can result in pain and swelling. Repeated joint bleeds may lead to joint damage over time. The severity of symptoms can vary among individuals, with some experiencing mild symptoms and others having more severe bleeding problems.

Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2023-506831-13-00Protocol codeNN7415-4307Estimated enrolment156 patientsSponsorNovo Nordisk A/S

sourced from the EU Clinical Trials Register and site verification

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