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RecruitingPHASE4INTERVENTIONAL

Nuwiq for Perioperative Management Of Patients With Haemophilia A on Emicizumab Regular Prophylaxis Study

This study is investigating a medicine called Nuwiq, a type of clotting factor VIII, to see how well it prevents bleeding during major surgery. It's for males aged 12 and over who have severe haemophilia A and are already receiving regular treatment with another medication called emicizumab. When someone with haemophilia A who is on emicizumab needs a major operation, doctors often give them extra clotting factor VIII to make sure they don't bleed too much during and after the surgery. This study aims to understand the best way to use Nuwiq in these situations to keep patients safe. It's a single-group study, meaning everyone involved will receive Nuwiq alongside their usual emicizumab treatment.

At a glance

Status
Recruiting
Phase
PHASE4
Sponsor
Octapharma
Enrolment target
28
Start
28 Nov 2023
Estimated completion
01 Sep 2026

What is this study about?

If you have severe haemophilia A and are already getting regular treatment with emicizumab, you might be interested in this study. Sometimes, even with regular emicizumab, if you need a big operation, doctors still give extra clotting medicine to prevent bleeding during and after the surgery. This study is looking at a specific medicine called Nuwiq, which is a type of clotting factor VIII, to see how well it works to stop bleeding when patients like you have major surgery.

The main goal is to check how effective Nuwiq is in preventing bleeding during and right after surgery for people with severe haemophilia A who are already on emicizumab. This is important because it helps doctors understand the best and safest way to manage surgery for patients with haemophilia A on this specific treatment plan. By taking part, you would be helping medical science learn more about how to best care for people with haemophilia A undergoing operations.

This study will involve a group of male patients aged 12 and over who have severe haemophilia A and are scheduled for major surgery. Everyone in the study will receive Nuwiq, along with their usual emicizumab treatment, before, during, and after their operation. Researchers will carefully monitor how well the Nuwiq works to prevent bleeding and will check for any side effects. This information will help improve care for future patients.

Key takeaways

  • Looks at how well Nuwiq controls bleeding during surgery for haemophilia A patients.
  • For males aged 12+ with severe haemophilia A already on emicizumab.
  • Aims to understand the best way to use clotting factor VIII with emicizumab during operations.
  • Everyone in the study will receive Nuwiq at the time of their surgery.
  • Participation involves extra monitoring and tests related to the study.

Who may be eligible?

This study is looking for male patients aged 12 and older who have been diagnosed with severe haemophilia A and have had treatment with a factor VIII medicine for at least 150 days in the past. You also need to be on regular treatment with emicizumab for at least a month before your planned major surgery.

There are some reasons why you might not be able to join. For example, if you have another bleeding disorder that isn't haemophilia A, or if you've ever had problems with inhibitors (antibodies that stop your haemophilia medicine from working) in the past. You also can't take part if you have serious liver or kidney disease, or if you're allergic to any of the ingredients in Nuwiq. If you've already had surgery as part of this study, or if you're currently in another medical study or have taken part in one very recently, you wouldn't be able to join this one.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

  1. Are you male and at least 12 years old?
  2. Do you have severe haemophilia A?
  3. Have you used a Factor VIII product for at least 150 days in the past?
  4. Are you currently on regular emicizumab treatment for at least a month?
  5. Are you planning to have a major elective surgery soon?
  6. Have you never had an 'inhibitor' (antibodies that stop haemophilia medicine)?
Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would first have a screening visit to make sure you're eligible. Once accepted, you would receive Nuwiq alongside your regular emicizumab treatment, specifically timed for your major surgery. This would involve getting Nuwiq infusions before, during, and after your operation, as decided by your medical team. You would have regular check-ups by the study team, who would monitor your bleeding, your recovery from surgery, and look for any side effects. These check-ups would involve blood tests and physical examinations. The total duration of your participation would depend on your surgical recovery and follow-up plan, but the main focus is around the time of your surgery and the immediate recovery period.

Potential risks and benefits

Taking part in this study may offer the benefit of receiving carefully monitored treatment with Nuwiq during your major surgery, potentially ensuring good control of bleeding. However, as with any medical treatment, there are potential risks, including side effects from Nuwiq or complications related to surgery. The study involves extra medical appointments and tests beyond your usual care. You will be fully informed of all known risks and benefits before deciding to participate, and you have the right to withdraw from the study at any time, for any reason, without affecting your regular medical care.

Locations (18)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.
  • UT Southwestern Medical Center
    Verified postcode
    Dallas, United States· Recruiting
  • University Hospital Centre Zagreb
    Verified postcode
    Zagreb, Croatia· Recruiting
  • Helsinki University Hospital
    Verified postcode
    Helsinki, Finland· Recruiting
  • CHU de Nantes Hôtel-Dieu
    Verified postcode
    Nantes, France· Recruiting
  • CHRU de Tours
    Verified postcode
    Tours, France· Recruiting
  • Vivantes Klinikum im Friedrichshein (KFH)
    Verified postcode
    Berlin, Germany· Recruiting
  • Gerinnungszentrum Rhein-Ruhr
    Verified postcode
    Duisburg, Germany· Recruiting
  • Universitätsklinikum Hamburg Eppendorf (UKE)
    Verified postcode
    Hamburg, Germany· Recruiting
  • Christian Medical College Vellore
    Verified postcode
    Vellore, India· Recruiting
  • St. John's Medical College Hospital
    Verified postcode
    Bengaluru, India· Recruiting
  • Azienda Ospedaliera Pugliese Ciaccio
    Verified postcode
    Catanzaro, Italy· Recruiting
  • Azienda Ospedaliero Universitaria Careggi - Centro Emofilia
    Verified postcode
    Florence, Italy· Recruiting

Common questions

What is Nuwiq?

Nuwiq is a medicine that helps your blood clot. It's a man-made version of a natural clotting factor called factor VIII, which is missing or doesn't work properly in people with haemophilia A.

Why is this study only for males?

Haemophilia A is an inherited condition that almost exclusively affects males. Therefore, this study, like many haemophilia A studies, focuses on the population most affected.

Will I still take my emicizumab?

Yes, if you're already taking emicizumab regularly, you will continue to do so alongside receiving Nuwiq for your surgery.

What kind of surgery is included?

This study is for people undergoing major surgery, which means operations that carry a higher risk of bleeding and therefore require careful management.

Who is running this study?

This is a multinational study, meaning it's being conducted in several countries by a team of doctors and researchers, sponsored by the company that makes Nuwiq.

How to find out more

Sigurd Knaub, PhD

Always speak to your GP or specialist before deciding to take part in a study.

Interested in taking part?

Register your interest

Share your details and the research team for "Nuwiq for Perioperative Management Of Patients With Haemophi…" will contact you if you may be eligible. Always speak to your GP before agreeing to take part.

Discussion

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