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
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.
- Are you male and at least 12 years old?
- Do you have severe haemophilia A?
- Have you used a Factor VIII product for at least 150 days in the past?
- Are you currently on regular emicizumab treatment for at least a month?
- Are you planning to have a major elective surgery soon?
- Have you never had an 'inhibitor' (antibodies that stop haemophilia medicine)?
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
Locations (18)
- UT Southwestern Medical CenterVerified postcodeDallas, United States· Recruiting
- University Hospital Centre ZagrebVerified postcodeZagreb, Croatia· Recruiting
- Helsinki University HospitalVerified postcodeHelsinki, Finland· Recruiting
- CHU de Nantes Hôtel-DieuVerified postcodeNantes, France· Recruiting
- CHRU de ToursVerified postcodeTours, France· Recruiting
- Vivantes Klinikum im Friedrichshein (KFH)Verified postcodeBerlin, Germany· Recruiting
- Gerinnungszentrum Rhein-RuhrVerified postcodeDuisburg, Germany· Recruiting
- Universitätsklinikum Hamburg Eppendorf (UKE)Verified postcodeHamburg, Germany· Recruiting
- Christian Medical College VelloreVerified postcodeVellore, India· Recruiting
- St. John's Medical College HospitalVerified postcodeBengaluru, India· Recruiting
- Azienda Ospedaliera Pugliese CiaccioVerified postcodeCatanzaro, Italy· Recruiting
- Azienda Ospedaliero Universitaria Careggi - Centro EmofiliaVerified postcodeFlorence, 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?
Discussion
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