RecruitingPHASE4INTERVENTIONAL

Nuwiq Dosing and Outcomes In the ManagEment of Women/Girls With Haemophilia A Needing FVIII Treatment for Surgery

This study is for women and girls aged 12 and older who have hemophilia A and are planning to have major surgery. The main goal is to see how effectively Nuwiq, a special medication, prevents bleeding during and after these operations. Doctors involved in the study want to understand the best way to use Nuwiq to keep patients safe when they need surgery. This includes understanding how much G-CSF is needed and if it works consistently for different types of operations, including C-sections for pregnant women with haemophilia A. This information helps doctors provide the best care for women and girls with hemophilia A.

At a glance

Status

Recruiting

Phase

PHASE4

Sponsor

Octapharma

Enrolment target

Start

01 Apr 2026

Estimated completion

01 Feb 2027

Hemophilia A

What is this study about?

If you are a woman or girl with hemophilia A, you know that managing bleeding can be an important part of your life, especially around medical procedures. When you have major surgery, your doctors often need to give you extra medication to help your blood clot normally and prevent too much bleeding. This study is looking at one specific medication called Nuwiq, which is a type of factor VIII.

Nuwiq is already approved and used to treat hemophilia A. This study isn't testing a new, unknown drug. Instead, it's focusing specifically on how well Nuwiq works for women and girls with hemophilia A when they need major surgery. Doctors want to understand the best way to use Nuwiq in these situations, including the right dose and how effective it is at preventing bleeding during and after the operation. This is important because managing hemophilia A during surgery needs careful planning to ensure the best possible outcome.

The information gathered from this study will help healthcare professionals better understand how to use Nuwiq for women and girls with hemophilia A undergoing surgery. This could lead to clearer guidelines and improved care, making these procedures safer and less stressful for patients. The study aims to confirm that Nuwiq is a reliable and effective option for preventing bleeding in these specific circumstances.

Key takeaways

This study explores Nuwiq use in women and girls (12+) with hemophilia A for major surgery.
It aims to understand how well Nuwiq prevents bleeding during operations.
Nuwiq is an existing, approved treatment for hemophilia A.
Participation involves receiving Nuwiq and close medical monitoring.
Information gained will help improve care for patients like you.

Who may be eligible?

To join this study, you need to be a woman or girl at least 12 years old and have hemophilia A. This includes cases where your factor VIII levels are a bit higher (between 40% and 50%) but you still have a history of bleeding problems that are typical for hemophilia A. You must also be scheduled for a major surgery where your doctor believes you'll need treatment to help your blood clot, and this can include planned C-sections for pregnant women.

There are also some reasons why you might not be able to join. For example, if you have another bleeding disorder besides hemophilia A, or if you've previously developed antibodies (called inhibitors) to factor VIII. You also can't join if you have very severe liver or kidney problems, or if you're allergic to Nuwiq or its ingredients. If you've already had surgery in this specific study, are currently in another medical study, or have been given an experimental drug in the last 30 days, you wouldn't be able to take part.

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 a woman or girl at least 12 years old?
Do you have hemophilia A?
Are you scheduled for major surgery where factor VIII treatment is needed?
Have you *not* developed antibodies (inhibitors) to factor VIII?
Do you *not* have severe liver or kidney problems?
Are you *not* allergic to Nuwiq or its ingredients?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will receive Nuwiq as treatment to prevent bleeding during your major surgery. The study involves monitoring your health closely before, during, and after your operation to see how well the medicine works and to check for any side effects. This will include regular check-ups and blood tests. The exact number of visits and tests will depend on your specific surgery and recovery, but the study will fully outline this for you. All participants will be followed for a period after their surgery to ensure all outcomes are recorded.

Potential risks and benefits

Potential benefits of taking part include receiving careful monitoring and established treatment with Nuwiq during your surgery, which aims to effectively prevent bleeding. This could help ensure a smoother surgical experience. Potential risks are generally low, as Nuwiq is an approved medication. However, as with any medicine, there is a small chance of side effects or allergic reactions. Your health will be closely watched throughout the study to quickly address any concerns. Remember, you can choose to leave the study at any time, for any reason, without it affecting your usual medical care.

Locations (16)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

UT Health San Antonio
Verified postcode
San Antonio, United States· Recruiting
Helsinki University Hospital,Coagulation Disorder Unit
Verified postcode
Helsinki, Finland· Recruiting
Avenue de la République
Verified postcode
Chambray-lès-Tours, France· Recruiting
CHU de Nantes Hôtel-Dieu
Verified postcode
Nantes, France· Recruiting
Chu de Strasbourg
Unverified
Stasbourg, France· Not yet recruiting
Universitätsklinikum Bonn,Institut für Experimentelle Haematologie und Transfusionsmedizin
Verified postcode
Bonn, Germany· Recruiting
Gerinnungszentrum Rhein-Ruhr
Verified postcode
Duisburg, Germany· Recruiting
Universitätsklinikum Hamburg Eppendorf,II. Medizinische Klinik und Poliklinik
Verified postcode
Hamburg, Germany· Recruiting
Aziendo Ospedaliera "Puglieze Ciaccio"
Verified postcode
Catanzaro, Italy· Recruiting
Policlinico "P. Giaconne"
Verified postcode
Palermo, Italy· Recruiting
Clinical Center for Serbia
Verified postcode
Belgrade, Serbia· Recruiting
Hospital Universitario la Paz
Verified postcode
Madrid, Spain· Recruiting

Common questions

What is Nuwiq?

Nuwiq is a laboratory-produced version of factor VIII, a protein that helps blood clot, used to treat hemophilia A.

Is this study for new medicine?

No, Nuwiq is already an approved medicine. This study is looking at how best to use it for women and girls needing surgery.

Can pregnant women join the study?

Yes, if they have hemophilia A and are having a planned caesarean section, they may be able to participate.

What kind of surgery is included?

The study includes various major surgeries, both planned and emergency, where factor VIII treatment is needed.

Will I get special care if I join?

Yes, you will receive very careful monitoring of your condition and treatment with Nuwiq during your surgery and recovery.

How to find out more

Cristina Solomon

cristina.solomon@octapharma.com +41795859042 Official trial record

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