Study on the Use of Simoctocog Alfa and Emicizumab for Surgery in Patients with Severe Hemophilia A

3 1 1 1

What is this study about?

This clinical trial is focused on studying the treatment of Hemophilia A, a genetic disorder that affects the blood’s ability to clot properly. The study involves the use of a medication called Nuwiq, which is a form of Coagulation Factor VIII. This medication is administered as a solution for injection and is used in combination with another medication called Emicizumab, which is already being used regularly by the patients participating in the study.

The purpose of the study is to evaluate how effective Nuwiq is in managing bleeding during and after major surgery in patients with severe Hemophilia A who are already on Emicizumab prophylaxis. Participants will receive Nuwiq through an intravenous injection, which means it is delivered directly into a vein. The study will monitor the patients’ response to the treatment over a period of time, focusing on how well the medication helps control bleeding during surgery.

Throughout the study, researchers will assess the overall success of the treatment by observing the patients’ bleeding control during surgery and any side effects that may occur. The study will also track the levels of Coagulation Factor VIII in the blood before and after the Nuwiq injections. The trial is expected to continue until March 2025, providing valuable insights into the effectiveness of this treatment approach for individuals with severe Hemophilia A.

1 joining the trial

Upon joining the study, you will be informed about the trial’s purpose, which is to evaluate the effectiveness of Nuwiq in combination with ongoing emicizumab treatment for managing bleeding during major surgery in patients with severe haemophilia A.

2 pre-surgery preparation

Before your surgery, you will continue your regular emicizumab treatment. You will also receive Nuwiq through an intravenous injection. The specific dosage will depend on your individual needs and will be determined by the medical team.

3 surgery day

On the day of your surgery, you will receive Nuwiq injections before and after the procedure. The medical team will monitor your FVIII levels, which are important for blood clotting, to ensure they are at the right levels for surgery.

4 post-surgery monitoring

After your surgery, the medical team will continue to monitor your condition closely. You will receive additional Nuwiq injections as needed to maintain proper blood clotting. Your response to the treatment will be assessed using a scale to determine its effectiveness.

5 follow-up assessments

Throughout the trial, you will have regular follow-up visits to assess your health and the effectiveness of the treatment. The medical team will check for any side effects or complications, such as the formation of inhibitors against FVIII or any thrombotic events.

Who Can Join the Study?

Must have severe haemophilia A. This means having very low levels of a protein called factor VIII (less than 1%) in the blood, according to medical history.
Must be a male who is at least 12 years old.
Must have been treated with any factor VIII product for at least 150 exposure days. An exposure day is any day you receive treatment with factor VIII.
Must be on regular preventive treatment with a medication called emicizumab for at least 3 months before a planned major surgery that requires factor VIII treatment.
Must provide written informed consent. This means you agree to participate in the study after being fully informed about it.

Who Cannot Join the Study?

Patients who do not have severe haemophilia A cannot participate. Severe haemophilia A is a condition where the blood does not clot properly, leading to excessive bleeding.
Only male patients can participate. Female patients are not eligible.
Patients who are part of a vulnerable population cannot participate. A vulnerable population includes groups like children, pregnant women, or those unable to give consent.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country	Status
IRCCS Humanitas Research Hospital	Rozzano	Italy
Azienda Ospedaliero Universitaria Careggi	Florence	Italy

Other Sites

Site Name	City	Country
KBC Zagreb	Zagreb	Croatia
Virgen del Rocío University Hospital	Sevilla	Spain
Centre Hospitalier Universitaire De Nantes	Nantes	France
Vxfxpeit Nudqoopp fkka Gooznelbji Gpdf	Berlin	Germany
Hltkibpr Uvxvmiqvbm Cotcumb Hlnbfzhg	Helsinki	Finland
Cvjsff Hdistgfvzna Rwmcnhvt Ugntxipionvod Dr Tpipi	Tours	France
Unwyudwpoh Mrlpjcr Clhmdg Hvauiasdlybsfnqua	Hamburg	Germany
Uwunzispkr Mpfav Gvvyyfq Ow Cdixmtgja	Catanzaro	Italy
Fcobxccks Pabo Lt Imhspwgrlruns Bhpguidrn Dwf Hstsvqyc Uqfqjxhusibjd Lj Pqn	Madrid	Spain

Trial status

Country	Status	Recruitment Start
Croatia	Recruiting	01.06.2023
Finland	Recruiting	01.06.2023
France	Recruiting	01.06.2023
Germany	Recruiting	01.06.2023
Italy	Recruiting	01.06.2023
Spain	Recruiting	01.06.2023

Trial locations

Investigated drugs:

Simoctocog Alfa

Nuwiq is a medication used to help control bleeding in people with hemophilia A, a condition where the blood does not clot properly. It works by providing a protein that is missing in people with this condition, which helps the blood to clot and stop bleeding. In this trial, Nuwiq is being used to manage bleeding during and after surgery in patients who are already receiving another treatment called emicizumab.

Emicizumab is a medication used to prevent bleeding in people with hemophilia A. It works by helping the blood to clot more effectively, reducing the risk of bleeding episodes. In this study, emicizumab is being used as a regular treatment to prevent bleeding, and its effectiveness is being evaluated in combination with Nuwiq during surgical procedures.

Haemophilia A – Haemophilia A is a genetic bleeding disorder caused by a deficiency of clotting factor VIII. This deficiency leads to prolonged bleeding after injuries, surgery, or even spontaneously in severe cases. The disease primarily affects males, as it is linked to the X chromosome. Individuals with Haemophilia A may experience frequent nosebleeds, easy bruising, and joint bleeds, which can cause pain and swelling. Over time, repeated joint bleeds can lead to joint damage and reduced mobility. The severity of the disease varies depending on the level of factor VIII activity in the blood.

Trial ID:

2022-502060-21-00

Protocol code:

GENA-22

Trial Phase:

Therapeutic confirmatory (Phase III)

Other Trials to Consider

#1 Clinical Trials Search in Europe

Study on the Use of Simoctocog Alfa and Emicizumab for Surgery in Patients with Severe Hemophilia A

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?