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Study on the Use of Simoctocog Alfa for Women and Girls with Hemophilia A Undergoing Surgery

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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 treatment of hemophilia A, a genetic disorder that affects the blood's ability to clot properly, in women and girls who need surgery. The treatment being tested is called Nuwiq, which is a medication used to help the blood clot by providing a protein known as coagulation factor VIII. This study aims to evaluate how effective Nuwiq is in managing bleeding during and after surgery in patients with hemophilia A.

Participants in the study will receive Nuwiq through an intravenous injection, which means it will be administered directly into a vein. The study will observe the effects of Nuwiq during the surgery and the recovery period afterward. The treatment period for each participant is expected to last up to 30 days. The study will also monitor for any side effects or complications that may arise from the treatment.

The goal of this study is to gather information on the overall effectiveness of Nuwiq in controlling bleeding during surgical procedures in women and girls with hemophilia A. This information will help healthcare providers better understand how to manage bleeding in these patients during surgery. The study is open-label, meaning both the participants and the researchers know which treatment is being administered, and it is not controlled, so all participants will receive Nuwiq without a comparison to a placebo or another treatment.

The research process

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

Step 1
Joining the study
Upon joining the study, you will be informed about the trial's purpose and procedures. You will need to provide written consent to participate.
The study focuses on evaluating the effectiveness of Nuwiq in managing bleeding during surgery for women and girls with haemophilia A.
Step 2
Pre-surgery preparation
Before your surgery, you will receive Nuwiq through an intravenous injection. This means the medication will be administered directly into your vein.
The dosage of Nuwiq will be determined by the medical team based on your specific needs.
Step 3
Surgery
During the surgery, the medical team will monitor the effectiveness of Nuwiq in controlling bleeding.
The surgical team will assess the bleeding control using a specific scale to ensure the medication is working as expected.
Step 4
Post-surgery monitoring
After the surgery, you will continue to receive Nuwiq as needed to manage bleeding.
The medical team will monitor your recovery and the healing of your surgical wound.
Step 5
Follow-up assessments
You will have regular follow-up visits to assess the overall effectiveness of Nuwiq in managing bleeding during and after surgery.
The medical team will also check for any side effects or complications, such as the formation of inhibitors against the medication.
Step 6
Completion of participation
Your participation in the study will conclude once your surgical wound has healed and all necessary assessments have been completed.
The study is expected to end by March 2025, but your individual participation may conclude earlier depending on your recovery.

Who can join the trial?

5 criteria

Must be a woman or girl with Haemophilia A. This means having a specific condition where the blood does not clot properly.
Must have a Factor VIII activity level between 1% and less than 40%. Factor VIII is a protein that helps blood to clot.
Must be at least 12 years old.
Must be scheduled to have major elective surgery. This is a planned surgery that is not an emergency.
Must provide written informed consent. This means agreeing to participate in the study after understanding all the details.

Who cannot join the trial?

4 criteria

Patients who do not have Haemophilia A cannot participate. Haemophilia A is a condition where the blood does not clot properly.
Only women and girls can participate. Men and boys are not eligible.
Participants must be within certain age ranges. If you are not in the specified age group, you cannot join.
If you are part of a vulnerable population, you may not be eligible. This means groups that might need special protection or care.

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Verified sites

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Verified
Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone
Palermo, Italy
Verified
Azienda Provinciale Per I Servizi Sanitari
Trento, Italy
Responsive
Fundacion Para La Investigacion Biomedica Del Hospital Universitario La Paz
Madrid, Spain

Trial locations

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Investigated drugs

Nuwiq is a medication used to help people with hemophilia A, a condition where the blood does not clot properly. This medication provides a protein called Factor VIII, which is missing or not working well in people with this condition. By giving the body this protein, Nuwiq helps the blood to clot more normally, which is especially important during surgeries to prevent excessive bleeding. In this clinical trial, the focus is on how well Nuwiq works in women and girls with hemophilia A who need this treatment during major surgeries.

Simoctocog Alfa

What is already known about the treatment

Nuwiq – Nuwiq is administered as an injection into a vein, typically used to manage bleeding in individuals with Haemophilia A, especially during surgery. It is currently recognized in medical literature as an effective treatment for this condition. The main therapeutic indication for Nuwiq is to help control bleeding in patients with Haemophilia A by providing a replacement for the missing or defective factor VIII, a protein essential for blood clotting. At the molecular level, Nuwiq works by supplementing the body with factor VIII, which helps the blood to clot properly. It is classified pharmacologically as a recombinant factor VIII product.

Investigated diseases

Haemophilia A – Haemophilia A is a genetic bleeding disorder caused by a deficiency of clotting factor VIII, which is essential for blood clotting. This condition leads to prolonged or spontaneous bleeding episodes, often into joints and muscles. The severity of bleeding can vary, with some individuals experiencing frequent and severe bleeding, while others may have milder symptoms. Bleeding episodes can occur after injuries or surgeries, but in severe cases, they may happen without any apparent cause. Over time, repeated bleeding into joints can lead to joint damage and chronic pain. The condition is typically inherited in an X-linked recessive pattern, primarily affecting males.