A Study Following Males With Haemophilia A on Prophylaxis With Esperoct®
This study is gathering information about a medicine called Esperoct® (turoctocog alfa pegol (N8-GP)). It's for males of all ages who have haemophilia A and are already taking Esperoct® to prevent bleeds. The aim is to see how well the medicine works over a long time and if there are any side effects. You'll get the same care you normally would, and your doctor will ask about your health and any bleeds since your last visit. You'll also keep a diary of your bleeds. The study will last about 5 to 7 years. You can choose to leave the study at any time, and it won't affect your medical care.
At a glance
What is this study about?
This study is about a medicine called Esperoct® (sometimes known as turoctocog alfa pegol or N8-GP). It's specifically for males who have haemophilia A. Haemophilia A is a condition where your blood doesn't clot properly, leading to easier bleeding. Esperoct® is a treatment given regularly to help prevent these bleeds.
The main goal of this study is to collect information over a long time – around 5 to 7 years – about how well Esperoct® works in preventing bleeds and whether it causes any side effects. Doctors want to understand its long-term effects in people using it as part of their regular treatment to prevent bleeds.
It's important to know that taking part in this study means you'll continue to get the same medical care and treatment as you usually would. The study is simply looking at how Esperoct® is used in real life. Your participation helps doctors learn more about this medicine to help others with haemophilia A in the future.
Key takeaways
- This study is for males with haemophilia A who use Esperoct®.
- It aims to understand Esperoct®'s long-term effectiveness and side effects.
- Your treatment and medical care won't change if you join.
- You'll share information about your bleeds and health over 5-7 years.
- Participation is voluntary, and you can leave at any time without affecting your care.
- Your involvement helps improve understanding of haemophilia A treatment.
Who may be eligible?
This study is for males of any age who have been diagnosed with moderate or severe haemophilia A. You must already be using or be about to start using the regular preventive treatment, Esperoct®. The decision for you to use Esperoct® must have been made by you and your doctor independently, before you decide to join this study.
Before you can take part, you'll need to read and sign a consent form, showing you understand what's involved. This is a very important step to make sure you're comfortable with everything.
You cannot join the study if you've been in it before, or if you're allergic to Esperoct® or similar medicines. Also, if your doctor suspects you have 'inhibitors' (antibodies that stop the medicine from working) or if you have difficulty understanding the study information, you won't be able to participate.
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?
- Do you have moderate or severe haemophilia A?
- Are you currently using or about to start using Esperoct® for regular prevention?
- Has the decision to use Esperoct® already been made by you and your doctor?
- Are you comfortable signing a consent form to participate?
- Do you understand the study information and feel able to cooperate?
What does participation involve?
If you decide to join this study, it means you'll continue with your usual medical appointments and treatment with Esperoct® as prescribed by your doctor. The study doesn't change your treatment plan. Your clinic visits will be just like your normal check-ups.
During these visits, the study doctor might ask you some questions about your health and if you've had any side effects since your last visit. They might also suggest some routine tests if they think it's helpful. You'll be asked to keep a simple diary at home, noting down any bleeds you have, how you treated them, and when you took your regular Esperoct® medicine.
Your participation in this study will last for quite a while, typically between 5 to 7 years, depending on when you start. You have the right to leave the study at any time, for any reason, and this decision will not affect your current or future medical care in any way.
Potential risks and benefits
Locations (27)
- AKH - Klin. Abt. f. Haematologie u. HaemostaseologieVerified postcodeVienna, Austria
- UMHAT "Tsaritsa Yoanna-ISUL"Verified postcodeSofia, Bulgaria
- KBC Zagreb, Rebro, Hemofilija centarVerified postcodeZagreb, Croatia
- FN Brno odd. hematologieVerified postcodeBrno, Czechia
- FN HK - IV. Interni hematologicka klinikaVerified postcodeHradec Králové, Czechia
- North Estonia Medical Centre FoundationVerified postcodeTallinn, Estonia
- Tartu University Hospital Haematology ClinicVerified postcodeTartu, Estonia
- Vivantes Netzwerk für Gesundheit GmbH - Vivantes Klinikum im FriedrichshainVerified postcodeBerlin, Germany
- Universitätsklinikum Bonn - Institut für Experimentelle HämatologieVerified postcodeBonn, Germany
- "Laiko" General Hospital of AthensVerified postcodeAthens, Greece
- "Laiko" General Hospital of AthensVerified postcodeAthens, Greece
- Aghia Sophia Childrens' HospitalVerified postcodeAthens, Greece
Common questions
What is Esperoct®?
Esperoct® is a medicine used to prevent bleeding in people with haemophilia A.
Do I have to do anything differently with my medicine if I join?
No, you will continue to take Esperoct® exactly as your doctor has prescribed; the study doesn't change your treatment.
How long will the study last for me?
The study will last for about 5 to 7 years, depending on when you start.
Can I leave the study whenever I want?
Yes, you are free to leave the study at any time, for any reason, and it won't impact your medical care.
What information will I need to share?
You'll be asked about any bleeds and side effects, and to keep a diary of your bleeds and when you take your medicine.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
Discussion
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