A Research Study Looking at How Different Doses of Study Medicine (Inno8) Work in the Body of People With Haemophilia A
This research is investigating a new medicine, Inno8, for individuals living with haemophilia A. The primary purpose is to understand how various doses of Inno8 affect the body and to ensure it is safe for use. Inno8 is a new medicine, not yet available from doctors, and this early-stage study will help us learn more about it. Participants will be involved for approximately 11 weeks. The study focuses on adult men aged 18 to 64 who have haemophilia A. This is an important step in developing new treatments that could potentially help people manage their condition better in the future.
At a glance
What is this study about?
This research study is focused on a new medicine called Inno8, which is being developed to treat haemophilia A. Haemophilia A is a condition where your blood doesn't clot properly, leading to longer bleeding after injuries and sometimes bleeding inside the body.
The main aim of this study is to learn more about how Inno8 works in the body and to find out if it's safe for people with haemophilia A. Because Inno8 is a new medicine, it’s not yet available on prescription from your doctor. Studies like this are a really important first step in bringing new treatments to patients.
By taking part, you would help doctors and scientists understand what dose of Inno8 might be most effective and safest. This kind of research is vital for improving future treatments and quality of life for people with haemophilia A. The study lasts for about 11 weeks.
Key takeaways
- This study is testing a new medicine called Inno8 for men with haemophilia A.
- The main goals are to check the medicine's safety and how it works in the body.
- It's an early-stage study for a medicine not yet available from doctors.
- Participation will involve clinic visits and lasts about 11 weeks.
- Strict eligibility criteria apply, focusing on adult men with haemophilia A.
- Your participation could help advance understanding and treatment of haemophilia A.
Who may be eligible?
To join this study, we are looking for adult men aged between 18 and 64 years old. You must have been diagnosed with haemophilia A, and your condition should involve your Factor VIII level being 15% or less. You would also need to weigh at least 45 kilograms (about 7 stone 1 pound).
There are certain reasons why someone might not be able to join. For example, if you've recently used other preventative treatments for haemophilia A, or if you have a Body Mass Index (BMI) of 30 or higher. You also wouldn't be able to participate if you have a higher risk of blood clots, or other blood clotting problems besides haemophilia A, or if you are currently having (or planning to have) a specific type of treatment called immune tolerance induction therapy.
The research team will carefully check all these details to make sure the study is right for you and that you meet all the necessary requirements.
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 man?
- Are you between 18 and 64 years old?
- Do you have haemophilia A with Factor VIII activity of 15% or less?
- Do you weigh at least 45 kilograms (about 7 stone 1 pound)?
- Have you spoken to the study team about your full medical history?
What does participation involve?
If you decide to take part, the study will last for around 11 weeks. This will involve several visits to the clinic where the research team will monitor your health closely. You will be given the study medicine, Inno8, and they will collect blood samples to see how the medicine is working in your body. There will also be other health checks throughout the study to ensure your safety and monitor your progress. The exact number and frequency of visits will be explained in detail by the study team, along with what each visit will involve.
Potential risks and benefits
Locations (33)
- UC Denver Hemoph & Thrombo CtrVerified postcodeAurora, United States· Not yet recruiting
- Indiana Hemophilia-Thromb CtrVerified postcodeIndianapolis, United States· Recruiting
- University of Iowa_Iowa CityVerified postcodeIowa City, United States· Recruiting
- Penn State MS Hershey Med CtrVerified postcodeHershey, United States· Recruiting
- St Christopher Hosp for ChildVerified postcodePhiladelphia, United States· Not yet recruiting
- Universitätsklinik für Innere Medizin VVerified postcodeInnsbruck, Austria· Recruiting
- AKH - Klin. Abt. f. Haematologie u. HaemostaseologieVerified postcodeVienna, Austria· Recruiting
- Cliniques universitaires Saint-LucVerified postcodeBrussels, Belgium· Not yet recruiting
- HCL - HOPITAL LOUIS PRADEL - Unité d'hémostase CliniqueVerified postcodeBron, France· Not yet recruiting
- Vivantes Netzwerk für Gesundheit GmbH - Vivantes Klinikum im FriedrichshainVerified postcodeBerlin, Germany· Recruiting
- Universitätsklinikum Bonn - Institut für Experimentelle HämatologieVerified postcodeBonn, Germany· Not yet recruiting
- Medizinische Hochschule Hannover - Hämatologie, Hämostaseologie, OnkologieVerified postcodeHanover, Germany· Recruiting
Common questions
What is haemophilia A?
Haemophilia A is a genetic bleeding disorder where your blood doesn't clot properly due to a lack of a specific protein called Factor VIII. This can lead to prolonged bleeding after injury or surgery, and sometimes internal bleeding.
What is Inno8?
Inno8 is the name of the new medicine being tested in this study. It's a new treatment option for haemophilia A that is still under investigation and not yet available for general use by doctors.
How long does the study last?
The study is planned to last for about 11 weeks in total for each participant, including all visits and follow-up.
Will I get paid to participate?
The study information doesn't mention payment, but it's common for studies to cover travel expenses. This is a good question to ask the study team if you are interested in participating.
Can women participate in this study?
No, this particular study is specifically looking for male participants within the specified age range.
How to find out more
Novo Nordisk
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
Discussion
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