Evaluating Effectiveness and Long Term Safety of Damoctocog Alfa Pegol in Patients, Who Have Been Diagnosed With Hemophilia A
This study, called HEM-POWR, is investigating a medicine called Jivi (damoctocog alfa pegol) for people living with haemophilia A. The main goal is to understand how this treatment is used in everyday situations, how well patients tolerate it over time, and how satisfied both patients and their doctors are with its effects. It's an important step in learning more about the long-term benefits and safety of Jivi, helping to improve care for those with haemophilia A. All ages and genders can potentially take part if they meet certain health criteria, and it focuses on real-world treatment experiences.
At a glance
What is this study about?
Haemophilia A is a lifelong inherited bleeding disorder where blood doesn't clot properly. This can lead to unexpected and potentially serious bleeding episodes. Treatments like Jivi (damoctocog alfa pegol) are designed to help the blood clot better, reducing these bleeding risks and allowing people to live fuller lives.
This particular study, known as HEM-POWR, aims to gather real-world information about Jivi. Instead of testing a new drug, it focuses on understanding how Jivi works for people who are already using it or are about to start using it in their daily routine. The researchers want to see how effective it is over a longer period, if people experience any side effects, and generally how patients and their doctors feel about the treatment.
The findings from this study will help healthcare professionals and patients make more informed decisions about treatment options for haemophilia A. By looking at how Jivi performs in everyday life, the study contributes to our overall knowledge of managing this condition and ensuring patients receive the best possible care.
Key takeaways
- The HEM-POWR study looks at Jivi (damoctocog alfa pegol) for haemophilia A.
- It collects real-world information on how Jivi is used and tolerated.
- Focuses on patient and doctor satisfaction with the treatment.
- Aimed at improving long-term understanding of haemophilia A care.
- Open to all ages and genders with haemophilia A, if criteria are met.
Who may be eligible?
To be part of this study, you would need to have a diagnosis of haemophilia A and have received treatment for it before. You might be eligible if you haven't had issues with 'inhibitors' (where your body fights against the treatment) or if you've had them in the past but have been stable on preventive treatment for at least a year. Importantly, you shouldn't currently have any sign or suspicion of these inhibitors.
Another key requirement is that you are either about to start taking Jivi (damoctocog alfa pegol) or are already taking it, whether that's regularly to prevent bleeds, occasionally when a bleed happens, or on an intermittent basis. You would also need to agree to take part and provide your consent.
There are certain reasons why you might not be able to join. For example, if you're already in another study involving new treatments, or if you have other bleeding disorders apart from haemophilia A. Also, if there are specific medical reasons in the UK preventing you from taking Jivi, or if you're currently receiving treatment to get rid of inhibitors, you would not 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.
- I have been diagnosed with Haemophilia A.
- I have been treated for Haemophilia A before.
- I am starting Jivi (damoctocog alfa pegol) or am already taking it.
- I don't currently have complications where my body fights the treatment (inhibitors).
- I'm not currently taking part in another study with new treatments.
- I'm not receiving special treatment for inhibitors right now.
What does participation involve?
This study is designed to observe how Jivi is used in real life, so it mainly involves collecting information about your existing treatment rather than prescribing new tests or specific visits. You would continue to take Jivi as prescribed by your doctor, whether that's regularly, when needed, or occasionally. The study team will gather details about your experience, including how well the medicine works for you and if you have any side effects. This information will likely come from your regular clinic visits and possibly questionnaires about your satisfaction. The total duration of your participation would depend on how long you remain on Jivi as part of your standard care.
Potential risks and benefits
Locations (29)
- South Alabama Medical Science FoundationVerified postcodeMobile, United States
- Banner MD Anderson Cancer CenterVerified postcodePhoenix, United States
- University California DavisVerified postcodeDavis, United States
- Orthopaedic Hospital DBA Orthopaedic Institute for ChildrenVerified postcodeLos Angeles, United States
- The Center for Comprehensive Care and Diagnosis of Inherited Blood DisordersVerified postcodeOrange, United States
- University of Colorado Hemophilia and Thrombosis CenterVerified postcodeAurora, United States
- Georgetown UniversityVerified postcodeWashington D.C., United States
- Tulane UniversityVerified postcodeNew Orleans, United States
- Regents of University of MinnesotaVerified postcodeMinneapolis, United States
- East Carolina University - Brody School of MedicineVerified postcodeGreenville, United States
- Many locationsUnverifiedMultiple Locations, Belgium
- Many locationsUnverifiedMultiple Locations, Brazil
Common questions
What is the main goal of this study?
The main goal is to understand how Jivi (damoctocog alfa pegol) is used in day-to-day life by people with haemophilia A, how safe it is long-term, and how happy patients and doctors are with it.
What is Jivi?
Jivi (damoctocog alfa pegol) is a medicine used to treat haemophilia A, helping blood to clot properly.
Do I need to be taking Jivi already to join?
You can either be about to start taking Jivi or already be using it to be eligible for this study.
Will this study give me new medication?
No, this study observes how Jivi is used in standard care; it doesn't provide new, unapproved medication.
What is an 'inhibitor'?
An inhibitor is when your body's immune system stops the haemophilia medicine from working effectively.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Discussion
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