Ongoing, recruitingTherapeutic use (Phase IV)Interventional

HU-F-AIM - A prospective, interventional study to evaluate HU-resistance in polycythemia vera patients who meet predictive parameters identified in the machine learning project PV-AIM

This study, called HU-F-AIM, is for people in the UK who have a blood condition called polycythaemia vera. Researchers want to understand better why some patients don't respond well to a common medicine called hydroxycarbamide, or find its side effects too difficult to manage. They are observing how many patients become resistant or intolerant to hydroxycarbamide within 6 to 9 months of starting it for the first time. The study uses special 'predictors' identified by a previous computer project to try and spot these patients early on. By doing this, doctors hope to learn how to choose the most effective treatments for individual patients right from the start, making sure they get the best care for their condition.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic use (Phase IV)

Sponsor

Novartis Pharma GmbH

Enrolment target

300

Start

17 May 2023

Polycythemia vera

What is this study about?

This study, called HU-F-AIM, is looking closely at a common medicine called hydroxycarbamide, which is often used to treat a blood condition called polycythaemia vera. Polycythaemia vera causes your body to make too many red blood cells, making your blood thicker and increasing the risk of problems like blood clots. Hydroxycarbamide helps to control this.

However, for some people, hydroxycarbamide doesn't work as well as expected, or they experience side effects that are too difficult to manage. When this happens, doctors say the patient has 'resistance' or 'intolerance' to the medicine. The main goal of this study is to see how many people with polycythaemia vera, who are starting hydroxycarbamide for the first time, develop this resistance or intolerance within about 6 to 9 months.

What makes this study particularly interesting is that it's using information from an earlier computer project (called PV-AIM). This project identified certain signs or 'predictors' that might tell doctors early on if a patient is likely to become resistant to hydroxycarbamide. By gathering more information, the researchers hope to improve how doctors choose treatments for patients with polycythaemia vera, aiming to give everyone the most effective care from the very beginning.

Key takeaways

The study helps understand how hydroxycarbamide works for polycythaemia vera.
It aims to identify patients who might not respond well to the treatment early on.
You would receive standard care and medication, not new treatments.
Your health and treatment response will be closely monitored.
The study lasts up to 15 months.
This research could help doctors choose better treatments for future patients.

Who may be eligible?

To be part of this study, you need to be an adult, 18 years old or older. The study welcomes both men and women.

You would also need to have been diagnosed with polycythaemia vera. The researchers are specifically looking for people who are just starting treatment with hydroxycarbamide for this condition, meaning you haven't taken it before.

Your doctor will check if you meet all the specific requirements for the study based on your health and medical history. This is to make sure the study is a good fit for you and that the results will be accurate.

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 18 years old or older?
Do you have a diagnosis of polycythaemia vera?
Are you about to start hydroxycarbamide for the first time?
Are you generally healthy enough to participate in a clinical study?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you won't be taking a new or experimental medicine, as hydroxycarbamide is already a standard treatment. Instead, the researchers will carefully follow your progress while you receive your usual care.

This will involve regular visits to your doctor and clinic, as you would generally have for polycythaemia vera. During these visits, your medical team will assess how well hydroxycarbamide is working for you and if you're experiencing any side effects. They will also look for the 'predictors' that might suggest if the medicine might not work as well for you over time.

The study will follow you for up to 15 months. This means that for over a year, your doctors will be recording information about your treatment and how you are feeling, helping them to understand more about hydroxycarbamide treatment in people with polycythaemia vera.

Potential risks and benefits

Taking part in this study may offer the benefit of very close monitoring of your polycythaemia vera and your treatment with hydroxycarbamide, which could give you extra reassurance. There are no new or unknown risks associated with the study itself, as you would be receiving standard treatment. However, any potential risks would be those usually associated with hydroxycarbamide treatment for polycythaemia vera, which your doctor will discuss with you. You are free to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

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Unverified
Germany

Common questions

What is polycythaemia vera?

It's a rare blood condition where your body makes too many red blood cells, making your blood thicker and increasing the risk of clots.

What is hydroxycarbamide?

It's a common medicine used to control the number of blood cells your body makes in conditions like polycythaemia vera.

What does 'resistance/intolerance' mean?

It means the medicine isn't working effectively anymore, or the side effects are too severe to continue taking it.

Will I be given a new medicine in this study?

No, you will receive hydroxycarbamide, which is a standard and approved treatment for polycythaemia vera.

How long will the study last for me?

You will be followed for a maximum of 15 months while you receive your normal medical care.