IMPAHCT-FUL: A Long-Term Extension, Multi-Center Safety Study of AV-101 in Subjects With Pulmonary Arterial Hypertension (PAH) Who Have Completed Study AV-101-002
This research is a follow-up study for people living with pulmonary arterial hypertension (PAH) who have already taken part in a study involving a new medicine called AV-101. The main goal is to understand the long-term safety of AV-101 and how well people can tolerate it over an extended period. Researchers will also be looking at other important aspects, such as how far people can walk in six minutes, changes in a blood marker called NT-proBNP, and how long it takes for a person's condition to worsen. They will also check heart function using special scans. This is considered a 'Phase III' study, which means it helps confirm if a treatment is safe and effective before it might become more widely available.
At a glance
What is this study about?
This study is called IMPAHCT-FUL and it's looking into a new medicine named AV-101 for a condition called pulmonary arterial hypertension, or PAH. PAH is a serious condition where the blood vessels in the lungs become narrow, making it hard for the heart to pump blood through them. This can make people feel very out of breath and tired. The 'IMPAHCT-FUL' study is a long-term follow-up for people who have already taken part in an earlier study of AV-101.
The main aim of this new study is to closely watch the safety of AV-101 over a longer period. We want to understand if it causes any side effects when taken for a while and how well people tolerate it. To do this, medical teams will be checking various things like how a person feels, their general health, and specific measurements related to their heart and lung condition. This type of study, often called a 'Phase III' study, is really important for confirming if a new medicine is safe and helpful before it can be considered for wider use.
By carefully tracking these details over time, doctors hope to gather more important information about AV-101. This includes how it might affect a person's ability to walk, changes in certain blood tests that tell us about heart strain, and how the medicine might impact the progression of PAH. All this information is crucial for understanding the full picture of AV-101's effects in people with PAH.
Key takeaways
- This study is for people with PAH who have already taken AV-101.
- It aims to understand the long-term safety of AV-101.
- Participation involves regular clinic visits for health checks.
- Important information about heart function and well-being will be collected.
- It's a crucial step in understanding this potential new medicine.
Who may be eligible?
To be able to join this study, everyone must be at least 18 years old. Both men and women can take part.
Crucially, you must have already participated in a previous study of AV-101. This study is designed specifically as a continuation for those individuals, to see how the treatment affects them over a longer time.
The medical team will carefully review your health records from the previous study and conduct some checks to make sure this study is right and safe for you.
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?
- Have you previously taken part in the AV-101-002 study for AV-101?
- Are you able to attend regular clinic appointments?
- Are you a man or a woman?
What does participation involve?
If you decide to take part in this study, you will continue to receive the study medication, AV-101, as you did in the previous trial. You will have regular visits to the clinic, where the medical team will monitor your health closely. These visits will involve various checks, such as blood tests, measuring how far you can walk in six minutes, and having ultrasound scans of your heart. You'll also likely be asked questions about how you are feeling and any changes in your health.
The exact number and timing of visits will be explained to you by the study doctor. There will also be follow-up calls or visits even after you finish taking the study medicine, to continue monitoring your health. The total duration of your participation will depend on the study design, but it is considered a 'long-term extension' study, meaning it will last for a significant period to gather enough safety information.
Potential risks and benefits
Locations (14)
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Common questions
What is Pulmonary Arterial Hypertension (PAH)?
PAH is a condition where the blood vessels in your lungs become narrow, stiff, or blocked, making it harder for blood to flow through. This causes your heart to work harder, leading to symptoms like breathlessness and tiredness.
What is AV-101?
AV-101 is the name of the medicine being studied. It's considered a new or investigational treatment for PAH.
Why is this study only for people who were in another AV-101 study?
This study is a continuation to see how AV-101 affects people over a longer time. It builds on what was learned in the earlier study, focusing on long-term safety.
What does a 'Phase III' study mean?
Phase III means the study is in a later stage of research. It's designed to confirm if a treatment is safe and works well in a larger group of people before it can become a widely available medicine.
Will I get paid to be in the study?
This will be discussed with you by the study team. Some studies cover travel costs, but payment for participation varies.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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