A study to learn how the study medicine called PF-07868489 is tolerated and acts in people with pulmonary arterial hypertension
This research study is investigating a new medicine called PF-07868489 for people living with pulmonary arterial hypertension (PAH). PAH is a serious condition affecting the blood vessels in the lungs, making everyday activities difficult. This study aims to understand how safe the new medicine is and how the body reacts to it. It’s a first-step study (Phase I/II) to help researchers learn more before it can be widely used. Participants must be adults with a confirmed diagnosis of PAH and meet certain health requirements. While the study might not directly benefit participants, it could help develop new treatments for PAH in the future.
Överblick
Vad handlar denna studie om?
This study is exploring a new medicine called PF-07868489. It's for people with a condition called pulmonary arterial hypertension, often shortened to PAH. PAH causes high blood pressure in the arteries leading from your heart to your lungs, which makes your heart work harder and can make you feel breathless and tired. The main goal of this study is to see if this new medicine is safe and how well people tolerate it. Researchers also want to understand how the medicine works inside the body, which is important for developing effective treatments in the future.
This is an early-stage study, known as Phase I/II. This means it's one of the first times the medicine is being tested in people with PAH. Researchers need to gather important information about its safety and effects before it can move on to larger studies. The study information doesn't say exactly what taking part will involve day-to-day, but generally, early studies like this involve close monitoring of your health.
Taking part in studies like this is really important because it helps scientists learn more about new medicines. Even if a new medicine doesn't fully help a participant in the study, the information gathered can still be very valuable for developing better treatments for future patients with PAH.
Viktiga punkter
- It's a study for a new medicine for pulmonary arterial hypertension (PAH).
- The main goals are to check the medicine's safety and how it works.
- It's an early-stage study, so direct benefits might not be known yet.
- Participants must be adults with confirmed PAH and meet specific health criteria.
- Taking part involves clinic visits, tests, and closely monitoring your health.
Vem kan vara berättigad?
To join this study, you need to be at least 18 years old and have a confirmed diagnosis of pulmonary arterial hypertension (PAH). Your PAH should also fit certain types, such as those that are inherited or caused by certain drugs, or if it's linked to other conditions like connective tissue disease.
Your PAH would be classed as either 'WHO functional class II or III', which means it impacts your daily activities moderately or significantly. You would also need to have certain measurements from heart and lung tests, and already be on a stable treatment plan for your PAH. Your body mass index (BMI) should be between 16 and 35. You'll also need to be able to walk a certain distance in six minutes and shouldn't have other serious lung problems.
Before you can officially join, you'll have checks, including a special heart test called a 'right heart catheterisation'. You'll also need to be willing to follow all the study rules, including attending appointments and having specific tests. If you're pregnant, planning to become pregnant, or breastfeeding, you won't be able to take part.
Kan denna studie passa dig?
Svara på dessa snabba frågor för att se om du kan vara berättigad. Detta är endast en vägledning — forskarteamet fattar det slutgiltiga beslutet.
- Är du 18 år eller äldre?
- Do you have a confirmed diagnosis of pulmonary arterial hypertension (PAH)?
- Kan du delta i alla studieavtal och följa instruktionerna?
- Are you currently pregnant, planning to become pregnant, or breastfeeding?
- Are you using effective contraception if you are a woman of childbearing age?
Vad innebär deltagande?
The detailed steps of what taking part involves aren't fully described yet. However, typically in studies like this, you would have regular hospital or clinic visits where you would receive the study medicine, have various health checks, and undergo tests like blood samples, heart scans, and lung function assessments. You would also have a right heart catheterisation at the start and end of the study.
The study medicine, PF-07868489, would likely be given as an injection. The full study is expected to run from November 2024 to January 2027.
Potentiella risker och fördelar
Platser (4)
- Hammersmith sjukhusUngefärligLondon, Storbritannien
- Royal Brompton sjukhusUngefärligLondon, Storbritannien
- Royal Free HospitalUngefärligLondon, Storbritannien
- Golden Jubilee National HospitalUngefärligClydebank, United Kingdom
Vanliga frågor
What is pulmonary arterial hypertension (PAH)?
PAH is a serious condition where blood pressure in the arteries going to your lungs becomes too high, making your heart work harder.
What is PF-07868489?
It's a new medicine being studied to see if it's safe and how it works for people with PAH.
What does 'Phase I/II' mean?
It's an early stage of research. Phase I checks safety, and Phase II starts looking at effectiveness and dosage in a small group of patients.
Will I get the actual medicine or a placebo?
The study mentions it's 'randomised, double-blind, placebo-controlled', meaning some will get the medicine and some a dummy drug, and neither you nor the doctors will know which.
What is a right heart catheterisation (RHC)?
It's a procedure where a thin tube is inserted into a large vein to measure pressures in your heart and lungs, helping doctors understand your condition better.
Hur du får reda på mer
Sarah Hughes
Prata alltid med din läkare eller specialist innan du bestämmer dig för att delta i en studie.
Intresserad av att delta?
Diskussion
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