Une étude clinique de Sotatercept (MK-7962) chez des personnes atteintes d'hypertension artérielle pulmonaire (MK-7962-031/EXTENSION LIGHTRAY)
This research study is investigating a new medication called sotatercept for people living with pulmonary arterial hypertension (PAH). PAH is a condition where blood pressure in the arteries leading to the lungs is too high. This particular study is an extension of an earlier study (MK-7962-024, also known as LIGHTRAY) that looked at how safe and effective sotatercept was. Now, researchers want to continue learning more about sotatercept, specifically when it's given in doses that are adjusted based on a person's weight group. The main goal is to understand if these weight-based doses are safe and well-tolerated by participants over a longer period.
En un coup d'œil
De quoi parle cette étude ?
Pulmonary arterial hypertension, often called PAH, is a serious condition where the blood vessels in your lungs become narrow, making it harder for your heart to pump blood through them. This can lead to symptoms like breathlessness and tiredness. Researchers are urgently looking for new and better ways to treat PAH to help people feel better and live longer.
This study is focusing on a new medicine called sotatercept. We know from earlier research that sotatercept shows promise in treating PAH. A previous study, called LIGHTRAY, already looked into how safe sotatercept was and how well it worked for people with PAH. That study also explored different ways of giving the medicine, either based on a person's exact weight or using doses that fit within certain weight ranges.
This new study, called LIGHTRAY EXTENSION, is for people who took part in the original LIGHTRAY study. It's a chance for them to continue receiving sotatercept. The main aim here is to understand if giving sotatercept in doses based on weight groups (rather than exact weight) is safe and if people can continue taking it over a longer period without significant problems. This helps doctors understand the long-term effects and how best to give the medicine if it becomes widely available.
Points clés
- This study is for people previously in the LIGHTRAY study for PAH.
- It aims to learn more about the long-term safety of sotatercept.
- Sotatercept doses will be based on weight groups (weight-banded).
- It's a research study, not standard treatment.
- All participants will continue to receive sotatercept.
Qui peut être éligible ?
To join this particular study, you must have already taken part in the previous LIGHTRAY study (MK-7962-024) and completed the treatment period there. You should not have stopped taking the study medicine in that previous study and must be considered safe to continue in this extension study.
It's also important that you haven't started taking sotatercept that is bought from a chemist or prescribed normally, as this study is still part of the research process. You also shouldn't be taking any other similar medicines that work in the same way as sotatercept.
Anyone aged 18 years and older, male or female, who meets these criteria may be able to join. Your study doctor will check all these points to see if this study is suitable for you.
Cet étude pourrait-elle vous convenir ?
Répondez à ces questions rapides pour voir si vous êtes éligible. Ceci est un guide uniquement — l'équipe de recherche prend la décision finale.
- Did you complete the previous LIGHTRAY study (MK-7962-024)?
- Did you stay on the study treatment throughout that previous study?
- Are you currently not taking commercially available sotatercept?
- Are you not taking any other similar activin signalling inhibitor medicines?
En quoi consiste la participation ?
If you join this study, you will continue to receive the study medicine, sotatercept, which will be given in doses based on your weight group. You will also continue with any other PAH treatments your doctor has prescribed, as sotatercept is meant to be an add-on treatment. You will have regular visits to the clinic so the study team can monitor your health, check for any side effects, and make sure the treatment is working well. These visits will involve various checks, including physical exams, blood tests, and possibly other tests related to your heart and lung health. The study aims to follow participants for a longer time to understand the long-term safety of sotatercept when given using a weight-based dosing plan. The specific number and frequency of visits, and the total duration you'll be in the study, will be fully explained by the study team.
Risques et avantages potentiels
Locations (73)
- University of Colorado Anschutz Medical Campus-University of Colorado Hospital Cardiac and Vascular ( Site 1930)Code postal vérifiéAurora, États-Unis
- University of Kansas Medical Center ( Site 1928)Code postal vérifiéKansas City, États-Unis
- University of New Mexico Health Sciences Center - Department of Internal Medicine ( Site 1916)Code postal vérifiéAlbuquerque, United States
- Centro Medico Capital ( Site 0002)Code postal vérifiéLa Plata, Argentina
- Instituto de Investigaciones Clinicas Mar del Plata ( Site 0006)Code postal vérifiéMar del Plata, Argentina
- Instituto Medico Rio Cuarto ( Site 0010)Code postal vérifiéRío Cuarto, Argentina
- Instituto de Cardiologia Juana F. Cabral ( Site 0008)Code postal vérifiéCorrientes, Argentina
- Hospital Provincial Jose Maria Cullen ( Site 0005)Code postal vérifiéSanta Fe, Argentina
- Royal Prince Alfred Hospital ( Site 0103)Code postal vérifiéCamperdown, Australia
- Westmead Hospital ( Site 0100)Code postal vérifiéWestmead, Australia
- Wesley Research Institute ( Site 0101)Code postal vérifiéAuchenflower, Australia
- The Alfred Hospital ( Site 0102)Code postal vérifiéMelbourne, Australie
Questions fréquentes
What is pulmonary arterial hypertension (PAH)?
PAH is a serious condition where blood pressure in the arteries leading to the lungs becomes too high, making it hard for the heart to pump blood.
What is sotatercept?
Sotatercept is a new medicine being studied as a treatment for PAH. It's not yet available as a standard treatment.
Why is this an 'extension' study?
It's for people who were already in a previous study looking at sotatercept for PAH. It allows them to keep taking the medicine and helps researchers gather more long-term information.
Qui peut participer à cette étude ?
Only people who finished the previous LIGHTRAY study safely and without stopping the study medicine are eligible for this extension study.
Are there different doses of sotatercept?
Yes, in this study, sotatercept will be given in doses that are adjusted based on a person's weight group.
Comment en savoir plus
Parlez toujours à votre médecin généraliste ou spécialiste avant de décider de participer à une étude.
Discussion
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