An Open Label Extension (OLE) Study to Evaluate Long-term Safety and Tolerability of Pelacarsen (TQJ230)
This study is about a new medicine called pelacarsen, which is being tested for a condition called hyperlipoproteinemia(a). This condition means you have too much of a certain type of fat in your blood, which can increase your risk of heart problems. This is an "open-label extension" study, which means participants know they are receiving the pelacarsen medicine, and it's a follow-on from an earlier study. It aims to check the long-term safety and how well participants tolerate the medicine over approximately five years. It's open to people in Germany aged 18 to 100 who have completed the initial study and have existing heart and blood vessel disease. The goal is to gather more information about this new treatment over time.
At a glance
What is this study about?
This study is looking at a new medicine called pelacarsen. It's for people who have a condition called hyperlipoproteinemia(a), often shortened to Lp(a). This means you have higher than normal levels of a specific type of fat in your blood. High Lp(a) can increase your risk of developing heart and blood vessel problems. Pelacarsen is designed to help lower these high levels.
This particular study is a follow-on, or "extension," from a previous study. This means that people who have already taken part in the earlier research into pelacarsen and have certain heart conditions are being invited to continue receiving the medicine. The main aim of this follow-on study is to understand how safe pelacarsen is when taken for a long time, up to five years, and whether people tolerate it well.
Because this is an "open-label" study, everyone taking part will know they are receiving pelacarsen. This is different from the previous study where some people might have received a dummy treatment. By closely watching people over a longer period, researchers can get a much better idea of how the medicine works in the real world and ensure it's safe for patients.
Key takeaways
- The study helps understand the long-term safety of pelacarsen.
- It's a follow-on study for people who already took part in earlier research.
- Pelacarsen is a new medicine for high lipoprotein(a) and heart disease.
- Participation involves taking the medicine and regular health check-ups.
- The study will last for about five years.
- You can withdraw from the study at any time.
Who may be eligible?
To take part in this study, you must have already completed the previous study involving pelacarsen and the research team must agree that it's safe for you to continue. You need to be willing to sign a consent form that shows you understand what the study involves and agree to take part.
There are also some reasons why you wouldn't be able to join. If you have any health conditions that the study doctor thinks could put you at risk by participating, you wouldn't be able to take part. This is to ensure your safety throughout the study.
Pregnant or breastfeeding women cannot join. Also, women who could become pregnant must be using reliable birth control methods during the study and for about 16 weeks after stopping the medication. This is to prevent any potential risks to an unborn baby.
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.
- Have I already completed the main pelacarsen study?
- Do I currently have heart or blood vessel disease?
- Am I aged between 18 and 100 years old?
- Am I living in Germany?
- If I am a woman who could become pregnant, am I using effective birth control?
- Am I able to commit to follow-up appointments for about five years?
What does participation involve?
If you decide to take part, you will be given the pelacarsen medicine. Everyone in this study will know they are receiving the active medicine. The study will involve regular check-ups with the study team at a clinic in Germany. These visits will likely include blood tests, health assessments, and discussions about how you're feeling and whether you're having any side effects. This is to monitor your health and how you're responding to the treatment. The study is planned to last for approximately five years, so it's a long-term commitment. You will be closely supported by the medical team throughout this period.
Potential risks and benefits
Locations (9)
- Novartis Investigative SiteVerified postcodeFrankfurt am Main, Germany
- Novartis Investigative SiteVerified postcodeBerlin, Germany
- Novartis Investigative SiteVerified postcodeCloppenburg, Germany
- Novartis Investigative SiteVerified postcodeDresden, Germany
- Novartis Investigative SiteVerified postcodeErlangen, Germany
- Novartis Investigative SiteVerified postcodeMainz, Germany
- Novartis Investigative SiteVerified postcodeMünchen, Germany
- Novartis Investigative SiteVerified postcodeUlm, Germany
- Novartis Investigative SiteVerified postcodeWürzburg, Germany
Common questions
What is hyperlipoproteinemia(a)?
It's a condition where you have high levels of a specific type of fat in your blood, which can increase your risk of heart problems.
What is an 'open-label' study?
An 'open-label' study means that everyone involved, including you and the study team, knows you are receiving the active medicine, pelacarsen.
How long will I be in this study?
If you join, you will be in the study for approximately five years.
Who can participate in this study?
This study is for people who have already finished the main pelacarsen study, live in Germany, are aged 18-100, and have existing heart and blood vessel disease.
Can I stop participating if I want to?
Yes, you can choose to leave the study at any time, for any reason, and it won't affect your future medical care.
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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