A Study Evaluating the Long-Term Efficacy and Safety of Ralinepag in Subjects With PAH Via an Open-Label Extension
This study, called ADVANCE EXTENSION, is designed for people with a specific type of lung condition called WHO Group 1 Pulmonary Arterial Hypertension (PAH). Participants must have already taken part in an earlier study looking at the drug Ralinepag. The main goal is to understand how well Ralinepag works and if it's safe over a longer period. Participants will continue to receive Ralinepag alongside any other PAH medications they are already taking. It's an "open-label" study, meaning everyone involved, including the participants and doctors, will know they are receiving Ralinepag. This research helps us learn more about the long-term use of this medication for PAH.
At a glance
What is this study about?
This study, known as ADVANCE EXTENSION, is a continuation for people who have already been involved in a study testing a drug called Ralinepag for a serious lung condition called Pulmonary Arterial Hypertension (PAH). PAH is a rare disease where the blood vessels in the lungs become narrow, making it difficult for the heart to pump blood through them. This can lead to symptoms like breathlessness and tiredness.
The main purpose of this study is to gather more information about the long-term effects of Ralinepag. Specifically, doctors want to see how well the drug continues to work over time to help manage PAH, and to track any side effects that might occur with long-term use. The study is "open-label," which means that everyone involved – the participants, the doctors, and the researchers – will know that Ralinepag is being given. This is different from a "blinded" study where some people might receive a placebo (a dummy pill).
If you join this study, you will continue to receive Ralinepag. This will be in addition to any other medicines you are already taking for your PAH. The information collected from this study is really important because it helps medical professionals understand how to best use Ralinepag to help people live better with PAH in the long run. The study will continue until the drug is approved and available more widely, or if the study needs to end for other reasons.
Key takeaways
- This study is for people with PAH who have previously taken Ralinepag.
- Its main aim is to understand the long-term safety and effectiveness of Ralinepag.
- Participants will know they are receiving Ralinepag (it's 'open-label').
- Ralinepag will be given alongside your usual PAH medications.
- Regular check-ups and tests will monitor your health and the drug's effects.
- You can leave the study at any time without affecting your normal care.
Who may be eligible?
To be considered for this study, you must have already taken part in a previous study involving the drug Ralinepag for your Pulmonary Arterial Hypertension (PAH). You also need to have successfully completed all the required steps of that earlier study.
It's important that you are willing and able to attend all scheduled appointments, follow the treatment plan, and have necessary tests done. If you are a man or woman who could become pregnant, you'll need to agree to use effective contraception throughout the study and for 30 days after taking your last dose of Ralinepag. This also means not trying to become pregnant or making someone pregnant during this time.
Unfortunately, you won't be able to join if you had to stop your previous Ralinepag study because of serious side effects or if you didn't finish all the necessary procedures in that study. You also cannot participate if you decided to stop your involvement in a previous Ralinepag study, are pregnant or breastfeeding, or have recently had a lung or heart/lung transplant since your last Ralinepag study.
- I have previously participated in a study involving Ralinepag for PAH.
- I completed all the required steps of that previous Ralinepag study.
- I am aged 18 years or older.
- I am willing to attend all study visits and undergo tests.
- If I can become pregnant or make someone pregnant, I agree to use contraception during the study.
- I have not had a lung or heart/lung transplant since my last Ralinepag study.
This is a guide only — the research team will confirm whether you can take part.
What does participation involve?
If you decide to take part in this study, you will receive the drug Ralinepag. You will continue to take Ralinepag along with any other medications you are already using for your PAH. If you're coming from a study where you didn't know if you were getting Ralinepag or a placebo, you might have a 16-week period where the dose is adjusted, but you'll still be receiving Ralinepag.
Throughout the study, you'll have regular hospital or clinic visits where you'll be checked by the doctors and nurses. These visits will involve various tests to monitor your health and how you're responding to the medication, such as blood tests or heart and lung assessments. The doctors will also keep track of any side effects you experience.
There's no set total duration for this extension study. You will continue to receive Ralinepag for as long as the study is ongoing, unless you or your doctor decide it's best for you to stop, or if Ralinepag becomes widely available in your area.
Potential risks and benefits
Locations (190)
- St. Joseph's Hospital and Medical Center-Norton Thoracic InstitutePhoenix, United States
- University of ArizonaTucson, United States
- UCSD Health SciencesLa Jolla, United States
- Ronald Reagan UCLA Medical CenterLos Angeles, United States
- Keck Hospital of USCLos Angeles, United States
- VA Greater Los Angeles Healthcare SystemLos Angeles, United States
- University of California, IrvineOrange, United States
- University of California Davis Medical CenterSacramento, United States
- Santa Barbara Cottage HospitalSanta Barbara, United States
- Stanford University Medical CenterStanford, United States
- University of Colorado HospitalAurora, United States
- National Jewish HealthDenver, United States
+178 more sites — see the official record for the full list.
Common questions
What is Pulmonary Arterial Hypertension (PAH)?
PAH is a serious condition where the blood vessels in your lungs become narrowed, making it harder for your heart to pump blood through them. This can cause symptoms like breathlessness and fatigue.
What is an 'open-label' study?
In an open-label study, both you and your doctor will know that you are receiving the study drug (Ralinepag). This is different from a 'blinded' study where you might not know if you're getting the drug or a dummy pill.
Will I take Ralinepag instead of my current PAH medicines?
No, you will continue to take Ralinepag in addition to your existing PAH medications. It's meant to work alongside what you're already taking.
What happens if Ralinepag becomes available outside the study?
If Ralinepag gets approved and becomes widely available where you live, the study may end for you, and your doctor can then prescribe it to you if appropriate.
Can I stop participating in the study at any time?
Yes, you are free to withdraw from the study at any point and for any reason, without it affecting your ongoing medical care.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
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