A Phase 2a, Randomized, Open-Label Study to Evaluate the Efficacy, Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of ISIS 702843 Administered to Patients with Phlebotomy Dependent Polycythemia Vera (PD-PV)
This study is for people with a blood condition called polycythemia vera, where their body makes too many red blood cells. Often, people with this condition need to have blood removed frequently, a procedure called phlebotomy, to keep their red blood cell count at a healthy level. Researchers are testing a new medicine called ISIS 702843 to see if it can help reduce how often people need to have this procedure. They also want to understand if the medicine is safe, what side effects it might cause, and how it works in the body. The main goal is to find out if the medicine can significantly lower the number of times a person needs to have blood removed over a 37-week period.
A colpo d'occhio
Di cosa tratta questo studio?
This research study is focused on a health problem called polycythemia vera (PV). With PV, your body makes too many red blood cells, which can make your blood thicker than it should be. To manage this, many people with PV need to have blood regularly taken out of their arm, similar to donating blood. This procedure is called phlebotomy, and it helps keep the number of red blood cells in your blood at a safe level. This study is testing a new medicine, known as ISIS 702843, to see if it can help reduce how often people with PV need this blood removal.
The main aim of the study is to find out if taking ISIS 702843 means people need fewer phlebotomies over a specific period. They'll compare how many times people needed blood removed before starting the medicine to how many times they need it during the last 20 weeks of the 37-week treatment period. The researchers are also keen to learn more about how the medicine affects symptoms of PV, such as fatigue or itching, and to check its safety and how well people tolerate it.
By taking part, you could help doctors understand if ISIS 702843 is a good option for managing polycythemia vera. This kind of research is really important because it helps develop new and better ways to treat conditions and improve the lives of patients in the future.
Punti chiave
- This study is testing a new medicine for polycythemia vera (PV).
- It aims to see if the medicine can reduce the need for regular blood removal (phlebotomy).
- The study also assesses the safety and side effects of the new medicine.
- Participation involves regular clinic visits, blood tests, and symptom checks.
- Adults with PV who need regular phlebotomy may be suitable for the study.
Chi può essere idoneo?
To join this study, you need to be an adult, 18 years of age or older. Both men and women are welcome to take part.
Specifically, the study is looking for people who have been diagnosed with polycythemia vera (PV) and who currently need regular blood removal (phlebotomy) to manage their condition. This means your doctor has been removing blood from you because your red blood cell count is too high.
There might be other health requirements or conditions that could prevent someone from joining, which would be discussed in detail by the study team. It's always best to talk to the research team directly to see if this study is right for you.
Questo studio potrebbe fare al caso tuo?
Rispondi a queste domande rapide per vedere se potresti essere idoneo. Questo è solo una guida — il team di ricerca prende la decisione finale.
- Hai 18 anni o più?
- Do you have a diagnosis of polycythemia vera?
- Do you currently need to have blood removed regularly (phlebotomy) to manage your condition?
- Are you able to attend regular clinic visits for the study?
Cosa comporta la partecipazione?
If you join this study, you will receive the new medicine, ISIS 702843. This is an 'open-label' study, which means both you and the study doctors will know you are receiving the active medicine. The study will last for at least 37 weeks, and possibly longer if you continue into an extension period.
Throughout the study, you will have regular visits to the clinic for various checks. These visits will involve blood tests to see how the medicine is affecting your red blood cell count, as well as to check for any side effects and how the medicine is working in your body. They'll also monitor your vital signs, like blood pressure, and perform other routine medical checks like urine tests and possibly an ECG (heart test).
Doctors will carefully track how often you need phlebotomy. You will also be asked to complete questionnaires about your symptoms to see if the medicine is improving how you feel. Some blood tests will be taken at specific times after you take the medicine to understand how your body processes it.
Rischi e benefici potenziali
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Domande comuni
What is phlebotomy?
Phlebotomy is a procedure where a small amount of blood is taken from your body, similar to donating blood, to reduce the number of red blood cells in your system.
What is polycythemia vera (PV)?
Polycythemia vera is a condition where your body makes too many red blood cells, making your blood thicker and increasing the risk of blood clots.
Is ISIS 702843 a new medicine?
Yes, ISIS 702843 is a new medicine being tested in this study to see how well it works for polycythemia vera.
Riceverò sicuramente il nuovo medicinale?
Yes, this study is 'open-label,' meaning all participants will receive the new medicine, ISIS 702843.
Per quanto tempo sarò nello studio?
The main treatment period for the study is 37 weeks, but there might be an option to continue for longer in an extension period.
Come saperne di più
Parla sempre con il tuo medico di base o specialista prima di decidere di partecipare a uno studio.
Interessato a partecipare?
Discussione
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