INTREPID: A Study of Sapablursen Evaluating the Safety and Efficacy in Participants With Polycythemia Vera (PV)
This clinical trial, called INTREPID, is investigating a new medicine named sapablursen for people living with Polycythemia Vera (PV). PV is a blood condition where the body makes too many red blood cells. The main goal is to find out if sapablursen is safe and effective when used alongside the treatments people already receive for PV. Some participants will get sapablursen, while others will receive a placebo (a dummy medicine). The study is divided into different stages, and people could be involved for up to 156 weeks (about three years). By studying sapablursen, researchers hope to find new ways to help manage PV.
Överblick
Vad handlar denna studie om?
Polycythemia Vera (PV) is a long-term blood condition where your body makes too many red blood cells. This can make your blood thicker, increasing the risk of problems like blood clots. People with PV often need regular treatment to manage their condition, which might include having blood removed (phlebotomy) or taking medicines to reduce blood cell production.
This study is looking at a new investigational medicine called sapablursen. It's being tested to see if it can help improve the treatment for people with PV. The researchers want to know if adding sapablursen to the standard treatments people already receive is both safe and effective. They are particularly interested in whether it can help control the number of red blood cells and reduce the need for phlebotomy.
The INTREPID study is a 'Phase 3' trial, which means it's one of the final steps before a new medicine might become widely available. It will involve a large number of participants to thoroughly check the benefits and any potential side effects of sapablursen. The study compares sapablursen to a 'placebo' (a dummy medicine that looks the same but contains no active drug) to see if sapablursen makes a real difference. This is a common and important way to test new medicines fairly.
Viktiga punkter
- This study is testing a new medicine, sapablursen, for Polycythemia Vera (PV).
- It aims to see if sapablursen is safe and effective when added to current PV treatments.
- Participation could last up to three years, involving regular clinic visits and tests.
- Some participants will receive the new medicine, others a dummy pill (placebo), initially.
- This is a 'Phase 3' study, meaning it's a key step in developing new treatments for PV.
Vem kan vara berättigad?
To join this study, you must have a confirmed diagnosis of Polycythemia Vera (PV) based on the latest medical guidelines. Your PV should be at a point where you need to have blood removed regularly (phlebotomy) to keep your red blood cell count at a healthy level (below 45%). If you're already taking other medicines to lower your blood cell count, you need to be on a stable dose of that medicine before starting the study.
There are also some reasons why you might not be able to join. For example, if you've recently had a serious blood clot (like a heart attack or stroke) within the last month, or if you've already been treated with certain other experimental PV medicines. You also can't join if your PV has progressed to a more advanced condition called post-PV myelofibrosis, or if you have any other serious medical conditions that would make it unsafe or difficult to take part in the study.
Participants must be at least 18 years old. Both men and women are welcome to take part in the study.
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.
- Have I been diagnosed with Polycythemia Vera (PV) by a doctor?
- Do I need regular blood removal (phlebotomy) for my PV?
- Is my red blood cell count (Haematocrit) below 45% at the moment?
- If I take other PV medicines, have I been on a stable dose for a while?
- Have I had a serious blood clot (like a heart attack or stroke) in the last month?
- Has my PV progressed to a condition called post-PV myelofibrosis?
Vad innebär deltagande?
If you decide to take part in the INTREPID study, it will involve several stages over a maximum of about three years (156 weeks). For the first part of the study, you won't know if you're receiving sapablursen or a dummy medicine (placebo); this is called a 'blinded' study. Later on, everyone will receive sapablursen openly.
During your time in the study, you will have regular visits to the clinic for check-ups, blood tests, and other assessments to monitor your health and how the treatment is working. You will receive either the study medicine or placebo, and your regular PV treatments will continue as usual. All study-related medicines and tests will be provided free of charge. Your commitment involves following the study schedule, taking the medication as instructed, and reporting any changes in your health to the study team.
Potentiella risker och fördelar
Platser (38)
- UC Irvine Health - Chao Family Comprehensive Cancer CenterVerifierat postnummerOrange, USA· Rekrytering
- Regis Clinical Research LLC.Verifierat postnummerMiami, USA· Rekrytering
- Florida Clinical Trials GroupVerifierat postnummerPlantation, USA· Rekrytering
- Florida Clinical Trials GroupVerifierat postnummerTamarac, United States· Rekrytering
- Central Georgia Cancer CareVerifierat postnummerMacon, USA· Rekrytering
- The Center for Cancer & Blood DisordersVerifierat postnummerBethesda, USA· Rekrytering
- The Cancer and Hematology CentersVerifierat postnummerGrand Rapids, USA· Rekrytering
- Montefiore medicinska centrumVerifierat postnummerThe Bronx, USA· Rekrytering
- Gabrail Cancer Center ResearchVerifierat postnummerCanton, United States· Rekrytering
- The James Cancer Hospital and Solove Research Institute at The Ohio State UniversityVerifierat postnummerColumbus, USA· Rekrytering
- Fox Chase Cancer CenterVerifierat postnummerPhiladelphia, USA· Rekrytering
- University of Texas M.D. Anderson Cancer CenterVerifierat postnummerHouston, USA· Rekrytering
Vanliga frågor
What is Polycythemia Vera (PV)?
PV is a rare blood condition where your body makes too many red blood cells, which can make your blood thicker.
What is sapablursen?
Sapablursen is a new medicine being tested in this study to see if it can help manage Polycythemia Vera.
What does 'Phase 3' mean for a study?
Phase 3 means this is one of the final and largest stages of testing a new medicine, involving many people to check its safety and effectiveness before it might become widely available.
Will I know if I'm getting the new medicine or a dummy pill?
For the first part of the study, you won't know if you're receiving sapablursen or a dummy pill (placebo). This helps ensure fair results.
Hur länge skulle jag vara med i studien?
You could be involved in the study for up to about three years (156 weeks) depending on the stage of the study you participate in.
Hur du får reda på mer
Clinical Team
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