You may be eligible to join ECLIPSE PV, a Phase 3b clinical research study in the US and Canada that is evaluating a new dosing regimen compared to the current recommended dosing regimen of an approved PV therapy. This therapy helps patients control increased blood counts (the number of red blood cells, white blood cells, and platelets) in the body more quickly.
Polycythemia vera (PV) is a rare blood cancer characterized by a genetic mutation that leads to an excessive increase in blood counts (the number of red blood cells, white blood cells, and platelets) produced in the body. This increase in blood counts causes the blood to thicken, which can lead to blood clots, blockage of blood flow through arteries and veins, and possible vascular complications. Some people with PV have no symptoms while others can develop many health problems due to additional blood counts in the body. PV may progress to other conditions, such as myelofibrosis and leukemia.
Symptoms of PV can include the following:
Although rare, PV can also cause more serious problems, including stroke and heart attack because of the increased risk of blood clots.
The goal of treatments for PV is to control blood counts (the number of red blood cells, white blood cells, and platelets) in the body to help reduce the symptoms and potential health risks associated with the disease. This can be done through a procedure called a phlebotomy, in which blood is drawn from a vein to reduce the amount of blood in the body.
Researchers continue to conduct clinical studies to better understand PV and how best to treat it.
Patient participation in clinical research studies is important in helping us learn more about potential new treatments for the community.
The ECLIPSE PV study is for adults who have been diagnosed with PV and are not refractory or intolerant to interferon therapy.
The purpose of this study is to assess the effectiveness and safety of two dosing regimens of ropeginterferon alfa-2b-njft (an accelerated titrated dosing versus the current recommended dosing) in adult patients with PV.
The main study will last approximately 7 months, including a screening period and a core study period. After completion of the core study period, study participants will continue on to an extension period of the study. This portion of the study will allow investigators to evaluate the effectiveness and safety of ropeginterferon alfa-2b-njft in the long term.
Did your doctor diagnose your PV because of elevated red blood cells, genetic testing (JAK2 V617F), and bone marrow biopsy/evaluation?
Have you had any prior interferon therapy and had to stop treatment?
Do you have any contraindications or hypersensitivity to treatment with an interferon?
18 years of age or older
Diagnosed with PV according to select criteria, including elevated red blood cell count, the presence of a genetic mutation (JAK2 V617F), and a bone marrow biopsy
Not refractory or intolerant to interferon therapy
Study participants will need to meet additional eligibility criteria to be accepted to enroll in the study.
If you agree to participate in the clinical study, you will visit the study clinic and undergo a series of assessments to find out if you meet all the study requirements before beginning participation. If you meet all the requirements, you can then begin the study treatment period. Once you have completed the main study treatment period (approximately 6 months), you may continue on treatment with the study drug during an extension portion of the study.
The length of time for which you receive treatment will vary depending on how you respond to the study drug.
For more information about the ECLIPSE PV clinical study, please visit ClinicalTrials.gov (trial identifier: NCT05481151).