Do you have polycythemia vera (PV)?
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.
What is PV?
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:
Trouble concentrating
Night sweats
Fatigue and inactivity
Itching
Abdominal discomfort
Feeling full quickly when you eat
Bone painAlthough 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.
Why take part in a clinical research study?
Patient participation in clinical research studies is important in helping us learn more about potential new treatments for the community.
Clinical research studies explore whether a therapy, device, or test is safe and improves people’s health- Before any therapy is approved and made available to the public, it goes through several phases of clinical research
- Every country where studies take place has strict rules about how clinical research is conducted
- Patient participation in any study is voluntary. Patients may leave a study at any time without penalty
Study details
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.
Ropeginterferon alfa-2b-njft
- Type of interferon alfa
- Currently approved by the FDA for adults with PV using a specific dosing regimen
- Administered as an injection under the skin every 2 weeks
Ropeginterferon alfa-2b-njft
- Type of interferon alfa
- Currently approved by the FDA for adults with PV using a specific dosing regimen
- Administered as an injection under the skin every 2 weeks
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.
Who can take part?
Question 1 of 3
Did your doctor diagnose your PV because of elevated red blood cells, genetic testing (JAK2 V617F), and bone marrow biopsy/evaluation?
Yes
No
Question 2 of 3
Have you had any prior interferon therapy and had to stop treatment?
Yes
No
Question 3 of 3
Do you have any contraindications or hypersensitivity to treatment with an interferon?
Yes
No
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.
What to expect
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.
4 weeks
Screening period
- Attend screening visits and provide a medical history
- Undergo assessments and evaluations to determine if you meet the study requirements to participate in ECLIPSE PV
6 months*
Core study period
- Receive ropeginterferon alfa-2b-njft every 2 weeks. Depending on which dosing group you are in, you will either receive a gradual dosing regimen or an accelerated dosing regimen
- If you are taking hydroxyurea for your PV at the time of enrollment in the study, the dose will be gradually decreased over several weeks until it is stopped completely
- Attend study visits to monitor your health and how you are responding to treatment. Some of these may be phone visits
6 months*
Extension study period
- Continue to receive ropeginterferon alfa-2b-njft every 2 weeks
- Attend study visits to monitor your health and how you are responding to treatment. Some of these may be phone visits
4 weeks
Study follow-up
- Attend the final study visit to monitor your health and how you responded to treatment
*
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).
Where are the clinical study sites in the US and Canada?
Find out if there’s a study site in your area using the table below. For additional information, please contact us by emailing clinicaltrials@pharmaessentia-us.com or call 1-800-999-2449.
- St. Paul's Hospital
- Vancouver, BC
- Juravinski Cancer Centre
- Hamilton, ON
- Princess Margaret Hospital
- Toronto, ON
- John Theurer Cancer Center at Hackensack UMC
- Hackensack, NJ
- Mount Sinai Medical Center
- New York City, NY
- Fox Chase Cancer Center
- Philadelphia, PA
- American Oncology Partners of Maryland PA (Center for Cancer & Blood Disorders)
- Bethesda, MD
- MD Anderson Cancer Center
- Houston, TX
- University of Virginia - Emily Couric Cancer Center
- Charlottesville, VA
- University of Utah
- Salt Lake City, UT
- University of Michigan
- Ann Arbor, MI
- Washington University School of Medicine - Division of Oncology
- St. Louis, MO
How can I enroll in ECLIPSE PV?
Discuss with your doctor
If you think you may be eligible to enroll in ECLIPSE PV, print this page or email it to your doctor and discuss it at your next visit.
Questions?
For more information, contact our Medical Information team at medinfo@pharmaessentia-us.com.
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