Prospective Observational Study Of Patients With Polycythemia Vera In US Clinical Practices (REVEAL)



Status:Active, not recruiting
Conditions:Cancer, Hematology
Therapuetic Areas:Hematology, Oncology
Healthy:No
Age Range:18 - Any
Updated:2/3/2019
Start Date:July 2014
End Date:October 2019

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Prospective, Non-interventional Study of Disease Progression and Treatment of Patients With Polycythemia Vera in United States Academic or Community Clinical Practices

This is a Phase IV, multicenter, non-interventional, non-randomized, prospective,
observational study in an adult population (patients >18 years old) of men and women who have
been diagnosed with clinically overt PV and are being followed in either community or
academic medical centers in the United States who will be enrolled over a 12-month period and
observed for 36 months from the date the last patient is enrolled.


Inclusion Criteria:

- Age ≥18 years

- Diagnosis of Polycythemia Vera (PV)

- Willing and able to provide written informed consent

- Willing and able to complete patient assessment questionnaires either alone or with
minimal assistance from a caregiver and/or trained site personnel

- Under the supervision of a physician for the current care of PV including but not
limited to watchful waiting, acetylsalicylic acid (ASA) 81mg or greater,
antithrombotic therapy, Phlebotomy (PHL), Hydroxyurea (HU), interferon (recombinant or
pegylated), busulfan, anagrelide

Exclusion Criteria:

- Participation in an active clinical trial in which the study treatment is blinded

- Life expectancy <6 months

- Diagnosis of myelofibrosis (MF) [including primary MF, post-PV MF, or post-essential
thrombocythemia MF (post-ET MF)]

- Diagnosis of secondary Acute Myeloid Leukemia (AML)

- Diagnosis of Myelodysplastic Syndrome (MDS)

- History of or active plan to proceed to allogeneic hematopoietic stem cell transplant
in next 3 months

- Splenectomy
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