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

Incyte Corporation2,544 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

2,544

Conditions

MPN (Myeloproliferative Neoplasms)

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (266)

Outcomes

Primary Outcomes

Description of patterns of the disease Polycythemia Vera (PV), and associations of such patterns with patients' exposures or treatments