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

Completed

Conditions studied: MPN (Myeloproliferative Neoplasms)

In brief

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.

Key facts

Study ID

NCT02252159

Run by

Incyte Corporation

People needed

2544

Starts

2014-07-31

Expected to finish

2019-08-03

Last updated by the study team

2021-04-26

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Study site — Safford, Arizona, United States
• Study site — Scottsdale, Arizona, United States
• Study site — Tucson, Arizona, United States
• Study site — Yuma, Arizona, United States
• Study site — Jonesboro, Arkansas, United States
• Study site — Little Rock, Arkansas, United States
• Study site — North Little Rock, Arkansas, United States
• Study site — Stuttgart, Arkansas, United States
• Study site — Berkeley, California, United States
• Study site — Burbank, California, United States
• Study site — Corona, California, United States
• Study site — Fountain Valley, California, United States
• Study site — Highland, California, United States
• Study site — Laguna Hills, California, United States
• Study site — Los Alamitos, California, United States
• Study site — Oceanside, California, United States
• Study site — Orange, California, United States
• Study site — Pismo Beach, California, United States
• Study site — Rancho Mirage, California, United States
• Study site — Riverside, California, United States
• Study site — Santa Maria, California, United States
• Study site — Santa Rosa, California, United States
• Study site — Tarzana, California, United States
• Study site — Torrance, California, United States
• Study site — Green Valley, Arizona, United States

Full record on ClinicalTrials.gov

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