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

MPN (Myeloproliferative Neoplasms) Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02252159
• Other study ID #: INCB-MA-PV-401
• Status: Completed
• Start date: July 31, 2014
• Est. completion date: August 3, 2019

Study information

• Verified date: April 2021
• Source: Incyte Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2544
• Est. completion date: August 3, 2019
• Est. primary completion date: August 3, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• MPN (Myeloproliferative Neoplasms)
• Myeloproliferative Disorders
• Polycythemia
• Polycythemia Vera

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Incyte Corporation

Countries where clinical trial is conducted

United States,  Puerto Rico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Description of patterns of the disease Polycythemia Vera (PV), and associations of such patterns with patients' exposures or treatments		Every 3 months for approximately 36 months
Primary	Incidence (frequency) of disease progression		Every 3 months for approximately 36 months
Primary	Incidence (frequency) of healthcare resources utilization	Healthcare resources were defined as a. Medical visits (including Office visits, ER visits, and hospitalizations), b. phlebotomy (PHL) procedures and c. prescriptions (including PV-related prescriptions, PV-related over-the-counter (OTC) medications, and prescription medications for co-morbid conditions).	Every 3 months for approximately 36 months
Primary	Incidence (frequency) of complications due to PV		Every 3 months for approximately 36 months
Primary	Incidence (frequency) and description of PV-related symptoms		Every 3 months for approximately 36 months
Secondary	Incidence (frequency) of adverse events (for those patients on active therapies, including PHL)		Baseline through end of study. Approximately 36 months
Secondary	Patient-reported outcomes as assessed by Myeloproliferative Neoplasm Symptom Assessment Form Total Symptom Score (MPN-SAF TSS) for assessment of the severity of symptoms	The MPN-SAF TSS is a validated 10-item instrument that efficiently assesses the prevalence and severity of PV symptoms in both clinical practice and trial settings. Higher scores indicate more severe symptoms and greater inactivity with a possible total score range of 0-100.	Every 3 months for approximately 36 months
Secondary	Work Productivity and Activity Impairment Questionnaire - Specific Health Problem (WPAI-SHP) score for assessment of work productivity and activity impairment	WPAI-SHP is a validated 6-item instrument that measures the effect of overall health and specific symptoms on productivity at work and outside of it. All outcomes are presented as a proportion, with 0% representing minimal/no impairment and 100% representing maximal impairment or productivity loss.	Every 3 months for approximately 36 months
Secondary	European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC QLQ-C30) for Health Related Quality of Life (HRQoL)		Every 3 months for approximately 36 months
Secondary	Caregiver burden	The amount of health care received by a paid healthcare worker or by an unpaid caregiver	Every 3 months for approximately 36 months
Secondary	Burden of phlebotomy (PHL)	A patients self-reported assessment of burden including pain at site, difficulty and inconvenience of scheduling and cost factors.	Every 3 months for approximately 36 months

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