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

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ClinicalTrials.gov Identifier: NCT02252159
Recruitment Status : Completed
First Posted : September 30, 2014
Last Update Posted : April 26, 2021
Sponsor:
Information provided by (Responsible Party):
Incyte Corporation

Tracking Information
First Submitted Date September 23, 2014
First Posted Date September 30, 2014
Last Update Posted Date April 26, 2021
Actual Study Start Date July 31, 2014
Actual Primary Completion Date August 3, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: September 25, 2014)
  • Description of patterns of the disease Polycythemia Vera (PV), and associations of such patterns with patients' exposures or treatments [ Time Frame: Every 3 months for approximately 36 months ]
  • Incidence (frequency) of disease progression [ Time Frame: Every 3 months for approximately 36 months ]
  • Incidence (frequency) of healthcare resources utilization [ Time Frame: Every 3 months for approximately 36 months ]
    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).
  • Incidence (frequency) of complications due to PV [ Time Frame: Every 3 months for approximately 36 months ]
  • Incidence (frequency) and description of PV-related symptoms [ Time Frame: Every 3 months for approximately 36 months ]
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: September 25, 2014)
  • Incidence (frequency) of adverse events (for those patients on active therapies, including PHL) [ Time Frame: Baseline through end of study. Approximately 36 months ]
  • Patient-reported outcomes as assessed by Myeloproliferative Neoplasm Symptom Assessment Form Total Symptom Score (MPN-SAF TSS) for assessment of the severity of symptoms [ Time Frame: Every 3 months for approximately 36 months ]
    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.
  • Work Productivity and Activity Impairment Questionnaire - Specific Health Problem (WPAI-SHP) score for assessment of work productivity and activity impairment [ Time Frame: Every 3 months for approximately 36 months ]
    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.
  • European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC QLQ-C30) for Health Related Quality of Life (HRQoL) [ Time Frame: Every 3 months for approximately 36 months ]
  • Caregiver burden [ Time Frame: Every 3 months for approximately 36 months ]
    The amount of health care received by a paid healthcare worker or by an unpaid caregiver
  • Burden of phlebotomy (PHL) [ Time Frame: Every 3 months for approximately 36 months ]
    A patients self-reported assessment of burden including pain at site, difficulty and inconvenience of scheduling and cost factors.
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Prospective Observational Study Of Patients With Polycythemia Vera In US Clinical Practices (REVEAL)
Official Title Prospective, Non-interventional Study of Disease Progression and Treatment of Patients With Polycythemia Vera in United States Academic or Community Clinical Practices
Brief 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.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
Description:
Blood sample(s), two vials, one with heparin, another with ethylenediaminetetraacetic acid (EDTA) will be collected at enrollment and then annually thereafter until the end of study for serum analysis of proteins and assessment of allele burden and mutations.
Sampling Method Probability Sample
Study Population An adult population (patients >18 years old) of men and women who have been diagnosed with clinically overt PV will be enrolled. Sites will include both community and academic centers across the United States that are representative of where patients with PV are diagnosed and treated.
Condition MPN (Myeloproliferative Neoplasms)
Intervention Not Provided
Study Groups/Cohorts
  • Cohort A

    Patients with clinically overt PV (and not exhibiting any of the characteristics listed for Cohort B), managed with:

    1. Watchful waiting (with or without aspirin)*, or
    2. Phlebotomy (PHL) alone (with or without aspirin)* - or
    3. HU alone (without concomitant PHL, with or without aspirin).

    (*Unless patient has a history of intolerance or clinical resistance/ refractoriness to hydroxyurea [HU] (as assessed by the treating physician) - in which case, s/he belongs to Cohort B)

  • Cohort B

    Patients with clinically overt PV, with one or more of the following disease characteristics:

    1. Treatment with HU and PHL in combination or
    2. Treatment with any agent other than HU or aspirin (e.g., recombinant interferon (IFN) or pegylated IFN preparations, busulfan, anagrelide) or
    3. A history of thrombosis (venous or arterial) or
    4. A history of intolerance or clinical resistance/ refractoriness to HU (as assessed by the treating physician) or
    5. Presence of documented splenomegaly (clinically assessed by palpation) or
    6. Presence of one or more of the following uncontrolled symptoms related to PV despite therapy (Symptoms deemed uncontrolled as per physician's judgment)

      1. Tiredness
      2. Difficulty sleeping
      3. Itching
      4. Muscle aches and/or bone pain
      5. Night sweats
      6. Sweats while awake
      7. Other
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: August 16, 2016)
2544
Original Estimated Enrollment
 (submitted: September 25, 2014)
2000
Actual Study Completion Date August 3, 2019
Actual Primary Completion Date August 3, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria

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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Puerto Rico,   United States
Removed Location Countries Ukraine
 
Administrative Information
NCT Number NCT02252159
Other Study ID Numbers INCB-MA-PV-401
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Incyte Corporation
Study Sponsor Incyte Corporation
Collaborators Not Provided
Investigators
Study Director: Robyn M. Scherber, MD, MPH Incyte Corporation
PRS Account Incyte Corporation
Verification Date April 2021