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
NCT number | NCT02252159 |
Other study ID # | INCB-MA-PV-401 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | July 31, 2014 |
Est. completion date | August 3, 2019 |
Verified date | April 2021 |
Source | Incyte Corporation |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
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 |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Incyte Corporation |
United States, Puerto Rico,
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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