Prospective, Non-interventional Study of Disease Progression and Treatment of Patients With Polycythemia Vera in United States Academic or Community Clinical Practices
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 2,544
- 主要终点
- Description of patterns of the disease Polycythemia Vera (PV), and associations of such patterns with patients' exposures or treatments
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Description of patterns of the disease Polycythemia Vera (PV), and associations of such patterns with patients' exposures or treatments
时间窗: Every 3 months for approximately 36 months
Incidence (frequency) and description of PV-related symptoms
时间窗: Every 3 months for approximately 36 months
Incidence (frequency) of disease progression
时间窗: Every 3 months for approximately 36 months
Incidence (frequency) of healthcare resources utilization
时间窗: 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
时间窗: Every 3 months for approximately 36 months
次要结局
- Incidence (frequency) of adverse events (for those patients on active therapies, including PHL)(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(Every 3 months for approximately 36 months)
- Burden of phlebotomy (PHL)(Every 3 months for approximately 36 months)
- 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)
- Caregiver burden(Every 3 months for approximately 36 months)
- Work Productivity and Activity Impairment Questionnaire - Specific Health Problem (WPAI-SHP) score for assessment of work productivity and activity impairment(Every 3 months for approximately 36 months)