A Patient-Driven Registry for Exocrine Pancreatic Insufficiency Due to Chronic Pancreatitis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 400
- 试验地点
- 1
- 主要终点
- Progression Data (Every 6 months after Initial Visit)
研究概览
简要总结
The main objective of this study is to generate real-world evidence reflecting the experience of individuals with exocrine pancreatic insufficiency (EPI) due to chronic pancreatitis (CP). Efforts will be directed toward understanding the unmet need and therapeutic burden to identify the most critical factors that influence treatment choices/prescribing patterns, quality of life, and healthcare utilization outcomes in standard of care for individuals with EPI due to CP.
详细描述
Study participants will be followed prospectively, and data from study participants will be collected at 3-month intervals via Electronic Data Capture (EDC) portal. Investigators will complete assessments approximately every 6 months at the time of routine clinical encounters. Adverse Events (AEs) will be collected as part of the study data collection forms. Serious Adverse Events (SAEs) are to be reported within 24 hours (1 business day) of awareness, whether or not the site learns of the event at the time of a registry follow-up visit.
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
- •To be eligible for enrollment, a study participant must meet the inclusion criteria below:
- •At least 18 years of age (or age of majority)
- •Willing to provide consent to participate
- •Meet one (1) of the following at the time of enrollment:
- •Diagnosis of chronic pancreatitis (CP)
- •Diagnosis of recurrent acute pancreatitis (RAP)
- •Suspected or confirmed diagnosis of EPI made by a healthcare provider
- •On Pancreatic Enzyme Replacement Therapy (PERT), either prior to the Enrollment Visit or newly prescribed at the time of the Enrollment Visit.
- •To be eligible for enrollment into the registry, a study participant must not have any of the criteria below:
- •Currently participating in or planning to participate in a double-blind randomized trial and/or open-label Phase 3b/4 on CP or EPI
- •Diagnosed with any of the following conditions at the time of enrollment:
- •Cystic fibrosis
- •Fibrosing colonopathy
- •A history of or current diagnosis of pancreatic cancer, main duct papillary mucinous neoplasms (IPMNs), and other pancreatic malignancies
- •Allergy to pork or other porcine pancreatic enzyme products (PEPs)
- •Any condition that would, in the investigator's opinion, limit the individual's ability to complete the study.
排除标准
- 未提供
结局指标
主要结局
Progression Data (Every 6 months after Initial Visit)
时间窗: Every 6 months after Initial Visit up to 5 years
Collect clinical data to characterize EPI due to CP disease progression every 6 months after the initial visit alongside the physician at the site.
Treatment Compliance Data at Initial Visit
时间窗: At Initial Visit
Collect data on treatment compliance that may impact the EPI due to CP disease experience and/or outcome at the initial visit.
Baseline Data
时间窗: At Initial Visit
Collect baseline data of participants with EPI due to CP at the initial visit.
Impact and Burden of EPI due to CP Data at Initial Visit
时间窗: At Initial Visit
Gather data on healthcare utilization to be combined with clinical data to generate evidence for the impact and burden of EPI due to CP in this cohort on the healthcare system at the initial visit.
Disease History and Progression Data at Initial Visit
时间窗: At Initial Visit
Collect clinical data to characterize both the EPI due to CP disease history and disease progression at the initial visit.
Clinical Care Practice Data at Initial Visit
时间窗: At Initial Visit
Collect data on clinical care practices for participants with EPI to better understand the impact on outcomes at the initial visit.
Clinical Care Practice Data (Every 3 months after Initial Visit)
时间窗: Every 3 months after Initial Visit up to 5 years
Collect data on clinical care practices for participants with EPI to better understand the impact on outcomes every 3 months after the initial visit through a patient reported outcome (PRO).
Main Objective of the Study
时间窗: Up to 5 years
The main objective of this study is real-world evidence reflecting the experience of individuals with exocrine pancreatic insufficiency (EPI) due to chronic pancreatitis (CP).
Progression Data (Every 3 months after Initial Visit)
时间窗: Every 3 months after Initial Visit up to 5 years
Collect clinical data to characterize EPI due to CP disease progression every 3 months after the initial visit through a patient reported outcome (PRO).
Clinical Care Practice Data (Every 6 months after Initial Visit)
时间窗: Every 6 months after Initial Visit up to 5 years
Collect data on clinical care practices for participants with EPI to better understand the impact on outcomes every 6 months after the initial visit alongside the physician at the site.
Treatment Compliance Data (Every 3 months after Initial Visit)
时间窗: Every 3 months after Initial Visit up to 5 years
Collect data on treatment compliance that may impact the EPI due to CP disease experience and/or outcome every 3 months after the initial visit through a patient reported outcome (PRO).
Treatment Compliance Data (Every 6 months after Initial Visit)
时间窗: Every 6 months after Initial Visit up to 5 years
Collect data on treatment compliance that may impact the EPI due to CP disease experience and/or outcome every 6 months after the initial visit alongside the physician at the site.
Impact and Burden of EPI due to CP (Every 6 months after Initial Visit)
时间窗: Every 6 months after Initial Visit up to 5 years
Gather data on healthcare utilization to be combined with clinical data to generate evidence for the impact and burden of EPI due to CP in this cohort on the healthcare system every 6 months after the initial visit alongside the physician at the site.
Creation of a Patient Cohort
时间窗: Up to 5 years
Create a cohort of well-characterized patients with EPI due to CP research.
PRO Data
时间窗: Every 3 months after Initial Visit up to 5 years
Collect longitudinal participant-reported outcome (PRO) data every 3 months after Initial Visit.
Impact and Burden of EPI due to CP (Every 3 months after Initial Visit)
时间窗: Every 3 months after Initial Visit up to 5 years
Gather data on healthcare utilization to be combined with clinical data to generate evidence for the impact and burden of EPI due to CP in this cohort on the healthcare system every 3 months after the initial visit through a patient reported outcome (PRO).
次要结局
未报告次要终点