PAtient-CenTric Chronic Pancreatitis Registry (PACT-CP)

CorEvitas

Status: Completed

Conditions: Chronic Pancreatitis

Study type: Observational

Funder types: NETWORK; Industry

Identifiers

NCT05762445

NES-EPI-100

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 400 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

To be eligible for enrollment, a study participant must meet the inclusion criteria below:

1. At least 18 years of age (or age of majority)

2. Willing to provide consent to participate

3. Meet one (1) of the following at the time of enrollment:

   1. Diagnosis of chronic pancreatitis (CP)
   2. Diagnosis of recurrent acute pancreatitis (RAP)

4. Suspected or confirmed diagnosis of EPI made by a healthcare provider

5. 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:

1. Currently participating in or planning to participate in a double-blind randomized trial and/or open-label Phase 3b/4 on CP or EPI

2. Diagnosed with any of the following conditions at the time of enrollment:

   1. Cystic fibrosis

   2. Fibrosing colonopathy

   3. A history of or current diagnosis of pancreatic cancer, main duct papillary mucinous neoplasms (IPMNs), and other pancreatic malignancies

   4. Allergy to pork or other porcine pancreatic enzyme products (PEPs)

   5. Any condition that would, in the investigator's opinion, limit the individual's ability to complete the study.

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      Exclusion Criteria:

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Trial design