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Recruiting
NCT05762445
PAtient-CenTric Chronic Pancreatitis Registry (PACT-CP)
Conditions: Chronic Pancreatitis
Sex: All
Ages: 18 Years – N/A
Enrollment: 400
Sponsor: CorEvitas
Location: United States
Summary
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.
Eligibility Criteria
Inclusion Criteria: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 participateMeet 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 providerOn 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 EPIDiagnosed with any of the following conditions at the time of enrollment:Cystic fibrosisFibrosing colonopathyA history of or current diagnosis of pancreatic cancer, main duct papillary mucinous neoplasms (IPMNs), and other pancreatic malignanciesAllergy 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.-Exclusion Criteria:-
Source: ClinicalTrials.gov (NCT05762445). StuddyBuddy aggregates publicly available trial information.