NCT05762445

PAtient-CenTric Chronic Pancreatitis Registry (PACT-CP)

A Patient-Driven Registry for Exocrine Pancreatic Insufficiency Due to Chronic Pancreatitis

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 400 (actual)
• Sponsor: CorEvitas · Network
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Chronic Pancreatitis

Timeline

• Start date: 2021-06-02
• Primary completion: 2025-08-31
• Completion: 2025-08-31
• First posted: 2023-03-09
• Last updated: 2026-01-22

Locations

1 site across 1 country: United States