CompletedNot Applicable

PAtient-CenTric Chronic Pancreatitis Registry (PACT-CP)

United States400 participantsStarted 2021-06-02

Plain-language 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.

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

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

What they're measuring

Main Objective of the Study

Timeframe: Up to 5 years

Creation of a Patient Cohort

Timeframe: Up to 5 years

Disease History and Progression Data at Initial Visit

Timeframe: At Initial Visit

Progression Data (Every 3 months after Initial Visit)

Timeframe: Every 3 months after Initial Visit up to 5 years

Progression Data (Every 6 months after Initial Visit)

Timeframe: Every 6 months after Initial Visit up to 5 years

Clinical Care Practice Data at Initial Visit

Timeframe: At Initial Visit

Clinical Care Practice Data (Every 3 months after Initial Visit)

Timeframe: Every 3 months after Initial Visit up to 5 years

Clinical Care Practice Data (Every 6 months after Initial Visit)

Timeframe: Every 6 months after Initial Visit up to 5 years

Trial details

NCT IDNCT05762445

SponsorCorEvitas

Sponsor typeNETWORK

Study typeOBSERVATIONAL

Primary completion2025-08-31

View on ClinicalTrials.gov More Chronic Pancreatitis trials

Plain-language summary

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

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

What they're measuring

Main Objective of the Study

Timeframe: Up to 5 years

Creation of a Patient Cohort

Timeframe: Up to 5 years

Disease History and Progression Data at Initial Visit

Timeframe: At Initial Visit

Progression Data (Every 3 months after Initial Visit)

Timeframe: Every 3 months after Initial Visit up to 5 years

Progression Data (Every 6 months after Initial Visit)

Timeframe: Every 6 months after Initial Visit up to 5 years

Clinical Care Practice Data at Initial Visit

Timeframe: At Initial Visit

Clinical Care Practice Data (Every 3 months after Initial Visit)

Timeframe: Every 3 months after Initial Visit up to 5 years

Clinical Care Practice Data (Every 6 months after Initial Visit)

Timeframe: Every 6 months after Initial Visit up to 5 years