PAtient-CenTric Chronic Pancreatitis Registry (PACT-CP)

NCT05762445 | Completed

• 1 other identifier: NES-EPI-100
• Study Type: observational
• Target: 400
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Chronic Pancreatitis

Outcome Measures

Primary Outcomes (16)

• Main Objective of the Study

  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).

  Up to 5 years

• Creation of a Patient Cohort

  Create a cohort of well-characterized patients with EPI due to CP research.

  Up to 5 years

• Disease History and Progression Data at Initial Visit

  Collect clinical data to characterize both the EPI due to CP disease history and disease progression at the initial visit.

  At Initial Visit

• Progression Data (Every 3 months after Initial Visit)

  Collect clinical data to characterize EPI due to CP disease progression every 3 months after the initial visit through a patient reported outcome (PRO).

  Every 3 months after Initial Visit up to 5 years

• Progression Data (Every 6 months after Initial Visit)

  Collect clinical data to characterize EPI due to CP disease progression every 6 months after the initial visit alongside the physician at the site.

  Every 6 months after Initial Visit up to 5 years

• Clinical Care Practice Data at Initial Visit

  Collect data on clinical care practices for participants with EPI to better understand the impact on outcomes at the initial visit.

  At Initial Visit

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

  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).

  Every 3 months after Initial Visit up to 5 years

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

  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.

  Every 6 months after Initial Visit up to 5 years

• Treatment Compliance Data 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.

  At Initial Visit

• Treatment Compliance Data (Every 3 months after Initial Visit)

  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).

  Every 3 months after Initial Visit up to 5 years

• Treatment Compliance Data (Every 6 months after Initial Visit)

  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.

  Every 6 months after Initial Visit up to 5 years

• Baseline Data

  Collect baseline data of participants with EPI due to CP at the initial visit.

  At Initial Visit

• PRO Data

  Collect longitudinal participant-reported outcome (PRO) data every 3 months after Initial Visit.

  Every 3 months after Initial Visit up to 5 years

• Impact and Burden of EPI due to CP Data 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.

  At Initial Visit

• Impact and Burden of EPI due to CP (Every 3 months after 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 every 3 months after the initial visit through a patient reported outcome (PRO).

  Every 3 months after Initial Visit up to 5 years

• Impact and Burden of EPI due to CP (Every 6 months after 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 every 6 months after the initial visit alongside the physician at the site.

  Every 6 months after Initial Visit up to 5 years

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

This is a prospective, non-interventional study for individuals with EPI due to CP who are under the care of a gastroenterologist.

You may qualify if:

• 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.

Sponsors & Collaborators

• CorEvitas: lead
• Nestle Health Science: collaborator

Study Sites (1)

CorEvitas

Waltham, Massachusetts, 02451, United States

Location

MeSH Terms

Conditions

Pancreatitis, Chronic

Condition Hierarchy (Ancestors)

Pancreatitis; Pancreatic Diseases; Digestive System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• David Whitcomb, MD, PhD

  Director, University of Pittsburgh Medical Center

  STUDY CHAIR

• Jodie Barkin, MD

  University of Miami, Division of Gastroenterology

  STUDY CHAIR

• Samer Al-Kaade, MD

  Mercy Clinic Gastroenterology

  STUDY CHAIR

• Yasmin Hernandez-Barco, MD

  Harvard School of Medicine, Division of Gastroenterology and Hepatology

  STUDY CHAIR

• Rahul Pannala, MD

  Mayo Clinic College of Medicine and Science

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 5 Years
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 20, 2022
• First Posted: March 9, 2023
• Study Start: June 2, 2021
• Primary Completion: August 31, 2025
• Study Completion: August 31, 2025
• Last Updated: January 22, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)