PAtient-CenTric Chronic Pancreatitis Registry (PACT-CP) (PACT-CP)

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Chronic Pancreatitis

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.

• Study Type: Observational
• Enrollment (Actual): 400

Contacts and Locations

• Study Contact: Name: Cindy Frommer; Phone Number: 508-408-5435; Email: epiregistry@corevitas.com

Study Locations

• United States
  • Massachusetts
    • Waltham, Massachusetts, United States, 02451
      • CorEvitas

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• 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.

Description

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.

      -

      Exclusion Criteria:

      -

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: CorEvitas
• Collaborators: Nestle Health Science
• Investigators: Study Chair: 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 record dates

Study Major Dates

• Study Start (Actual): June 2, 2021
• Primary Completion (Estimated): August 31, 2025
• Study Completion (Estimated): August 31, 2025

Study Registration Dates

• First Submitted: January 20, 2022
• First Submitted That Met QC Criteria: February 28, 2023
• First Posted (Actual): March 9, 2023

Study Record Updates

• Last Update Posted (Actual): April 4, 2024
• Last Update Submitted That Met QC Criteria: April 3, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Disease Attributes; Pancreatic Diseases; Chronic Disease; Pancreatitis; Pancreatitis, Chronic
• Other Study ID Numbers: NES-EPI-100

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No