PAtient-CenTric Chronic Pancreatitis Registry (PACT-CP)

NCT ID: NCT05762445

Last Updated: 2026-01-22

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 400 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-06-02
• Study Completion Date: 2025-08-31

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.

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Eligibility Criteria

Inclusion Criteria

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

-

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Nestle Health Science

INDUSTRY

Sponsor Role: collaborator

CorEvitas

NETWORK

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

David Whitcomb, MD, PhD

Role: STUDY_CHAIR

Director, University of Pittsburgh Medical Center

Jodie Barkin, MD

Role: STUDY_CHAIR

University of Miami, Division of Gastroenterology

Samer Al-Kaade, MD

Role: STUDY_CHAIR

Mercy Clinic Gastroenterology

Yasmin Hernandez-Barco, MD

Role: STUDY_CHAIR

Harvard School of Medicine, Division of Gastroenterology and Hepatology

Rahul Pannala, MD

Role: STUDY_CHAIR

Mayo Clinic College of Medicine and Science

Locations

CorEvitas

Waltham, Massachusetts, United States

Countries

United States

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

NES-EPI-100

Identifier Type: -

Identifier Source: org_study_id