PAtient-CenTric Chronic Pancreatitis Registry (PACT-CP)

Active, not recruiting

• Conditions: Chronic Pancreatitis

• Registration Number: NCT05762445
• Lead Sponsor: CorEvitas

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.

Study Timeline

• Study Start: 2021-06-02
• Study First Submitted: 2022-01-20
• Study First Submitted QC: 2023-02-28
• Study First Posted: 2023-03-09
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-03
• Last Update Posted: 2024-04-04
• Primary Completion: 2025-08-31
• Study Completion: 2025-08-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 400

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Progression Data (Every 6 months after Initial Visit)	Every 6 months after Initial Visit up to 5 years	Collect clinical data to characterize EPI due to CP disease progression every 6 months after the initial visit alongside the physician at the site.
Treatment Compliance Data at Initial Visit	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.
Baseline Data	At Initial Visit	Collect baseline data of participants with EPI due to CP at the initial visit.
Impact and Burden of EPI due to CP Data at Initial Visit	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.
Disease History and Progression Data at Initial Visit	At Initial Visit	Collect clinical data to characterize both the EPI due to CP disease history and disease progression at the initial visit.
Clinical Care Practice Data at Initial Visit	At Initial Visit	Collect data on clinical care practices for participants with EPI to better understand the impact on outcomes at the initial visit.
Clinical Care Practice Data (Every 3 months after Initial Visit)	Every 3 months after Initial Visit up to 5 years	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).
Main Objective of the Study	Up to 5 years	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).
Progression Data (Every 3 months after Initial Visit)	Every 3 months after Initial Visit up to 5 years	Collect clinical data to characterize EPI due to CP disease progression every 3 months after the initial visit through a patient reported outcome (PRO).
Clinical Care Practice Data (Every 6 months after Initial Visit)	Every 6 months after Initial Visit up to 5 years	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.
Treatment Compliance Data (Every 3 months after Initial Visit)	Every 3 months after Initial Visit up to 5 years	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).
Treatment Compliance Data (Every 6 months after Initial Visit)	Every 6 months after Initial Visit up to 5 years	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.
Impact and Burden of EPI due to CP (Every 6 months after Initial Visit)	Every 6 months after Initial Visit up to 5 years	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.
Creation of a Patient Cohort	Up to 5 years	Create a cohort of well-characterized patients with EPI due to CP research.
PRO Data	Every 3 months after Initial Visit up to 5 years	Collect longitudinal participant-reported outcome (PRO) data every 3 months after Initial Visit.
Impact and Burden of EPI due to CP (Every 3 months after Initial Visit)	Every 3 months after Initial Visit up to 5 years	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).

Trial Locations

Locations (1)

CorEvitas; 🇺🇸 Waltham, Massachusetts, United States