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Completed

NCT Number: NCT05762445

PAtient-CenTric Chronic Pancreatitis Registry (PACT-CP)

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

CorEvitas

Waltham, Massachusetts, 02451, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

To be eligible for enrollment, a study participant must meet the inclusion criteria below:

  • 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.

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Exclusion criteria

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Treatment and study plan

Primary outcomes

  1. Main Objective of the Study

    Time frame: 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).

  2. Creation of a Patient Cohort

    Time frame: Up to 5 years

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

  3. Disease History and Progression Data at Initial Visit

    Time frame: At Initial Visit

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

  4. Progression Data (Every 3 months after Initial Visit)

    Time frame: 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).

  5. Progression Data (Every 6 months after Initial Visit)

    Time frame: 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.

  6. Clinical Care Practice Data at Initial Visit

    Time frame: At Initial Visit

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

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

    Time frame: 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).

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

    Time frame: 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.

  9. Treatment Compliance Data at Initial Visit

    Time frame: 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.

  10. Treatment Compliance Data (Every 3 months after Initial Visit)

    Time frame: 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).

  11. Treatment Compliance Data (Every 6 months after Initial Visit)

    Time frame: 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.

  12. Baseline Data

    Time frame: At Initial Visit

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

  13. PRO Data

    Time frame: Every 3 months after Initial Visit up to 5 years

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

  14. Impact and Burden of EPI due to CP Data at Initial Visit

    Time frame: 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.

  15. Impact and Burden of EPI due to CP (Every 3 months after Initial Visit)

    Time frame: 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).

  16. Impact and Burden of EPI due to CP (Every 6 months after Initial Visit)

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

CorEvitas

Network

Collaborators

  • Nestle Health Science

Registry information

Official study title

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

Acronym: PACT-CP

Important dates

Study start
2021
Primary completion
2025
Study completion
2025
First posted
Mar 9, 2023
Registry last updated
Jan 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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