Chronic PancreatitisPACT-CPNCT05762445
PAtient-CenTric Chronic Pancreatitis Registry (PACT-CP)
An observational study of Chronic Pancreatitis, run by CorEvitas at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Pancreatitis
- How many people
- 400 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Jun 2021to 31 Aug 2025
- How long will I take part?
- 5 Years
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: This is a prospective, non-interventional study for individuals with EPI due to CP who are under the care of a gastroenterologist.
Who may be able to join
- 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)
Show all 17Show fewer
- 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.
- -
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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
- Medical subject headings
- Pancreatitis, Chronic
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Up to 5 years
Creation of a Patient Cohort
Create a cohort of well-characterized patients with EPI due to CP research.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: At Initial Visit
PRO Data
Collect longitudinal participant-reported outcome (PRO) data every 3 months after Initial Visit.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: Every 6 months after Initial Visit up to 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2023
- Study start2 Jun 2021
- Primary completion31 Aug 2025
- Study completion31 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic PancreatitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 400 participants (actual)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- CorEvitas
- Sponsor type
- Research network
- Collaborators
- Nestle Health Science
- Responsible party
- Sponsor
- Investigators
- David Whitcomb, MD, PhD, Study chair, Director, University of Pittsburgh Medical CenterJodie Barkin, MD, Study chair, University of Miami, Division of GastroenterologySamer Al-Kaade, MD, Study chair, Mercy Clinic GastroenterologyYasmin Hernandez-Barco, MD, Study chair, Harvard School of Medicine, Division of Gastroenterology and HepatologyRahul Pannala, MD, Study chair, Mayo Clinic College of Medicine and Science
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05762445
- Sponsor's protocol ID
- NES-EPI-100
- Acronym
- PACT-CP
- Status last verified
- Jan 2026
- First submitted
- 20 Jan 2022
- Last updated
- 22 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Patient-Driven Registry for Exocrine Pancreatic Insufficiency Due to Chronic Pancreatitis
- ClinicalTrials.gov ID
- NCT05762445
- Acronym / sponsor ID
- PACT-CP / NES-EPI-100
- Conditions
- Chronic Pancreatitis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 400 participants (actual)
- Lead sponsor
- CorEvitasResearch network
- Collaborators
- Nestle Health Science
- Study start
- 2 Jun 2021 (actual)
- Primary completion
- 31 Aug 2025 (actual)
- Study completion
- 31 Aug 2025 (actual)
- First posted
- 9 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 5 Years
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This is a prospective, non-interventional study for individuals with EPI due to CP who are under the care of a gastroenterologist.
Key inclusion criteria (17 listed)
- 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:
- Suspected or confirmed diagnosis of EPI made by a healthcare provider
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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).
Creation of a Patient Cohort
Time frame: Up to 5 years
Create a cohort of well-characterized patients with EPI due to CP research.
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.
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).
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.
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.
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).
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.
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.
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).
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.
Baseline Data
Time frame: At Initial Visit
Collect baseline data of participants with EPI due to CP at the initial visit.
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.
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.
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).
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David Whitcomb, MD, PhD study chair
Director, University of Pittsburgh Medical Center
Jodie Barkin, MD study chair
University of Miami, Division of Gastroenterology
Samer Al-Kaade, MD study chair
Mercy Clinic Gastroenterology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Pancreatitis, run by CorEvitas at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 17 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Main Objective of the Study (time frame: Up to 5 years). The study lists 16 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jan 2026.