Exocrine Pancreatic InsufficiencyPhase 4PERT-APNCT06477159
Pancreatic Enzyme Replacement Therapy for Acute Pancreatitis-Associated Exocrine Pancreatic Insufficiency
A Phase 4 study testing Pancrelipase Capsules in people with Exocrine Pancreatic Insufficiency, run by Ohio State University at 6 sites in United States.
Trial summary
This study aims to evaluate if a 6-month course of pancrelipase (CREON) treatment improves symptoms of exocrine pancreatic insufficiency (EPI) after an attack of acute pancreatitis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Exocrine Pancreatic Insufficiency
- What is being tested?
- Pancrelipase Capsules
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 6 sitesUnited States
- Study dates
- 1 Feb 2024to 31 Dec 2027
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
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
Who may be able to join
- Adult patients of age 18 or older, able to provide informed consent and follow all study procedures.
- Stable outpatient up to 12 months following an acute pancreatitis episode and has EPI based on an FE-1 < 200 µg/g stool obtained within 3 months prior to baseline assessment (Visit 2).
- Score of equal or greater 0.6 on the EPI symptom tracker at baseline Visit 2.
- Must be off PERT (including prescription and non-prescription enzymes) for 7 days prior to baseline Visit 2.
- Must have fully completed the terminal intervention for necrotizing pancreatitis (surgical or endoscopic necrosectomy or percutaneous drainage).
- Have a Body Weight between 40 and 120 kg (amounts to 600-1800 LU/meal pancrelipase starting dose of pancrelipase).
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- Women of childbearing potential must have a negative urine pregnancy test at Study Day 1 and practicing at least one protocol specified method of birth control (Section 5.2.4), starting at Study Day 1 through 30 days after last dose of pancrelipase.
- Females of non-childbearing potential (either postmenopausal or permanently surgically sterile as defined:
- Age > 55 years with no menses for 12 or more months without an alternative medical cause.
- Age ≤ 55 years with no menses for 12 or more months without an alternative medical cause AND an FSH level > 40 IU/L.
- OR
- Permanently surgical sterile (bilateral oophorectomy, bilateral salpingectomy or hysterectomy).
- do not require pregnancy testing.
Who cannot join
- Acute pancreatitis episode due to a pancreatic cystic neoplasm, trauma, or surgery. Post-ERCP acute pancreatitis patients can be enrolled.
- History of definite chronic pancreatitis defined by APA Chronic Pancreatitis Guideline.1
- Pancreas malignancy or other active malignancies requiring systemic treatment; treated basal cell carcinoma, and treated in-situ cervical cancer can be included.
- Enteropathies, and gastroenteritis that may affect FE-1 levels, e.g., Inflammatory bowel disease, Celiac Disease, viral-, bacterial-, fungal-, or parasitic gastroenteritis.
- Gastroparesis.
- Confirmed or suspected cystic tumor associated with main pancreatic duct dilation or believed to be the cause of AP (in the site-PI's judgment).
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- Prior pancreatic surgery or GI tract surgery affecting the upper GI tract including but not limited to gastric bypass surgery, total pancreatectomy.
- Pregnancy or breast feeding.
- Patients with life expectancy of less than 6 months due to advanced chronic conditions, such as congestive heart failure or chronic obstructive pulmonary disease, or other conditions which preclude study participation by judgement of the investigator.
- Incarcerated individuals
Trial locations and contacts
6 sites in 1 country. Contact the study team or a site near you to ask about taking part.
6 sites in 1 country
United States6 sites, 5 recruiting
- Recruiting
University of Illinois Chicago
Chicago, Illinois, 60612
Haya Alrashdan, MSN, 312-413-0306, halras2@uic.edu
Cemal Yazici, MD
- Recruiting
The Ohio State University
Columbus, Ohio, 43210
Zoe Krebs, BA, 614-685-3619, zoe.krebs@osumc.edu
Samantha Terhorst, MS, samantha.terhorst@osumc.edu
- Recruiting
University of Southern California
Los Angeles, California, 90033
Jorge Zuniga Gomez, jorge.zunigagomez@med.usc.edu
James Buxbaum, MD
- Not yet recruiting
University of Minnesota
Minneapolis, Minnesota, 55455
Cathy Kneeland, RN, kreel001@umn.edu
Guru Trikudanathan, MD
- Withdrawn
New York University Langone Medical Center
New York, New York, 10016
- Recruiting
University of Pittsburgh
Pittsburgh, Pennsylvania, 15213
Apsara Mishra, 412-624-9310, apm179@pitt.edu
Anna Phillips, MD
About this study
Official title: Pancreatic Enzyme Replacement Therapy for Acute Pancreatitis-Associated Exocrine Pancreatic Insufficiency: the PERT-AP Trial
This study aims to evaluate if a 6-month course of pancrelipase (CREON) treatment improves symptoms of exocrine pancreatic insufficiency (EPI) after an attack of acute pancreatitis. Diagnosis of EPI is measured by a fecal elastase value of <200, and patients must have a qualifying symptom burden based on the EPI symptom tracker survey. Blood and stool will be analyzed as part of this study, and other surveys of health status will be used to track improvement of symptoms.
Read the detailed description
This is a prospective, multi-center, open-label, single-arm study of pancrelipase (CREON) in eligible outpatient adults following an episode of acute pancreatitis. Following study eligibility evaluation and informed consent, patients will complete a 7-day run-in period without any pancreatic enzyme replacement therapy and complete baseline questionnaires and assessments, followed by a 180-day treatment period with pancrelipase. The study will end after a final 30 day-post pancrelipase treatment observation period during which safety events will be collected, and EPI symptom burden as well as stool frequency and consistency will be assessed as primary outcomes.
- Conditions
- Exocrine Pancreatic Insufficiency
- Being tested
- Pancrelipase Capsules
- Medical subject headings
- Exocrine Pancreatic Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pancrelipase CapsulesDrug
Also called CREON
Treatment with Pancreatic Enzyme Replacement Therapy
| Study group | Role | What they receive |
|---|---|---|
| Pancrelipase | Experimental | Pancrelipase (CREON) capsules taken orally with food, at a dose 36,000 units with snacks and 72,000 units with meals, for a total of 6 months (180 days) Receives: Drug: Pancrelipase Capsules |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient-Reported EPI Symptoms - Short Term
Determine the patient-reported change in total Exocrine Pancreatic Insufficiency (EPI) symptom score as measured by the EPI Symptom Tracker from baseline to 30 days of pancrelipase treatment; scored from 0 - 3, 0 being no symptoms and 3 being worst possible symptoms.
Measured: 30 days
Secondary outcomes (11)
Patient-Reported EPI Symptoms - LongTerm
Determine the patient-reported change in total Exocrine Pancreatic Insufficiency (EPI)symptom score as measured by the EPI Symptom Tracker from baseline to the end of pancrelipase treatment (180 days); scored from 0 - 3, 0 being no symptoms and 3 being worst possible symptoms.
Measured: 180 days
Change in Stool Frequency
Record changes in stool frequency from baseline to 30 days and from baseline to the end of pancrelipase treatment (180 days)
Measured: 180 days
Change in Stool Consistency
Record change in stool consistency from baseline to 30 days and from baseline to the end of pancrelipase treatment
Measured: 180 days
Change in Depression Score
Change in depression score assessed by the Patient Health Questionnaire (PHQ-9) from baseline to 30 days and from baseline to end of pancrelipase treatment; scores range from 0 - 27, with a higher score meaning worse depression symptoms
Measured: 180 days
Change in SF-12 Health Score
Change in self-assessment of health status as assessed by the 12-Item Short Form Survey (SF-12) from baseline to 30 days and from baseline to end of pancrelipase treatment (180 days); form is not numerically scored
Measured: 180 days
Change in Global Health Score
Change in Global Health score assessed by the Global Health (PROMIS) Questionnaire. Each question is scored 1 - 5, with high values indicating better health status in the first part of the form, and high values indicating poor health status in the latter part of the form; also included is a 0-10 average pain scale.
Measured: 180 days
Medication Adherence
Medication adherence to be assessed by pill count and questions about dosing compliance in previous two weeks.
Measured: 180 days
Change in Nutrition Biomarkers - Vitamin D
Change in serum nutrition biomarker Vitamin D (ng/mL)
Measured: 180 days
Change in Nutrition Biomarkers - Retinol Binding Protein
Change in serum nutrition biomarker Retinol Binding Protein (mg/dL)
Measured: 180 days
Change in Nutrition Biomarkers - Pre-albumin
Change in serum nutrition biomarker Pre-albumin (mg/dL)
Measured: 180 days
Change in Nutrition Biomarkers - Albumin
Change in serum nutrition biomarker Albumin (g/dL)
Measured: 180 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2024
- Study start1 Feb 2024
- Primary completion30 Sep 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Exocrine Pancreatic InsufficiencyStudies of the same condition, open and under way.
- More trials run by Ohio State UniversityThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ohio State University
- Sponsor type
- University, hospital or other
- Collaborators
- University of Pittsburgh, University of Illinois at Chicago, University of Southern California, New York University, AbbVie, University of Minnesota
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06477159
- Sponsor's protocol ID
- 2023H0394
- Acronym
- PERT-AP
- Status last verified
- Jun 2026
- First submitted
- 13 May 2024
- Last updated
- 10 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pancreatic Enzyme Replacement Therapy for Acute Pancreatitis-Associated Exocrine Pancreatic Insufficiency: the PERT-AP Trial
- ClinicalTrials.gov ID
- NCT06477159
- Acronym / sponsor ID
- PERT-AP / 2023H0394
- Conditions
- Exocrine Pancreatic Insufficiency
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Ohio State UniversityUniversity, hospital or other
- Collaborators
- University of Pittsburgh, University of Illinois at Chicago, University of Southern California, New York University, AbbVie, University of Minnesota
- Study start
- 1 Feb 2024 (actual)
- Primary completion
- 30 Sep 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 27 Jun 2024 (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.
This study aims to evaluate if a 6-month course of pancrelipase (CREON) treatment improves symptoms of exocrine pancreatic insufficiency (EPI) after an attack of acute pancreatitis. Diagnosis of EPI is measured by a fecal elastase value of <200, and patients must have a qualifying symptom burden based on the EPI symptom tracker survey. Blood and stool will be analyzed as part of this study, and other surveys of health status will be used to track improvement of symptoms.
Detailed description
This is a prospective, multi-center, open-label, single-arm study of pancrelipase (CREON) in eligible outpatient adults following an episode of acute pancreatitis. Following study eligibility evaluation and informed consent, patients will complete a 7-day run-in period without any pancreatic enzyme replacement therapy and complete baseline questionnaires and assessments, followed by a 180-day treatment period with pancrelipase. The study will end after a final 30 day-post pancrelipase treatment observation period during which safety events will be collected, and EPI symptom burden as well as stool frequency and consistency will be assessed as primary outcomes.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pancrelipase | Experimental | Drug: Pancrelipase CapsulesPancrelipase (CREON) capsules taken orally with food, at a dose 36,000 units with snacks and 72,000 units with meals, for a total of 6 months (180 days) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Adult patients of age 18 or older, able to provide informed consent and follow all study procedures.
- Stable outpatient up to 12 months following an acute pancreatitis episode and has EPI based on an FE-1 < 200 µg/g stool obtained within 3 months prior to baseline assessment (Visit 2).
- Score of equal or greater 0.6 on the EPI symptom tracker at baseline Visit 2.
- Must be off PERT (including prescription and non-prescription enzymes) for 7 days prior to baseline Visit 2.
- Must have fully completed the terminal intervention for necrotizing pancreatitis (surgical or endoscopic necrosectomy or percutaneous drainage).
Key exclusion criteria (10 listed)
- Acute pancreatitis episode due to a pancreatic cystic neoplasm, trauma, or surgery. Post-ERCP acute pancreatitis patients can be enrolled.
- History of definite chronic pancreatitis defined by APA Chronic Pancreatitis Guideline.1
- Pancreas malignancy or other active malignancies requiring systemic treatment; treated basal cell carcinoma, and treated in-situ cervical cancer can be included.
- Enteropathies, and gastroenteritis that may affect FE-1 levels, e.g., Inflammatory bowel disease, Celiac Disease, viral-, bacterial-, fungal-, or parasitic gastroenteritis.
- Gastroparesis.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pancrelipase CapsulesAlso: CREONTreatment with Pancreatic Enzyme Replacement Therapy | Drug | Pancrelipase |
Primary outcome
Patient-Reported EPI Symptoms - Short Term
Time frame: 30 days
Determine the patient-reported change in total Exocrine Pancreatic Insufficiency (EPI) symptom score as measured by the EPI Symptom Tracker from baseline to 30 days of pancrelipase treatment; scored from 0 - 3, 0 being no symptoms and 3 being worst possible symptoms.
11 secondary outcomes
Patient-Reported EPI Symptoms - LongTerm
Time frame: 180 days
Change in Stool Frequency
Time frame: 180 days
Change in Stool Consistency
Time frame: 180 days
Change in Depression Score
Time frame: 180 days
Change in SF-12 Health Score
Time frame: 180 days
Change in Global Health Score
Time frame: 180 days
Medication Adherence
Time frame: 180 days
Change in Nutrition Biomarkers - Vitamin D
Time frame: 180 days
Change in Nutrition Biomarkers - Retinol Binding Protein
Time frame: 180 days
Change in Nutrition Biomarkers - Pre-albumin
Time frame: 180 days
Change in Nutrition Biomarkers - Albumin
Time frame: 180 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jun 2026.
- Individual participant dataSharing planned: Undecided
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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.
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Pancrelipase Capsules in people with Exocrine Pancreatic Insufficiency, run by Ohio State University at 6 sites 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 13 inclusion and 10 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: looking for participants now, as of the sponsor's last update on 10 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Zoe Krebs (614-685-3619, zoe.krebs@osumc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient-Reported EPI Symptoms - Short Term (time frame: 30 days). 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 10 Jun 2026; AzTrials last refreshed its copy on 26 Oct 2026.