Treatment for digestive issues after acute pancreatitis

Pancreatic Enzyme Replacement Therapy for Acute Pancreatitis-Associated Exocrine Pancreatic Insufficiency: the PERT-AP Trial

This study is testing if a 6-month treatment with pancrelipase can help adults with digestive problems after having acute pancreatitis feel better.

Quick facts

• Phase: Phase 4
• Study type: Interventional
• Enrollment: 60 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Ohio State University (Academic / other)
• Locations: 5 sites (Los Angeles, California and 4 other locations)
• Trial ID: NCT06477159 on ClinicalTrials.gov

What this trial studies

This study evaluates the effectiveness of a 6-month treatment with pancrelipase (CREON) for adults suffering from exocrine pancreatic insufficiency (EPI) following an episode of acute pancreatitis. Participants will undergo a 7-day run-in period without pancreatic enzyme replacement therapy, followed by a 180-day treatment phase with pancrelipase. The study will assess symptom improvement through blood and stool analysis, as well as health status surveys, concluding with a 30-day post-treatment observation period to monitor safety and symptom burden.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older who have experienced acute pancreatitis and have been diagnosed with EPI.

Not a fit: Patients who are not stable after an acute pancreatitis episode or those who have not completed necessary surgical interventions may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly improve digestive health and quality of life for patients with EPI after acute pancreatitis.

How similar studies have performed: Previous studies have shown positive outcomes with pancrelipase treatment for EPI, indicating a potential for success in this approach.

Eligibility criteria

Inclusion Criteria:

1. Adult patients of age 18 or older, able to provide informed consent and follow all study procedures.
2. 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).
3. Score of equal or greater 0.6 on the EPI symptom tracker at baseline Visit 2.
4. Must be off PERT (including prescription and non-prescription enzymes) for 7 days prior to baseline Visit 2.
5. Must have fully completed the terminal intervention for necrotizing pancreatitis (surgical or endoscopic necrosectomy or percutaneous drainage).
6. Have a Body Weight between 40 and 120 kg (amounts to 600-1800 LU/meal pancrelipase starting dose of pancrelipase).
7. 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.
8. 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.

Exclusion Criteria:

1. Acute pancreatitis episode due to a pancreatic cystic neoplasm, trauma, or surgery. Post-ERCP acute pancreatitis patients can be enrolled.
2. History of definite chronic pancreatitis defined by APA Chronic Pancreatitis Guideline.1
3. Pancreas malignancy or other active malignancies requiring systemic treatment; treated basal cell carcinoma, and treated in-situ cervical cancer can be included.
4. Enteropathies, and gastroenteritis that may affect FE-1 levels, e.g., Inflammatory bowel disease, Celiac Disease, viral-, bacterial-, fungal-, or parasitic gastroenteritis.
5. Gastroparesis.
6. 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).
7. Prior pancreatic surgery or GI tract surgery affecting the upper GI tract including but not limited to gastric bypass surgery, total pancreatectomy.
8. Pregnancy or breast feeding.
9. 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.
10. Incarcerated individuals

Where this trial is running

Los Angeles, California and 4 other locations

• University of Southern California — Los Angeles, California, United States (Recruiting)
• University of Illinois Chicago — Chicago, Illinois, United States (Recruiting)
• New York University Langone Medical Center — New York, New York, United States (Recruiting)
• The Ohio State University — Columbus, Ohio, United States (Recruiting)
• University of Pittsburgh — Pittsburgh, Pennsylvania, United States (Recruiting)

Study contacts

• Study coordinator: Zoe Krebs, BA

Conditions Exocrine Pancreatic Insufficiency