Pancreatic Enzyme Replacement Therapy for Acute Pancreatitis-Associated Exocrine Pancreatic Insufficiency

Launched by OHIO STATE UNIVERSITY · Jun 21, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a treatment called pancrelipase (also known as CREON) to see if it helps improve symptoms in adults with exocrine pancreatic insufficiency (EPI) that can happen after an episode of acute pancreatitis. EPI means that the pancreas isn't producing enough enzymes to help with digestion, leading to uncomfortable symptoms. To participate, patients must be 18 years or older, have experienced an acute pancreatitis episode within the last year, and have a specific measurement of enzyme levels in their stool. Participants will need to stop using any pancreatic enzyme supplements for a week before joining the trial, and they will be monitored for six months to track changes in their symptoms and overall health.

Eligible participants will be asked to complete surveys about their symptoms and provide blood and stool samples for analysis. This trial is currently looking for volunteers, and it's important to note that certain health conditions or recent surgeries may prevent someone from participating. If you or a loved one is interested in this study, it could be a good opportunity to explore a potential treatment for managing EPI.

Gender

ALL

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