Ignite Creation Date:
2025-12-24 @ 3:06 PM
Ignite Modification Date:
2026-01-19 @ 5:21 PM
Study NCT ID:
NCT06477159
Status:
RECRUITING
Last Update Posted:
2025-10-22
First Post:
2024-05-13
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pancreatic Enzyme Replacement Therapy for Acute Pancreatitis-Associated Exocrine Pancreatic Insufficiency
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010188', 'term': 'Exocrine Pancreatic Insufficiency'}], 'ancestors': [{'id': 'D010182', 'term': 'Pancreatic Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D020799', 'term': 'Pancrelipase'}], 'ancestors': [{'id': 'D008049', 'term': 'Lipase'}, {'id': 'D002265', 'term': 'Carboxylic Ester Hydrolases'}, {'id': 'D004950', 'term': 'Esterases'}, {'id': 'D006867', 'term': 'Hydrolases'}, {'id': 'D004798', 'term': 'Enzymes'}, {'id': 'D045762', 'term': 'Enzymes and Coenzymes'}, {'id': 'D010184', 'term': 'Pancreatic Extracts'}, {'id': 'D014020', 'term': 'Tissue Extracts'}, {'id': 'D045424', 'term': 'Complex Mixtures'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-02-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-10', 'completionDateStruct': {'date': '2027-07-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-10-20', 'studyFirstSubmitDate': '2024-05-13', 'studyFirstSubmitQcDate': '2024-06-21', 'lastUpdatePostDateStruct': {'date': '2025-10-22', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2024-06-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Frequency, Type, and Severity of Adverse Events', 'timeFrame': '210 days', 'description': 'Evaluate the frequency, severity, and causality of adverse events (AEs), treatment emergent AEs (TEAEs), and serious AEs (SAEs); Descriptive assessment of safety and tolerability using FAS set with AEs collected from time of consent to 30 days after end of pancrelipase treatment'}, {'measure': 'Patient-Reported EPI Symptoms - Post-Treatment', 'timeFrame': '210 days', 'description': 'Change in total Exocrine Pancreatic Insufficiency (EPI) symptom score as measured by the EPI Symptom Tracker from end of pancrelipase treatment to end of 30-day follow-up period; scored from 0 - 3, 0 being no symptoms and 3 being worst possible symptoms.'}, {'measure': 'Change in Stool Frequency', 'timeFrame': '210 days', 'description': 'Change in stool frequency from end of pancrelipase treatment to end of 30-day follow-up period'}, {'measure': 'Change in Stool Consistency', 'timeFrame': '210 days', 'description': 'Change in stool consistency from end of pancrelipase treatment to end of 30-day follow-up period'}], 'primaryOutcomes': [{'measure': 'Patient-Reported EPI Symptoms - Short Term', 'timeFrame': '30 days', 'description': '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.'}], 'secondaryOutcomes': [{'measure': 'Patient-Reported EPI Symptoms - LongTerm', 'timeFrame': '180 days', 'description': '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.'}, {'measure': 'Change in Stool Frequency', 'timeFrame': '180 days', 'description': 'Record changes in stool frequency from baseline to 30 days and from baseline to the end of pancrelipase treatment (180 days)'}, {'measure': 'Change in Stool Consistency', 'timeFrame': '180 days', 'description': 'Record change in stool consistency from baseline to 30 days and from baseline to the end of pancrelipase treatment'}, {'measure': 'Change in Depression Score', 'timeFrame': '180 days', 'description': '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'}, {'measure': 'Change in SF-12 Health Score', 'timeFrame': '180 days', 'description': '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'}, {'measure': 'Change in Global Health Score', 'timeFrame': '180 days', 'description': '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.'}, {'measure': 'Medication Adherence', 'timeFrame': '180 days', 'description': 'Medication adherence assessed by pill count and the Morisky Medication Adherence Scale (MMAS-8) from baseline to 30 days of pancrelipase treatment and from 30 days to end of pancrelipase treatment (180 days); A score below 6 indicates low adherence, and a score of 8 high adherence. Scale ranges from 0 - 8.'}, {'measure': 'Change in Nutrition Biomarkers - Vitamin D', 'timeFrame': '180 days', 'description': 'Change in serum nutrition biomarker Vitamin D (ng/mL)'}, {'measure': 'Change in Nutrition Biomarkers - Retinol Binding Protein', 'timeFrame': '180 days', 'description': 'Change in serum nutrition biomarker Retinol Binding Protein (mg/dL)'}, {'measure': 'Change in Nutrition Biomarkers - Pre-albumin', 'timeFrame': '180 days', 'description': 'Change in serum nutrition biomarker Pre-albumin (mg/dL)'}, {'measure': 'Change in Nutrition Biomarkers - Albumin', 'timeFrame': '180 days', 'description': 'Change in serum nutrition biomarker Albumin (g/dL)'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Exocrine Pancreatic Insufficiency']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Adult patients of age 18 or older, able to provide informed consent and follow all study procedures.\n2. 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).\n3. Score of equal or greater 0.6 on the EPI symptom tracker at baseline Visit 2.\n4. Must be off PERT (including prescription and non-prescription enzymes) for 7 days prior to baseline Visit 2.\n5. Must have fully completed the terminal intervention for necrotizing pancreatitis (surgical or endoscopic necrosectomy or percutaneous drainage).\n6. Have a Body Weight between 40 and 120 kg (amounts to 600-1800 LU/meal pancrelipase starting dose of pancrelipase).\n7. 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.\n8. Females of non-childbearing potential (either postmenopausal or permanently surgically sterile as defined:\n\n * Age \\> 55 years with no menses for 12 or more months without an alternative medical cause.\n * Age ≤ 55 years with no menses for 12 or more months without an alternative medical cause AND an FSH level \\> 40 IU/L.\n\nOR\n\n* Permanently surgical sterile (bilateral oophorectomy, bilateral salpingectomy or hysterectomy).\n\ndo not require pregnancy testing.\n\nExclusion Criteria:\n\n1. Acute pancreatitis episode due to a pancreatic cystic neoplasm, trauma, or surgery. Post-ERCP acute pancreatitis patients can be enrolled.\n2. History of definite chronic pancreatitis defined by APA Chronic Pancreatitis Guideline.1\n3. Pancreas malignancy or other active malignancies requiring systemic treatment; treated basal cell carcinoma, and treated in-situ cervical cancer can be included.\n4. Enteropathies, and gastroenteritis that may affect FE-1 levels, e.g., Inflammatory bowel disease, Celiac Disease, viral-, bacterial-, fungal-, or parasitic gastroenteritis.\n5. Gastroparesis.\n6. 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).\n7. Prior pancreatic surgery or GI tract surgery affecting the upper GI tract including but not limited to gastric bypass surgery, total pancreatectomy.\n8. Pregnancy or breast feeding.\n9. 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.\n10. Incarcerated individuals"}, 'identificationModule': {'nctId': 'NCT06477159', 'acronym': 'PERT-AP', 'briefTitle': 'Pancreatic Enzyme Replacement Therapy for Acute Pancreatitis-Associated Exocrine Pancreatic Insufficiency', 'organization': {'class': 'OTHER', 'fullName': 'Ohio State University'}, 'officialTitle': 'Pancreatic Enzyme Replacement Therapy for Acute Pancreatitis-Associated Exocrine Pancreatic Insufficiency: the PERT-AP Trial', 'orgStudyIdInfo': {'id': '2023H0394'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Pancrelipase', 'description': '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)', 'interventionNames': ['Drug: Pancrelipase Capsules']}], 'interventions': [{'name': 'Pancrelipase Capsules', 'type': 'DRUG', 'otherNames': ['CREON'], 'description': 'Treatment with Pancreatic Enzyme Replacement Therapy', 'armGroupLabels': ['Pancrelipase']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90033', 'city': 'Los Angeles', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Alejandro Vazquez', 'role': 'CONTACT', 'email': 'alejandro.vazquez@med.usc.edu'}, {'name': 'James Buxbaum, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'University of Southern California', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '60612', 'city': 'Chicago', 'state': 'Illinois', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Haya Alrashdan, MSN', 'role': 'CONTACT', 'email': 'halras2@uic.edu', 'phone': '312-413-0306'}, {'name': 'Cemal Yazici, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'University of Illinois Chicago', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '10016', 'city': 'New York', 'state': 'New York', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Emil Agarunov', 'role': 'CONTACT', 'email': 'Emil.Agarunov@nyulangone.org'}, {'name': 'Tamas A. Gonda, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'New York University Langone Medical Center', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '43210', 'city': 'Columbus', 'state': 'Ohio', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Zoe Krebs, BA', 'role': 'CONTACT', 'email': 'zoe.krebs@osumc.edu', 'phone': '614-685-3619'}, {'name': 'Samantha Terhorst, MS', 'role': 'CONTACT', 'email': 'samantha.terhorst@osumc.edu'}, {'name': 'Georgios Papachristou, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Peter Lee, MbCHb', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'The Ohio State University', 'geoPoint': {'lat': 39.96118, 'lon': -82.99879}}, {'zip': '15213', 'city': 'Pittsburgh', 'state': 'Pennsylvania', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Apsara Mishra', 'role': 'CONTACT', 'email': 'apm179@pitt.edu', 'phone': '412-624-9310'}, {'name': 'Jennifer S. Chennat, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'University of Pittsburgh', 'geoPoint': {'lat': 40.44062, 'lon': -79.99589}}], 'centralContacts': [{'name': 'Zoe Krebs, BA', 'role': 'CONTACT', 'email': 'zoe.krebs@osumc.edu', 'phone': '614-685-3619'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ohio State University', 'class': 'OTHER'}, 'collaborators': [{'name': 'University of Pittsburgh', 'class': 'OTHER'}, {'name': 'University of Illinois Chicago', 'class': 'UNKNOWN'}, {'name': 'University of Southern California', 'class': 'OTHER'}, {'name': 'New York University', 'class': 'OTHER'}, {'name': 'AbbVie', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}