RECRUITING

Evaluation of Pirfenidone as a Novel Therapeutic Strategy Against Recurrent Acute Pancreatitis.

Conditions

Quick Navigation

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

This clinical will evaluate the safety, tolerability and early efficacy of pirenidone in patients with recurrent acute pancreatitis.

Official Title

Evaluation of Pirfenidone as a Novel Therapeutic Strategy Against Recurrent Acute Pancreatitis.

Quick Facts

Study Start:2024-06-27

Study Completion:2028-02-01

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06253117

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 85 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
1. Patients 18 - 85 years of age 2. Two or more documented attacks of acute pancreatitis, separated by 3 months from one another, defined by at least 2 of the following 3: 1. amylase or lipase values, or both, that are greater than 3 times the upper limit of normal values 2. characteristic cross-sectional imaging 3. typical upper abdominal pain according to the revised Atlanta classification28 3. Drug/placebo treatment to start 1. Mild AP * Patient is discharged out of the hospital * 30 days after diagnosis of mild AP 2. Moderate Severe or Severe AP * Patient is discharged out of hospital * Intra-abdominal collections are either resolved on imaging, or are improving and asymptomatic and do not warrant any intervention (per treating physician) 4. Ability to understand and the willingness to sign a written informed consent document and medical release 5. Willing and able to comply with trial protocol and follow up 6. 2nd AP episode despite correction of the AP etiology (if identified) after the 1st episode as follows i. Patients with biliary pancreatitis who have undergone cholecystectomy, with or without ERCP (if indicated) ii. Patients with hypertriglyceridemia induced pancreatitis who have serum triglyceride levels below 250 with medication management iii. Patients with medication induced AP developing a 2nd AP episode despite stopping the culprit medication	1. Age \< 18 or \> 85 years. 2. Body weight \> 200 kg. 3. Ongoing AP or diagnosis of AP in previous 30 days. 4. Diagnosis of chronic pancreatitis, one of the following 1. Ductal stricture, calcification and/or atrophy, as seen on CT scan/MRI 2. 5 or more of the 9 EUS criteria used to diagnose CP 5. Known hypersensitivity to Pirfenidone. 6. AST/ALT ≥ 2 times the upper normal limit. 7. Alkaline phosphatase ≥ 1.5 times the upper normal limit. 8. Bilirubin higher than upper normal limit. 9. Moderate to severe heart failure and/or coronary heart disease (New York Heart Association (NYHA) Functional Class III/IV). 10. On home oxygen or home mechanical ventilation. 11. Advanced liver disease or cirrhosis. 12. Paralytic ileus or significant nausea and vomiting preventing administration of full liquid diet. 13. Chronic diarrhea. 14. Immunosuppressive disorder or on immunosuppressive medications. 15. Active or advanced malignancy. 16. Known cancer that is end-stage with ongoing palliative care or for which palliative care is appropriate. 17. Known history of infective hepatitis. 18. Ongoing photosensitivity and rash. 19. Known live vaccines or therapeutic infectious agents within one month of admission. 20. Known pregnancy or lactation at the time of admission. 21. Women of childbearing potential who are not on oral or injectable contraceptives or IUDs, and do not consent to practice abstinence/adequate contraception while on, and for 90 days after the administration of the drug/placebo. 22. Known to be currently participating in a trial testing any investigational medicinal product or participation in a clinical study involving a medicinal product in the last three months. 23. Problematic pattern of alcohol use or moderate to severe alcohol use disorder (Appendix 2) 24. Substance use disorder (except recreational or medicinal use of marijuana) 25. Family or personal history of long QT syndrome ( \> 500 msec). 26. Strong CYP1A2 inhibitors (e.g., fluvoxamine, enoxacin) or moderate CYP1A2 Inhibitors (e.g., ciprofloxacin). 27. Medications like sildenafil. 28. Renal disease with GFR \< 30. 29. Any condition other than above that, in the opinion of the investigator, is likely to result in the death of the patient within the next 2 years. 30. Any condition that, in the opinion of the investigator, might be significantly exacerbated by the known side effects associated with the administration of Pirfenidone.

Inclusion Criteria

Exclusion Criteria

1. Patients 18 - 85 years of age
2. Two or more documented attacks of acute pancreatitis, separated by 3 months from one another, defined by at least 2 of the following 3:
1. amylase or lipase values, or both, that are greater than 3 times the upper limit of normal values
2. characteristic cross-sectional imaging
3. typical upper abdominal pain according to the revised Atlanta classification28
3. Drug/placebo treatment to start
1. Mild AP
* Patient is discharged out of the hospital
* 30 days after diagnosis of mild AP
2. Moderate Severe or Severe AP
* Patient is discharged out of hospital
* Intra-abdominal collections are either resolved on imaging, or are improving and asymptomatic and do not warrant any intervention (per treating physician)
4. Ability to understand and the willingness to sign a written informed consent document and medical release
5. Willing and able to comply with trial protocol and follow up
6. 2nd AP episode despite correction of the AP etiology (if identified) after the 1st episode as follows i. Patients with biliary pancreatitis who have undergone cholecystectomy, with or without ERCP (if indicated) ii. Patients with hypertriglyceridemia induced pancreatitis who have serum triglyceride levels below 250 with medication management iii. Patients with medication induced AP developing a 2nd AP episode despite stopping the culprit medication

1. Age \< 18 or \> 85 years.
2. Body weight \> 200 kg.
3. Ongoing AP or diagnosis of AP in previous 30 days.
4. Diagnosis of chronic pancreatitis, one of the following
1. Ductal stricture, calcification and/or atrophy, as seen on CT scan/MRI
2. 5 or more of the 9 EUS criteria used to diagnose CP
5. Known hypersensitivity to Pirfenidone.
6. AST/ALT ≥ 2 times the upper normal limit.
7. Alkaline phosphatase ≥ 1.5 times the upper normal limit.
8. Bilirubin higher than upper normal limit.
9. Moderate to severe heart failure and/or coronary heart disease (New York Heart Association (NYHA) Functional Class III/IV).
10. On home oxygen or home mechanical ventilation.
11. Advanced liver disease or cirrhosis.
12. Paralytic ileus or significant nausea and vomiting preventing administration of full liquid diet.
13. Chronic diarrhea.
14. Immunosuppressive disorder or on immunosuppressive medications.
15. Active or advanced malignancy.
16. Known cancer that is end-stage with ongoing palliative care or for which palliative care is appropriate.
17. Known history of infective hepatitis.
18. Ongoing photosensitivity and rash.
19. Known live vaccines or therapeutic infectious agents within one month of admission.
20. Known pregnancy or lactation at the time of admission.
21. Women of childbearing potential who are not on oral or injectable contraceptives or IUDs, and do not consent to practice abstinence/adequate contraception while on, and for 90 days after the administration of the drug/placebo.
22. Known to be currently participating in a trial testing any investigational medicinal product or participation in a clinical study involving a medicinal product in the last three months.
23. Problematic pattern of alcohol use or moderate to severe alcohol use disorder (Appendix 2)
24. Substance use disorder (except recreational or medicinal use of marijuana)
25. Family or personal history of long QT syndrome ( \> 500 msec).
26. Strong CYP1A2 inhibitors (e.g., fluvoxamine, enoxacin) or moderate CYP1A2 Inhibitors (e.g., ciprofloxacin).
27. Medications like sildenafil.
28. Renal disease with GFR \< 30.
29. Any condition other than above that, in the opinion of the investigator, is likely to result in the death of the patient within the next 2 years.
30. Any condition that, in the opinion of the investigator, might be significantly exacerbated by the known side effects associated with the administration of Pirfenidone.

Contacts and Locations

Study Contact

Vikas Dudeja, M.B.B.S.

CONTACT

2059343028

vdudeja@uabmc.edu

Santhi Swaroop Vege, M.D.

CONTACT

Study Locations (Sites)

UAB

Birmingham, Alabama, 35294

United States

Collaborators and Investigators

Sponsor: University of Alabama at Birmingham

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-06-27

Study Completion Date2028-02-01

Study Record Updates

Study Start Date2024-06-27

Study Completion Date2028-02-01

Terms related to this study

Additional Relevant MeSH Terms

Recurrent Acute Pancreatitis