Evaluating the safety of pirfenidone for treating acute pancreatitis

Evaluation of Pirfenidone as a Therapy in Patients With Predicted Moderate to Severe Acute Pancreatitis

This study is testing if the drug pirfenidone is safe for people with moderately severe to severe acute pancreatitis and if it can help reduce inflammation and improve their recovery.

Quick facts

• Phase: Phase1; Phase2
• Study type: Interventional
• Enrollment: 60 (estimated)
• Ages: 18 Years to 85 Years
• Sex: All
• Sponsor: University of Alabama at Birmingham (Academic / other)
• Locations: 2 sites (Birmingham, Alabama and 1 other locations)
• Trial ID: NCT05350371 on ClinicalTrials.gov

What this trial studies

This pilot clinical trial aims to assess the safety and tolerability of pirfenidone in patients diagnosed with moderately severe to severe acute pancreatitis. Participants will be randomized to receive either pirfenidone or a placebo within 48 hours of diagnosis and will be monitored closely during their hospital stay and through follow-up calls for up to six months. The study will also evaluate the drug's efficacy in reducing inflammation and improving patient-reported outcomes. The trial is designed to gather preliminary data that could support further research into pirfenidone's therapeutic potential for this condition.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 85 who are hospitalized with a diagnosis of moderately severe or severe acute pancreatitis.

Not a fit: Patients under 18 or over 85 years old, or those who present more than 48 hours after diagnosis, may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new therapeutic option for patients suffering from acute pancreatitis.

How similar studies have performed: While pirfenidone is already approved for other conditions, this specific application in acute pancreatitis is novel and has not been extensively tested in prior studies.

Eligibility criteria

Inclusion Criteria:

1. Patients 18 - 85 years of age
2. Admitted to hospital for AP, 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- acute onset of a persistent, severe, epigastric pain often radiating to the back
3. Patients identified, approached, and consented to administer study medication or placebo within 48 hours of diagnosis of AP.
4. Predicted to have MSAP or SAP by presence of one or more of the following criteria

   1. APACHE II ≥ 8
   2. Modified Glasgow or Imrie score ≥ 3
   3. CRP \> 150 mg/dL
   4. PASS score \> 140 at or within 48 hrs. of admission
   5. CT or MRI imaging suggesting pancreatic and/or peri-pancreatic necrosis

Exclusion Criteria:

1. Age \< 18 or \> 85 years
2. Body weight \> 200 kg
3. Presentation to the medical attention \> 48 h after diagnosis of AP
4. Inability to recruit, randomize and start the allocated treatment within 48h of start of pain
5. Ongoing AP or diagnosis of AP in previous 30 days
6. Chronic pancreatitis
7. Known hypersensitivity to pirfenidone
8. AST/ALT ≥ 2 times the upper normal limit.
9. Alkaline phosphatase ≥ 2 times the upper normal limit
10. Bilirubin higher than upper normal limit
11. Moderate to severe heart failure and/or coronary heart disease (New York Heart Association (NYHA) Functional Class III/IV)
12. On home oxygen or home mechanical ventilation
13. Advanced liver disease
14. Paralytic ileus or significant nausea and vomiting
15. Chronic Diarrhea
16. Immunosuppressive disorder or on immunosuppressive medications
17. Active or advanced malignancy
18. Known cancer that is end-stage with ongoing palliative care or for which palliative care is appropriate
19. Known established infection prior to the onset of acute pancreatitis
20. Known history of infective hepatitis
21. Known live vaccines or therapeutic infectious agents within one month of admission
22. Known pregnancy or lactation at the time of admission
23. Ongoing photosensitivity and rash
24. Women of childbearing potential who are not on oral or injectable contraceptives or IUDs and do not consent to practice abstinence for period of 4 weeks.
25. 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
26. Alcohol or substance abuse in the past 2 years
27. Family or personal history of long QT syndrome ( \> 500 msec)
28. Medications like fluvoxamine or sildanefil
29. Significant photosensitivity or new rash
30. Renal disease with GFR \< 30
31. 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
32. Any condition that, in the opinion of the investigator, might be significantly exacerbated by the known side effects associated with the administration of pirfenidone

Where this trial is running

Birmingham, Alabama and 1 other locations

• UAB — Birmingham, Alabama, United States (Recruiting)
• Mayo Clinic — Rochester, Minnesota, United States (Withdrawn)

Study contacts

• Study coordinator: Vikas Dudeja, MD

Conditions Pancreatitis, Acute