Safety and Tolerability of Pirfenidone in Acute Pancreatitis

Recruiting now · Phase 1/Phase 2 · Has a placebo group

Conditions studied: Pancreatitis, Acute

In brief

The goal of the current pilot clinical trial is to evaluate the safety and tolerability of pirfenidone in patients with predicted moderately severe and severe acute pancreatitis. Pirfenidone is currently approved by FDA for the treatment of idiopathic pulmonary fibrosis. Now, over 5 years of data has accumulated demonstrating safety of its use in humans. The investigators' preclinical data suggest that pirfenidone is very effective in reducing the severity of acute pancreatitis in animal models. Following are the objectives of the proposed clinical trial: Primary Objective: * To evaluate the safety and tolerability of pirfenidone, compared to placebo, in patients predicted to have moderately severe or severe AP. * To evaluate the efficacy of pirfenidone in reducing the laboratory markers of inflammation and improving patient reported outcome measures. Secondary Objective: \- To evaluate the efficacy of pirfenidone in reducing the severity of acute pancreatitis, as measured by well-defined endpoints.

Key facts

Study ID: NCT05350371
Run by: University of Alabama at Birmingham
People needed: 60
Starts: 2023-08-01
Expected to finish: 2027-02-01
Last updated by the study team: 2025-08-01

Who can join

Age: 18 and older, up to 85. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Patients 18 - 85 years of age
Admitted to hospital for AP, defined by at least 2 of the following 3:
amylase or lipase values, or both, that are greater than 3 times the upper limit of normal values
characteristic cross-sectional imaging
typical upper abdominal pain- acute onset of a persistent, severe, epigastric pain often radiating to the back
Patients identified, approached, and consented to administer study medication or placebo within 48 hours of diagnosis of AP.
Predicted to have MSAP or SAP by presence of one or more of the following criteria
APACHE II ≥ 8
Modified Glasgow or Imrie score ≥ 3
CRP > 150 mg/dL
PASS score > 140 at or within 48 hrs. of admission
CT or MRI imaging suggesting pancreatic and/or peri-pancreatic necrosis

You may not qualify if…

Age < 18 or > 85 years
Body weight > 200 kg
Presentation to the medical attention > 48 h after diagnosis of AP
Inability to recruit, randomize and start the allocated treatment within 48h of start of pain
Ongoing AP or diagnosis of AP in previous 30 days
Chronic pancreatitis
Known hypersensitivity to pirfenidone
AST/ALT ≥ 2 times the upper normal limit.
Alkaline phosphatase ≥ 2 times the upper normal limit
Bilirubin higher than upper normal limit
Moderate to severe heart failure and/or coronary heart disease (New York Heart Association (NYHA) Functional Class III/IV)
On home oxygen or home mechanical ventilation
Advanced liver disease
Paralytic ileus or significant nausea and vomiting
Chronic Diarrhea
Immunosuppressive disorder or on immunosuppressive medications
Active or advanced malignancy
Known cancer that is end-stage with ongoing palliative care or for which palliative care is appropriate
Known established infection prior to the onset of acute pancreatitis
Known history of infective hepatitis
Known live vaccines or therapeutic infectious agents within one month of admission
Known pregnancy or lactation at the time of admission
Ongoing photosensitivity and rash
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.
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

Where it is running

UAB — Birmingham, Alabama, United States (enrolling)
Mayo Clinic — Rochester, Minnesota, United States

Full record on ClinicalTrials.gov

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