RecruitingPhase 1Phase 2NCT05350371

Safety and Tolerability of Pirfenidone in Acute Pancreatitis

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

Sponsor

University of Alabama at Birmingham

Enrollment

60 participants

Start Date

Aug 1, 2023

Study Type

INTERVENTIONAL

Conditions

Pancreatitis, Acute

Summary

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.

Eligibility

Min Age: 18 YearsMax Age: 85 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether pirfenidone — a medication approved for lung fibrosis — can reduce complications and scarring (fibrosis) in patients who are hospitalized with moderate to severe acute pancreatitis (sudden, severe inflammation of the pancreas). The drug is taken as a pill and may prevent the organ damage that can follow a severe episode. You may be eligible if... - You are 18 to 85 years old - You have been admitted to the hospital with acute pancreatitis confirmed by at least 2 of 3 standard criteria - You are predicted to have moderate to severe pancreatitis based on clinical scoring - You were approached within 48 hours of your pancreatitis diagnosis You may NOT be eligible if... - You have a prior episode of pancreatitis within the past 30 days, or chronic pancreatitis - You have an allergy to pirfenidone - You have significant liver, heart, or kidney problems - You are pregnant or breastfeeding - You have active cancer, immunosuppression, or a long-term infection like hepatitis - You have a history of long QT syndrome or are taking interacting medications (like fluvoxamine) - You have alcohol or substance abuse in the past 2 years Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGPirfenidone Oral Tablet

Patients in the pirfenidone treatment arm will be given pirfenidone 267mg tablet, tid for 1 day followed by dose escalation to two 267 mg tablet tid for 6 days. Thus, the treatment will be for total of 7 days or till patients develop an adverse event that requires their participation in the study to be stopped.

DRUGPlacebo

The placebo tablets will be an exact replica of the pirfenidone tablet.