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Study identifier: NCT05350371 Synced from ClinicalTrials.gov · July 29, 2026
● Recruiting

Safety and Tolerability of Pirfenidone in Acute Pancreatitis

Condition: Pancreatitis, Acute  ·  Sponsor: University of Alabama at Birmingham

PhasePhase 1/Phase 2
Planned participants60
Who can joinAll sexes, 18 Years to 85 Years
Healthy volunteersNo

About this study

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.

This description comes directly from the study's public registry record.

Talk to the study team

Vikas Dudeja, MD  ·  205 975 7836  ·  vdudeja@uabmc.edu

Mustafa AL-Oabidi, MD  ·  2054139974  ·  malobaidi@uabmc.edu

Always discuss trial participation with your own doctor first.

Locations (2)

UABBirmingham, Alabama, United StatesRecruiting
Mayo ClinicRochester, Minnesota, United StatesWithdrawn

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Source record: clinicaltrials.gov/study/NCT05350371