Actively Recruiting

Phase 1
Phase 2
Age: 18Years - 85Years
All Genders
NCT05350371

Safety and Tolerability of Pirfenidone in Acute Pancreatitis

Led by University of Alabama at Birmingham · Updated on 2025-08-01

60

Participants Needed

2

Research Sites

182 weeks

Total Duration

On this page

Sponsors

U

University of Alabama at Birmingham

Lead Sponsor

M

Mayo Clinic

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Safety and Tolerability of Pirfenidone in Acute Pancreatitis

Who Can Participate

Age: 18Years - 85Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients aged 18 to 85 years
  • Hospital admission for acute pancreatitis defined by at least two of: elevated amylase or lipase (greater than 3 times normal), characteristic imaging, or typical severe upper abdominal pain
  • Consent to receive study medication within 48 hours of acute pancreatitis diagnosis
  • Predicted moderately severe or severe acute pancreatitis by one or more of: APACHE II score ≥ 8, Modified Glasgow or Imrie score ≥ 3, CRP > 150 mg/dL, PASS score > 140 within 48 hours of admission, or imaging showing pancreatic/peri-pancreatic necrosis
Not Eligible

You will not qualify if you...

  • Age younger than 18 or older than 85 years
  • Body weight over 200 kg
  • Presentation for medical care more than 48 hours after acute pancreatitis diagnosis
  • Inability to start assigned treatment within 48 hours of pain onset
  • Ongoing acute pancreatitis or diagnosis within previous 30 days
  • Chronic pancreatitis
  • Known allergy to pirfenidone
  • Elevated liver enzymes (AST/ALT ≥ 2 times normal), alkaline phosphatase ≥ 2 times normal, or high bilirubin
  • Moderate to severe heart failure or coronary heart disease (NYHA Class III/IV)
  • Use of home oxygen or mechanical ventilation
  • Advanced liver disease
  • Paralytic ileus or significant nausea and vomiting
  • Chronic diarrhea
  • Immunosuppressive disorders or medications
  • Active or advanced cancer, or receiving palliative care
  • Known infection before acute pancreatitis onset
  • History of infective hepatitis
  • Live vaccines or infectious agents within one month before admission
  • Pregnancy or lactation at admission
  • Ongoing photosensitivity or rash
  • Women of childbearing potential not using effective contraception or abstinence for 4 weeks
  • Participation in another investigational drug trial within last 3 months
  • Alcohol or substance abuse in past 2 years
  • Family or personal history of long QT syndrome
  • Use of medications like fluvoxamine or sildenafil
  • Significant photosensitivity or new rash
  • Renal disease with GFR less than 30
  • Any condition likely to cause death within 2 years or worsen with pirfenidone treatment in investigator's opinion

AI-Screening

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Trial Site Locations

Total: 2 locations

1

UAB

Birmingham, Alabama, United States, 35294

Actively Recruiting

2

Mayo Clinic

Rochester, Minnesota, United States, 55905

Withdrawn

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Research Team

V

Vikas Dudeja, MD

CONTACT

M

Mustafa AL-Oabidi, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

QUADRUPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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