Pirfenidone for Acute Pancreatitis
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial is testing pirfenidone, a medication already used for lung disease, to see if it can help patients with severe acute pancreatitis. The goal is to find out if it is safe and if it can reduce inflammation and improve symptoms. Patients will be monitored closely throughout the study.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications, but it excludes those on immunosuppressive medications and certain drugs like fluvoxamine or sildenafil. It's best to discuss your specific medications with the trial team.
Is pirfenidone safe for humans?
Pirfenidone is generally considered safe for humans as it is FDA approved for treating idiopathic pulmonary fibrosis (a lung disease). Studies in mice suggest it may also help with pancreatitis by reducing inflammation and fibrosis (scarring), but more research is needed to confirm its safety and effectiveness for this condition in humans.12345
How does the drug pirfenidone differ from other treatments for acute pancreatitis?
Pirfenidone is unique because it is an anti-inflammatory and anti-fibrotic drug that increases IL-10, a protein that helps reduce inflammation, and is already FDA approved for another condition, idiopathic pulmonary fibrosis. Unlike other treatments, it can be administered even at the peak of injury to reduce the severity of acute pancreatitis by modulating immune responses and decreasing inflammatory cytokines.24678
What data supports the effectiveness of the drug Pirfenidone for treating acute pancreatitis?
Are You a Good Fit for This Trial?
Adults aged 18-85 with moderately severe to severe acute pancreatitis can join this trial. They must be hospitalized and diagnosed within 48 hours, without certain conditions like liver disease, heart failure, or a recent history of alcohol abuse. Pregnant women and those on specific medications are excluded.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive pirfenidone or placebo for 7 days to evaluate safety and tolerability
Follow-up
Participants are monitored for safety and effectiveness after treatment, with weekly phone follow-ups for 4 weeks and monthly for up to 6 months
What Are the Treatments Tested in This Trial?
Interventions
- Pirfenidone
Pirfenidone is already approved in European Union, United States, Canada, Japan, China for the following indications:
- Idiopathic Pulmonary Fibrosis
- Idiopathic Pulmonary Fibrosis
- Idiopathic Pulmonary Fibrosis
- Idiopathic Pulmonary Fibrosis
- Idiopathic Pulmonary Fibrosis
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Alabama at Birmingham
Lead Sponsor
Mayo Clinic
Collaborator