60 Participants Needed

Pirfenidone for Acute Pancreatitis

VD
MA
Overseen ByMustafa AL-Oabidi, MD
Age: 18+
Sex: Any
Trial Phase: Phase 1 & 2
Sponsor: University of Alabama at Birmingham
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Breakthrough TherapyThis drug has been fast-tracked for approval by the FDA given its high promise
Approved in 6 JurisdictionsThis treatment is already approved in other countries

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?

Research in mice shows that Pirfenidone, a drug approved for lung disease, can reduce inflammation and injury in acute pancreatitis by increasing IL-10, a helpful immune molecule, and changing how immune cells behave.24569

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

My pancreatitis is severe, based on tests and scans done within 48 hours of my hospital admission.
I was hospitalized for severe upper stomach pain and my tests show high enzyme levels or imaging confirmed pancreatitis.
I agreed to start the study treatment within 2 days of being diagnosed with AP.

Exclusion Criteria

Women of childbearing potential not on contraceptives or IUDs and not consenting to abstinence for 4 weeks
I have had acute pancreatitis in the last 30 days or it is ongoing.
I sought medical help more than 48 hours after being diagnosed with acute pancreatitis.
See 27 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 days
1 visit (in-person)

Treatment

Participants receive pirfenidone or placebo for 7 days to evaluate safety and tolerability

7 days
Daily visits (in-person) while in hospital

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

6 months
Weekly phone follow-ups for 4 weeks, then monthly for up to 6 months

What Are the Treatments Tested in This Trial?

Interventions

  • Pirfenidone
Trial Overview The trial is testing the safety and effectiveness of Pirfenidone—an FDA-approved drug for lung fibrosis—against a placebo in reducing inflammation in acute pancreatitis patients. Participants will report their outcomes as part of the study.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Group I: PlaceboExperimental Treatment1 Intervention
Group II: Pirfenidone TreatmentExperimental Treatment1 Intervention

Pirfenidone is already approved in European Union, United States, Canada, Japan, China for the following indications:

🇪🇺
Approved in European Union as Esbriet for:
  • Idiopathic Pulmonary Fibrosis
🇺🇸
Approved in United States as Esbriet for:
  • Idiopathic Pulmonary Fibrosis
🇨🇦
Approved in Canada as Esbriet for:
  • Idiopathic Pulmonary Fibrosis
🇯🇵
Approved in Japan as Pirespa for:
  • Idiopathic Pulmonary Fibrosis
🇨🇳
Approved in China as Etuary for:
  • Idiopathic Pulmonary Fibrosis

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Alabama at Birmingham

Lead Sponsor

Trials
1,677
Recruited
2,458,000+

Mayo Clinic

Collaborator

Trials
3,427
Recruited
3,221,000+

Published Research Related to This Trial

Pirfenidone, an FDA-approved drug for idiopathic pulmonary fibrosis, shows promise in reducing the severity of acute pancreatitis (AP) by decreasing local and systemic injury and inflammation, even when administered at the peak of injury.
The drug works by increasing IL-10 secretion from macrophages and modulating the immune response, as confirmed by experiments that demonstrated its efficacy relies on the presence of IL-10 and macrophages.
Pirfenidone increases IL-10 and improves acute pancreatitis in multiple clinically relevant murine models.Palathingal Bava, E., George, J., Tarique, M., et al.[2022]
Pirfenidone, an FDA-approved drug for Idiopathic Pulmonary Fibrosis, has shown promising results in mouse models of chronic pancreatitis (CP) by reducing fibrosis, inflammation, and pancreatic damage, indicating its potential as a new treatment option for CP.
The drug's efficacy appears to be linked to its ability to reduce macrophage infiltration and alter cytokine levels in the pancreas, suggesting that targeting macrophages may be a key mechanism in its therapeutic action.
Pirfenidone ameliorates chronic pancreatitis in mouse models through immune and cytokine modulation.Palathingal Bava, E., George, J., Iyer, S., et al.[2022]
New drugs like somatostatin, octreotide, and loxiglumide have been tested to reduce pancreatic secretion in severe acute pancreatitis, but the mortality rate remains high despite these efforts.
The anti-inflammatory agent IS-741 has shown promise in experimental models of pancreatitis, indicating potential for future clinical applications in managing this condition.
[New aspects of pharmaco-therapy for acute pancreatitis].Takase, K., Ueda, T., Kuroda, Y.[2017]

Citations

Pirfenidone increases IL-10 and improves acute pancreatitis in multiple clinically relevant murine models. [2022]
Pirfenidone ameliorates chronic pancreatitis in mouse models through immune and cytokine modulation. [2022]
[New aspects of pharmaco-therapy for acute pancreatitis]. [2017]
Lung injury in the microembolic model of acute pancreatitis and amelioration by lexipafant (BB-882), a platelet-activating factor antagonist. [2019]
A single center randomized double blind controlled trial of pentoxifylline in acute pancreatitis: Challenges and opportunities. [2021]
Incretin-mimetic therapies and pancreatic disease: a review of observational data. [2022]
A prospective, claims-based assessment of the risk of pancreatitis and pancreatic cancer with liraglutide compared to other antidiabetic drugs. [2021]
Cystic fibrosis transmembrane conductance regulator modulators reduce the risk of recurrent acute pancreatitis among adult patients with pancreas sufficient cystic fibrosis. [2020]
Inhibition of renin-angiotensin system in experimental acute pancreatitis in rats: a new therapeutic target? [2022]
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