What side effects are associated with this type of intervention?

Pirfenidone, an anti-fibrotic and anti-inflammatory drug being studied for acute pancreatitis, is known to cause side effects such as nausea, rash, fatigue, diarrhea, and liver enzyme abnormalities. These side effects are consistent with its use in treating idiopathic pulmonary fibrosis. Broadly, treatments for acute pancreatitis can include supportive care, pain management, and addressing the underlying cause, each with its own side effect profile.

What prior FDA approvals exist?

Currently, there are no FDA-approved treatments specifically for acute pancreatitis that have anti-fibrotic and anti-inflammatory effects similar to pirfenidone. Pirfenidone itself is approved for idiopathic pulmonary fibrosis due to its anti-fibrotic properties, but its use in acute pancreatitis is still under investigation. The focus of current treatments for acute pancreatitis is primarily supportive care, including fluid resuscitation, pain management, and nutritional support.

What other types of research exist?

Nintedanib is a promising alternative to Pirfenidone for its anti-fibrotic effects. It has been shown to slow disease progression in various fibrosing lung diseases, including IPF. Additionally, Tacrolimus, which has shown survival benefits in acute exacerbations of IPF, may also be considered for its immunosuppressive and anti-inflammatory properties. Further clinical trials would be necessary to confirm their efficacy and safety in acute pancreatitis.

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Anti-fibrotic agent

Pirfenidone for Acute Pancreatitis

Phase 1 & 2

Recruiting

Research Sponsored by University of Alabama at Birmingham

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Predicted to have moderately severe acute pancreatitis (MSAP) or severe acute pancreatitis (SAP) by meeting one or more of the following criteria: APACHE II score ≥ 8, Modified Glasgow or Imrie score ≥ 3, CRP > 150 mg/dL, PASS score > 140 at or within 48 hours of admission, CT or MRI imaging suggesting pancreatic and/or peri-pancreatic necrosis

Admitted to hospital for acute pancreatitis (AP) defined by at least 2 of the following 3 criteria: amylase or lipase values greater than 3 times the upper limit of normal values, characteristic cross-sectional imaging, typical upper abdominal pain with acute onset of persistent, severe, epigastric pain often radiating to the back

Must not have

Moderate to severe heart failure and/or coronary heart disease (New York Heart Association (NYHA) Functional Class III/IV)

Advanced liver disease

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6 months

Awards & highlights

All Individual Drugs Already Approved

Approved for 5 Other Conditions

Summary

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.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

While not specified here, Pirfenidone's known side effects include fatigue, nausea, rash or photosensitivity (sensitivity to light), digestive issues, and potential liver problems.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My pancreatitis is severe, based on tests and scans done within 48 hours of my hospital admission.

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I was hospitalized for severe upper stomach pain and my tests show high enzyme levels or imaging confirmed pancreatitis.

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I agreed to start the study treatment within 2 days of being diagnosed with AP.

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I am between 18 and 85 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have severe heart issues classified as NYHA Class III or IV.

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My liver disease is in an advanced stage.

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My condition is end-stage cancer, and I am receiving or suitable for palliative care.

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I had an infection before my acute pancreatitis started.

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I have a history of hepatitis infection.

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I or my family have a history of long QT syndrome.

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I currently have a rash and sensitivity to light.

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I have chronic pancreatitis.

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I have long-term diarrhea.

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I have severe nausea or a paralyzed intestine.

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I need oxygen or a ventilator at home.

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My kidney function is low, with a GFR under 30.

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I am younger than 18 or older than 85.

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My cancer is in an advanced stage.

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I have an immune system disorder or am taking medication that weakens my immune system.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~6 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Changes in C-reactive protein (CRP), TNF-α, interleukin (IL)-6, IL-8 and IL-10 levels

Development of anticipated or un-anticipated serious adverse events (class 3 or 4)

percentage of patients having decrease in PAN-PROMISE score by at least 10 points at 72h after initiation of the drug

+1 more

Secondary study objectives

Composition outcome

PASS score at the time of discharge

cumulative PAN-PROMISE score

+1 more

Awards & Highlights

All Individual Drugs Already Approved

Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

Approved for 5 Other Conditions

This treatment demonstrated efficacy for 5 other conditions.

Trial Design

2Treatment groups

Experimental Treatment

Group I: PlaceboExperimental Treatment1 Intervention

Group II: Pirfenidone TreatmentExperimental Treatment1 Intervention

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Placebo

1995

Completed Phase 3

~2670

0 / 19Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for Acute Pancreatitis focus on reducing inflammation and preventing fibrosis, which are key contributors to the disease's severity. Anti-inflammatory agents, such as corticosteroids, work by suppressing the immune response and reducing the release of pro-inflammatory cytokines, thereby alleviating inflammation and tissue damage. Anti-fibrotic agents, like Pirfenidone, inhibit the pathways that lead to fibrosis, preventing the excessive deposition of extracellular matrix proteins that can lead to organ dysfunction. These mechanisms are crucial for Acute Pancreatitis patients as they help to mitigate the acute inflammatory response and prevent long-term complications associated with fibrosis, ultimately improving patient outcomes.