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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 months
Awards & highlights
Study Summary
This trial will test if pirfenidone, already approved to treat idiopathic pulmonary fibrosis, is safe and effective in reducing the severity of acute pancreatitis.
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.Check my eligibility
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.See study design
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 belowSelect...
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.
Select...
I agreed to start the study treatment within 2 days of being diagnosed with AP.
Select...
I am between 18 and 85 years old.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 6 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
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 moreSecondary outcome measures
Composition outcome
PASS score at the time of discharge
Readmission and/or ER visits
+2 moreTrial 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
Find a Location
Who is running the clinical trial?
University of Alabama at BirminghamLead Sponsor
1,590 Previous Clinical Trials
2,281,422 Total Patients Enrolled
Mayo ClinicOTHER
3,213 Previous Clinical Trials
3,766,951 Total Patients Enrolled
3 Trials studying Acute Pancreatitis
113 Patients Enrolled for Acute Pancreatitis
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- 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.I have severe heart issues classified as NYHA Class III or IV.My liver disease is in an advanced stage.My condition is end-stage cancer, and I am receiving or suitable for palliative care.I had an infection before my acute pancreatitis started.I have a history of hepatitis infection.My pancreatitis is severe, based on tests and scans done within 48 hours of my hospital admission.I or my family have a history of long QT syndrome.I am currently taking medications such as fluvoxamine or sildenafil.I currently have a rash and sensitivity to light.I cannot start treatment within 48 hours of my pain starting.I don't have conditions that could worsen from pirfenidone side effects.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.I have not received any live vaccines or infectious treatments in the last month.I have chronic pancreatitis.I have long-term diarrhea.I have severe nausea or a paralyzed intestine.I need oxygen or a ventilator at home.My kidney function is low, with a GFR under 30.I am younger than 18 or older than 85.I am between 18 and 85 years old.My cancer is in an advanced stage.I have an immune system disorder or am taking medication that weakens my immune system.
Research Study Groups:
This trial has the following groups:- Group 1: Placebo
- Group 2: Pirfenidone Treatment
Awards:
This trial has 2 awards, including:- 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.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are participants currently being sought for this examination?
"Yes, indeed. According to the clinicaltrials.gov webpage, this medical research project that was posted on August 1st 2023 is currently recruiting patients from two different sites and needs 60 volunteers in total."
Answered by AI
To what capacity is this research project accommodating participants?
"Affirmative. Based on the information available from clinicaltrials.gov, this research is actively recruiting subjects to partake in their experiment. The trial was posted on August 1st 2023 and last updated 28 days later; they are seeking 60 participants across 2 medical centres."
Answered by AI
Could individuals aged 50 and older enroll in this research project?
"In order to meet the qualifications for participation, individuals must be aged 18 to 85 years old."
Answered by AI
Can I join this investigation?
"This clinical trial requires participants with acute pancreatitis between the ages of 18 and 85 years old. In total, 60 individuals are needed to complete this research."
Answered by AI
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