Pirfenidone increases IL-10 and improves acute pancreatitis in multiple clinically relevant murine models.
Ejas Palathingal Bava, John George, Mohammad Tarique...
https://pubmed.ncbi.nlm.nih.gov/34847076Actively Recruiting
Phase 1
Phase 2
Age: 18Years - 85Years
All Genders
ID05350371
Evaluation of Pirfenidone as a Therapy in Patients With Predicted Moderate to Severe Acute Pancreatitis
Led by University of Alabama at Birmingham · Updated on 2025-08-01
60
Participants Needed
2
Research Sites
52 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
Researchers are evaluating the safety and tolerability of pirfenidone in patients with predicted moderately severe to severe acute pancreatitis. This pilot clinical trial also aims to assess the drug's effectiveness in reducing inflammation markers and improving patient-reported outcomes. The study is randomized and includes secondary endpoints measuring the severity of acute pancreatitis with well-defined clinical markers. Participants will be randomly assigned to receive either pirfenidone or a placebo. Those in the pirfenidone group will take oral tablets starting with 267 mg three times a day for one day, followed by two tablets three times a day for six days, totaling seven days of treatment or until an adverse event occurs. Patients are screened within 48 hours of diagnosis and followed daily while hospitalized. After discharge, follow-up occurs weekly by phone for four weeks and then monthly for up to six months. During the study, participants will undergo daily monitoring in the hospital and regular telephone check-ins after discharge to track safety and treatment effects. Researchers will measure serious adverse events over six months, treatment completion rates over seven days, changes in inflammatory markers like C-reactive protein and cytokines over seven days, and patient-reported symptom scores at specific time points. Secondary outcomes include severity scores during admission, readmission rates, and emergency visits within six months.
CONDITIONS
Brief Title
Safety and Tolerability of Pirfenidone in Acute Pancreatitis
Who Can Participate
Age: 18Years - 85Years
All Genders
Eligibility Criteria
You may qualify if you...
- Patients aged 18 to 85 years
- Hospitalized for acute pancreatitis diagnosed by at least two of: elevated amylase or lipase >3 times normal, characteristic imaging, or typical severe upper abdominal pain
- Able to receive study medication within 48 hours of acute pancreatitis diagnosis
- Predicted moderately severe or severe acute pancreatitis by one or more criteria: APACHE II ≥ 8, Modified Glasgow or Imrie score ≥ 3, CRP > 150 mg/dL, PASS score > 140 within 48 hours of admission, or imaging suggesting pancreatic necrosis
You will not qualify if you...
- Age under 18 or over 85 years
- Body weight over 200 kg
- Presentation for medical attention more than 48 hours after diagnosis
- Unable to start treatment within 48 hours of pain onset
- Ongoing or recent acute pancreatitis within 30 days
- Chronic pancreatitis
- Known allergy to pirfenidone
- Liver function tests (AST/ALT, alkaline phosphatase, bilirubin) elevated beyond twice the normal limit or upper normal limit
- 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, significant nausea, vomiting, or chronic diarrhea
- Immunosuppressive disorders or medications
- Active or advanced cancer or end-stage cancer under palliative care
- Known infections prior to acute pancreatitis onset
- Recent live vaccines or therapeutic infectious agents within one month
- Pregnancy or breastfeeding
- Photosensitivity, rash, or refusal to use contraception if of childbearing potential
- Participation in other investigational drug trials within three months
- Alcohol or substance abuse in past two years
- Family or personal history of long QT syndrome
- Use of medications like fluvoxamine or sildenafil
- Significant photosensitivity or new rash
- Severe kidney disease (GFR < 30)
- Any condition likely to cause death within two years or worsened by pirfenidone side effects
AI-Screening
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Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - Up to 48 hours from diagnosis
Participants are screened for eligibility to participate in the trial.
1 screening and enrollment visit (in-person)
Treatment
Duration - Up to 7 days or until treatment discontinuation due to adverse events
Participants receive pirfenidone or placebo treatment while hospitalized to evaluate safety and tolerability.
Daily in-person visits during hospitalization
Follow-up
Duration - Weekly for 4 weeks, then monthly for up to 6 months
Participants are followed after hospital discharge to monitor safety and study outcomes.
Weekly telephone visits for 4 weeks, then monthly telephone visits up to 6 months
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
M
Mustafa AL-Oabidi, MD
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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Published Research Related To This Trial
Safety, tolerability and therapeutic efficacy of anti-inflammatory drug pirfenidone in acute pancreatitis patients: Protocol for a randomized pilot clinical trial.
Ejas P Bava, Tejeshwar Jain, Mustafa Al-Obaidi...
https://pubmed.ncbi.nlm.nih.gov/39864969