NCT05350371 · University of Alabama at Birmingham
Safety and Tolerability of Pirfenidone in Acute Pancreatitis
What this study is about
The goal of the current pilot clinical trial is to evaluate the safety and how well patients handle the treatment of pirfenidone in patients with predicted moderately severe and severe acute pancreatitis. Pirfenidone is currently approved by FDA for the treatment of idiopathic pulmonary fibrosis. Now, over 5 years of data has accumulated demonstrating safety of its use in humans.
View original scientific description
The goal of the current pilot clinical trial is to evaluate the safety and tolerability of pirfenidone in patients with predicted moderately severe and severe acute pancreatitis. Pirfenidone is currently approved by FDA for the treatment of idiopathic pulmonary fibrosis. Now, over 5 years of data has accumulated demonstrating safety of its use in humans. The investigators' preclinical data suggest that pirfenidone is very effective in reducing the severity of acute pancreatitis in animal models.
Interventions
DRUG
Pirfenidone Oral Tablet
Patients in the pirfenidone treatment arm will be given pirfenidone 267mg tablet, tid for 1 day followed by dose escalation to two 267 mg tablet tid for 6 days. Thus, the treatment will be for total of 7 days or till patients develop an adverse event that requires their participation in the study to be stopped.
DRUG
Placebo
The placebo tablets will be an exact replica of the pirfenidone tablet.
Primary outcome measures
Development of anticipated or un-anticipated serious adverse events (class 3 or 4)
Time frame: 6 months
Development of anticipated or un-anticipated serious adverse events (class 3 or 4)
percentage of patients starting and completion of the planned drug treatment
Time frame: 7 days
percentage of patients starting and completion of the planned drug treatment
Changes in C-reactive protein (CRP), TNF-α, interleukin (IL)-6, IL-8 and IL-10 levels
Time frame: 7 days
Compared to base line
percentage of patients having decrease in PAN-PROMISE score by at least 10 points at 72h after initiation of the drug
Time frame: 3 days
Measurement of PAN-PROMISE score
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Patients 18 - 85 years of age 2. Admitted to hospital for AP, defined by at least 2 of the following 3: 1. amylase or lipase values, or both, that are greater than 3 times the upper limit of normal values 2. characteristic cross-sectional imaging 3. typical upper abdominal pain- acute onset of a persistent, severe, epigastric pain often radiating to the back 3. Patients identified, approached, and consented to administer study medication or placebo within 48 hours of diagnosis of AP. 4. Predicted to have MSAP or SAP by presence of one or more of the following criteria 1. APACHE II ≥ 8 2. Modified Glasgow or Imrie score ≥ 3 3. CRP \> 150 mg/dL 4. PASS score \> 140 at or within 48 hrs. of admission 5. CT or MRI imaging suggesting pancreatic and/or peri-pancreatic necrosis
Exclusion criteria
- Age \< 18 or \> 85 years 2. Body weight \> 200 kg 3. Presentation to the medical attention \> 48 h after diagnosis of AP 4. Inability to recruit
Where
- Birmingham, Alabama
- Rochester, Minnesota
Collaborators
Mayo Clinic
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Aug 1, 2025 · Source of record for eligibility and locations