NCT06253117 · University of Alabama at Birmingham
Evaluation of Pirfenidone as a Novel Therapeutic Strategy Against Recurrent Acute Pancreatitis.
(PirfenidoneRAP)
What this study is about
This clinical will evaluate the safety, tolerability and early effectiveness of pirenidone in patients with recurrent acute pancreatitis.
View original scientific description
This clinical will evaluate the safety, tolerability and early efficacy of pirenidone in patients with recurrent acute pancreatitis.
Interventions
DRUG
Pirfenidone
Pirfenidone Days 1-7: 267 mg PO TID (801 mg/day) Days 8-14: 534 mg PO TID (1602 mg/day) Day 15 and thereafter: 801 mg PO TID; not to exceed 2403 mg/day Duration of treatment- total 6 months
DRUG
Placebo
Placebo
Primary outcome measures
Adverse Event
Time frame: 6 months
Development of anticipated or un-anticipated serious adverse events (class 3-4)
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. Two or more documented attacks of acute pancreatitis, separated by 3 months from one another, 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 according to the revised Atlanta classification28 3. Drug/placebo treatment to start 1. Mild AP
- Patient is discharged out of the hospital
- 30 days after diagnosis of mild AP 2. Moderate Severe or Severe AP
- Patient is discharged out of hospital
- Intra-abdominal collections are either resolved on imaging, or are improving and asymptomatic and do not warrant any intervention (per treating physician) 4. Ability to understand and the willingness to sign a written informed consent document and medical release 5. Willing and able to comply with trial protocol and follow up 6. 2nd AP
Where
- Birmingham, Alabama
- Rochester, Minnesota
Collaborators
Congressionally Directed Medical Research Programs
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 Oct 14, 2025 · Source of record for eligibility and locations