Actively Recruiting
Evaluation of Pirfenidone as a Novel Therapeutic Strategy Against Recurrent Acute Pancreatitis.
Led by University of Alabama at Birmingham · Updated on 2025-10-14
60
Participants Needed
2
Research Sites
218 weeks
Total Duration
On this page
Sponsors
U
University of Alabama at Birmingham
Lead Sponsor
C
Congressionally Directed Medical Research Programs
Collaborating Sponsor
AI-Summary
What this Trial Is About
This clinical will evaluate the safety, tolerability and early efficacy of pirenidone in patients with recurrent acute pancreatitis.
CONDITIONS
Official Title
Evaluation of Pirfenidone as a Novel Therapeutic Strategy Against Recurrent Acute Pancreatitis.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients aged 18 to 85 years
- Two or more documented attacks of acute pancreatitis separated by at least 3 months, defined by at least two of the following: amylase or lipase levels greater than 3 times normal, characteristic imaging, or typical upper abdominal pain
- For mild acute pancreatitis, discharged from hospital at least 30 days after diagnosis
- For moderate to severe acute pancreatitis, discharged with resolved or improving intra-abdominal collections and minimal symptoms
- Ability to understand and sign informed consent and medical release
- Willingness and ability to comply with study protocol and follow-up
- Second episode of acute pancreatitis despite correction of known causes such as cholecystectomy for biliary pancreatitis, controlled triglyceride levels for hypertriglyceridemia, or stopping causative medication for medication-induced pancreatitis
You will not qualify if you...
- Age under 18 or over 85 years
- Body weight over 200 kg
- Ongoing acute pancreatitis or diagnosis within the past 30 days with significant symptoms
- Diagnosis of chronic pancreatitis based on imaging or endoscopic ultrasound criteria
- Known allergy or hypersensitivity to pirfenidone
- Liver enzyme levels (AST/ALT) more than 3 times normal
- Alkaline phosphatase more than 2.5 times normal
- Elevated bilirubin above normal
- Moderate to severe heart failure or coronary heart disease (NYHA Class III/IV)
- Use of home oxygen or mechanical ventilation
- Advanced liver disease (Child-Pugh class B or C cirrhosis)
- Paralytic ileus or severe nausea/vomiting preventing light diet
- Chronic diarrhea lasting more than 6 months not consistent with steatorrhea
- Active cancer treatment or cancer-free less than 3 years except non-melanoma skin cancer
- End-stage cancer with palliative care
- History of infectious hepatitis unless cured
- Current photosensitivity or rash
- Recent live vaccines or infectious agents within one month
- Pregnancy or lactation
- Women of childbearing potential not using effective contraception
- Participation in another investigational drug study within the last 3 months
- Problematic alcohol or substance use disorders
- Family or personal history of long QT syndrome
- Use of strong or moderate CYP1A2 inhibitors
- Severe kidney disease with GFR below 30
- Any condition likely to cause death within 2 years or worsen with pirfenidone, as judged by investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 2 locations
1
UAB
Birmingham, Alabama, United States, 35294
Actively Recruiting
2
Mayo Clinic
Rochester, Minnesota, United States, 55905
Actively Recruiting
Research Team
K
kondal Kyanam, M.B.B.S.
CONTACT
S
Santhi Swaroop Vege, M.D.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here