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
N/A
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
Recurrent Acute Pancreatitis (RAP) involves two or more separate episodes of acute pancreatitis, causing significant health issues and lowering quality of life. Patients with RAP face a high risk of developing chronic pancreatitis (CP). Currently, no treatments exist to prevent future pancreatitis attacks in RAP patients. Researchers are studying pirfenidone, an FDA-approved drug for Idiopathic Pulmonary Fibrosis, to assess its safety, tolerability, and potential benefits in RAP patients based on promising preclinical findings. This clinical trial is a randomized, double-blind, placebo-controlled pilot study comparing pirfenidone to placebo treatments over six months in patients aged 18 to 85 with RAP. Participants assigned to the pirfenidone group will receive escalating doses starting from 267 mg three times daily in the first week to 801 mg three times daily from day 15 onward, not exceeding 2403 mg daily. The study will measure safety, tolerability, and early signs of efficacy in reducing inflammation and preventing pancreatitis attacks. Participants will undergo monitoring for adverse events during the six-month treatment period and will be followed for up to two years to assess recurrence of acute pancreatitis, severity of attacks, emergency room visits, quality of life, and patient-reported outcomes. Laboratory markers of inflammation and development of chronic pancreatitis or diabetes will also be evaluated. The study involves questionnaires and clinical assessments to evaluate the impact of pirfenidone on RAP outcomes and patient well-being.
CONDITIONS
Brief 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 acute pancreatitis attacks separated by at least 3 months, confirmed by elevated amylase or lipase, imaging, or typical pain
- Discharged from hospital 30 days after mild AP or improving and asymptomatic after moderate/severe AP
- Able to understand and willing to sign informed consent
- Willing and able to follow the trial protocol and attend follow-up
- Second acute pancreatitis episode despite correction of known causes (e.g., cholecystectomy for biliary pancreatitis, controlled triglyceride levels, stopped culprit medication)
You will not qualify if you...
- Age under 18 or over 85 years
- Body weight over 200 kg
- Ongoing acute pancreatitis or diagnosis within last 30 days
- Diagnosis of chronic pancreatitis by imaging or criteria
- Known allergy to pirfenidone
- Elevated liver enzymes (AST/ALT >3x normal) or alkaline phosphatase >2.5x normal
- Bilirubin above 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 (Child-Pugh B or C)
- Paralytic ileus or severe nausea/vomiting preventing light diet
- Chronic diarrhea for over 6 months without steatorrhea
- Active cancer treatment or cancer-free less than 3 years (except non-melanoma skin cancer)
- End-stage cancer receiving palliative care
- Infective hepatitis unless treated and cured
- Ongoing photosensitivity or rash
- Live vaccines or infectious agents within 1 month
- Pregnancy or lactation
- Women of childbearing potential not using effective contraception
- Participation in other investigational drug trials within 3 months
- Problematic alcohol or substance use disorders
- Family or personal history of long QT syndrome
- Use of strong or moderate CYP1A2 inhibitors
- Renal disease with GFR less than 30
- Any condition likely to lead to death within 2 years or worsened by pirfenidone side effects
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 6 months
Participants receive either pirfenidone or placebo to evaluate safety, tolerability, and efficacy in reducing inflammation and recurrent acute pancreatitis attacks.
Regular visits for medication monitoring and assessments throughout treatment
Duration - Up to 2 years after treatment
Participants are monitored for long-term outcomes including recurrence of pancreatitis, severity, emergency visits, quality of life, and patient-reported outcomes.
Periodic visits for ongoing evaluations
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.
S
Santhi Swaroop Vege, M.D.
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
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