Study of Pirfenidone to Treat Recurrent Acute Pancreatitis in Adults Aged 18 to 85

What this Trial Is About

Researchers are evaluating the safety, tolerability, and early effectiveness of pirfenidone in adults with recurrent acute pancreatitis RAP. RAP is characterized by two or more distinct episodes of acute pancreatitis separated by at least three months, leading to significant health problems and a risk of progressing to chronic pancreatitis. Currently, no treatments exist to prevent future attacks. This study aims to test pirfenidone, a drug already used for lung fibrosis, as a possible new therapy for RAP based on promising animal and laboratory studies. Participants will be randomly assigned to receive either pirfenidone or a placebo for six months in a double-blind setup. The pirfenidone dosing starts at 801 mg per day for the first week, increasing to 1602 mg per day in the second week, and then to 2403 mg per day from day 15 onward. The study will monitor the safety and tolerability of the drug as well as its effects on inflammation markers, acute pancreatitis recurrence, severity, emergency visits, quality of life, and patient-reported outcomes. This is a controlled clinical trial conducted at multiple sites. Throughout the six-month treatment, participants will be closely monitored with laboratory tests and questionnaires assessing inflammation, pancreatitis episodes, hospital visits, and quality of life. The study also plans to develop a biomarker to predict who might benefit most from pirfenidone. Safety will be tracked by recording any adverse events. Follow-up assessments will continue to two years to evaluate long-term effects such as chronic pancreatitis and diabetes development. The total participation time may last up to two years.

Evaluation of Pirfenidone as a Novel Therapeutic Strategy Against Recurrent Acute Pancreatitis.