Safety and Tolerability of Pirfenidone in Acute Pancreatitis
Status:
Not yet recruiting
Trial end date:
2025-01-01
Target enrollment:
Participant gender:
Summary
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. Following are the objectives of the proposed
clinical trial:
Primary Objective:
- To evaluate the safety and tolerability of pirfenidone, compared to placebo, in patients
predicted to have moderately severe or severe AP.
- To evaluate the efficacy of pirfenidone in reducing the laboratory markers of
inflammation and improving patient reported outcome measures.
Secondary Objective:
- To evaluate the efficacy of pirfenidone in reducing the severity of acute pancreatitis, as
measured by well-defined endpoints.