Evaluation of Pirfenidone as a Therapy in Patients With Predicted Moderate to Severe Acute Pancreatitis
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.
• Patients 18 - 85 years of age
• Admitted to hospital for AP, defined by at least 2 of the following 3:
‣ amylase or lipase values, or both, that are greater than 3 times the upper limit of normal values
⁃ characteristic cross-sectional imaging
⁃ typical upper abdominal pain- acute onset of a persistent, severe, epigastric pain often radiating to the back
• Patients identified, approached, and consented to administer study medication or placebo within 48 hours of diagnosis of AP.
• Predicted to have MSAP or SAP by presence of one or more of the following criteria
‣ APACHE II ≥ 8
⁃ Modified Glasgow or Imrie score ≥ 3
⁃ CRP \> 150 mg/dL
⁃ PASS score \> 140 at or within 48 hrs. of admission
⁃ CT or MRI imaging suggesting pancreatic and/or peri-pancreatic necrosis