Evaluation of Pirfenidone as a Novel Therapeutic Strategy Against Recurrent Acute Pancreatitis.
University of Alabama at Birmingham
Summary
This clinical will evaluate the safety, tolerability and early efficacy of pirenidone in patients with recurrent acute pancreatitis.
Description
Background: Recurrent Acute Pancreatitis (RAP) is occurrence of 2 or more distinct episodes of Acute Pancreatitis (AP) (separated by at least 3 months). RAP not only leads to significant morbidity and reduced quality of life; patients with RAP have a substantial (up to 40%) risk of progressing to chronic pancreatitis (CP). Unfortunately, there is no therapy, which can help prevent future attacks of pancreatitis in RAP patients. In this regard, our published work suggest that pirfenidone, a therapy approved by FDA for the treatment of Idiopathic Pulmonary Fibrosis (IPF), has the potential to em…
Eligibility
- Age range
- 18–85 years
- Sex
- All
- Healthy volunteers
- No
A- Inclusion Criteria: 1. Patients 18 - 85 years of age 2. Two or more documented attacks of acute pancreatitis, separated by 3 months from one another, defined by at least 2 of the following 3: 1. amylase or lipase values, or both, that are greater than 3 times the upper limit of normal values 2. characteristic cross-sectional imaging 3. typical upper abdominal pain according to the revised Atlanta classification28 3. Drug/placebo treatment to start 1. Mild AP Patient is discharged out of the hospital 30 days after diagnosis of mild AP 2. Moderate Severe or Severe AP Patient…
Interventions
- DrugPirfenidone
Pirfenidone Days 1-7: 267 mg PO TID (801 mg/day) Days 8-14: 534 mg PO TID (1602 mg/day) Day 15 and thereafter: 801 mg PO TID; not to exceed 2403 mg/day Duration of treatment- total 6 months
- DrugPlacebo
Placebo
Locations (2)
- UABBirmingham, Alabama
- Mayo ClinicRochester, Minnesota