Safety and Tolerability of Pirfenidone in Acute Pancreatitis
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 demons
| Condition(s) | Pancreatitis, Acute |
|---|---|
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Study type | Interventional |
| 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 o |
| Who can participate | Inclusion Criteria: 1. Patients 18 - 85 years of age 2. Admitted to hospital for AP, 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- acute onset of a persistent, severe, epigastric pain often radiating to the back 3. Patients identified, approached, and consented to administer study medication or placebo within 48 hours of diagnosis of AP. 4. Predicted to have MSAP or SAP by presence of one or more of the following criteria 1. APACHE II ≥ 8 2. Modified Glasgow or Imrie score ≥ 3 3. CRP \> 150 mg/dL 4. PASS score \> 140 at or within 48 hrs. of admission 5. CT or MRI imaging suggesting pancreatic and/or peri-pancreatic necro |
| Ages | 18 Years to 85 Years |
| Sex | All |
| Lead sponsor | University of Alabama at Birmingham |
| Locations | Birmingham, Alabama, United States; Rochester, Minnesota, United States |
| Start date | 2023-08-01 |
| NCT ID | NCT05350371 |
| Official listing | https://clinicaltrials.gov/study/NCT05350371 |