Safety and Tolerability of Pirfenidone in Acute Pancreatitis (NCT05350371) | Clinical Trial Compass
RecruitingPhase 1/2
Safety and Tolerability of Pirfenidone in Acute Pancreatitis
United States60 participantsStarted 2023-08-01
Plain-language 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.
Who can participate
Age range18 Years – 85 Years
SexALL
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Inclusion criteria
✓. 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
Exclusion criteria
✕. Age \< 18 or \> 85 years
✕. Body weight \> 200 kg
What they're measuring
1
Development of anticipated or un-anticipated serious adverse events (class 3 or 4)
Timeframe: 6 months
2
percentage of patients starting and completion of the planned drug treatment
Timeframe: 7 days
3
Changes in C-reactive protein (CRP), TNF-α, interleukin (IL)-6, IL-8 and IL-10 levels
Timeframe: 7 days
4
percentage of patients having decrease in PAN-PROMISE score by at least 10 points at 72h after initiation of the drug