Phase 2 Pancreatitis Trial, Recruiting

Written by an AI model from ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

• You are between 18 and 85 years old
• You have been admitted to hospital with acute pancreatitis, confirmed by at least 2 of the following: blood tests showing high enzyme levels (amylase or lipase), a scan showing typical signs of pancreatitis, or sudden severe upper abdominal pain that may spread to your back
• You are able to start the study medication or placebo within 48 hours of being diagnosed with acute pancreatitis
• Your pancreatitis is predicted to be moderate or severe, based on certain medical scoring systems, blood test results, or scan findings showing damage to the pancreas or surrounding tissue (confirm with trial site)

Who may not be able to join:

• You are under 18 or over 85 years old
• You weigh more than 200 kg
• More than 48 hours have passed since your pancreatitis was diagnosed before you could be enrolled
• You have had acute pancreatitis in the last 30 days, or currently have an ongoing episode
• You have chronic (long-term) pancreatitis
• You have a known allergy or sensitivity to the study drug, pirfenidone
• Your liver blood tests (AST, ALT, alkaline phosphatase, or bilirubin) are above certain levels, suggesting liver stress or damage
• You have moderate to severe heart failure or significant coronary heart disease
• You currently use oxygen or a breathing machine at home
• You have advanced liver disease
• You have a blockage in your bowel, or severe nausea, vomiting, or chronic diarrhoea
• You have a condition that weakens your immune system, or you take medications that suppress your immune system
• You have an active or advanced cancer, or a cancer being managed with palliative (end-of-life) care
• You had a known infection before your pancreatitis started
• You have a history of hepatitis (a liver infection)
• You have received a live vaccine or a treatment using infectious agents within the past month
• You are pregnant or breastfeeding
• You currently have a skin rash or sensitivity to light (photosensitivity)
• You are a woman who could become pregnant and are not using oral or injectable contraceptives, an IUD, or willing to abstain from sex for 4 weeks during the study
• You are currently in another clinical trial testing a medication, or have been in one in the last 3 months
• You have had problems with alcohol or substance misuse in the past 2 years
• You or a family member has a history of a heart rhythm condition called long QT syndrome, or your QT interval on a heart tracing is greater than 500 msec (confirm with trial site)
• You currently take certain medications, including fluvoxamine (an antidepressant) or sildenafil (used for erectile dysfunction or pulmonary hypertension)
• You have significant kidney disease with poor kidney function (GFR below 30)
• You have another serious condition that the trial doctor believes may cause your death within the next 2 years
• You have any condition that, in the trial doctor's opinion, could be made significantly worse by the known side effects of pirfenidone

Important: Always verify eligibility with the trial site directly before applying.