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 had two or more episodes of acute pancreatitis, each at least 3 months apart, confirmed by blood tests showing high enzyme levels, imaging scans, and/or typical upper belly pain.
• If your pancreatitis was caused by gallstones, you have already had your gallbladder removed (with or without an additional procedure called ERCP if needed).
• If your pancreatitis was caused by very high fat levels in the blood (triglycerides), your levels are now below 400 while taking medication.
• If your pancreatitis was caused by a medication, you have stopped taking that medication but still had another episode.
• You have recovered enough from your most recent episode to be discharged from hospital, are not in significant pain, are able to eat a light diet, and have no fever or chills.
• You are willing and able to sign a consent form and follow the trial schedule.

Who may not be able to join:

• You are under 18 or over 85 years old.
• You weigh more than 200 kg (about 440 lbs).
• You are currently having an active episode of pancreatitis, or were diagnosed with pancreatitis in the last 30 days.
• You have been diagnosed with chronic (long-term) pancreatitis, based on specific findings on scans or ultrasound.
• You have a known allergy or sensitivity to the study drug, Pirfenidone.
• Your liver function blood tests are significantly abnormal (confirm with trial site for specific values).
• You have moderate to severe heart failure or serious coronary heart disease.
• You require oxygen or a breathing machine at home.
• You have advanced liver disease (cirrhosis classified as Child-Pugh B or C).
• You have a condition that prevents you from eating a light diet, such as a blocked bowel or severe nausea and vomiting.
• You have chronic diarrhea lasting more than 6 months with 3 or more loose stools per day.
• You are currently being treated for cancer, or have had cancer in the last 3 years (common non-dangerous skin cancers are generally not excluded — confirm with trial site).
• You have end-stage cancer receiving palliative (comfort-focused) care.
• You have a known history of hepatitis B or C, unless you have documented proof of successful treatment and cure.
• You currently have an ongoing skin rash or sensitivity to light (photosensitivity).
• You have received a live vaccine in the past month.
• You are currently pregnant or breastfeeding.
• You are a woman who could become pregnant and are not using oral contraceptives, injectable contraceptives, or an IUD, or are unwilling to use reliable contraception during and for 90 days after taking the study drug.
• You are currently taking part in another clinical trial involving a medicine, or have done so in the last 3 months.
• You have a problematic pattern of alcohol use or moderate to severe alcohol use disorder.
• You have a substance use disorder (except marijuana use), unless you completed a rehabilitation program, have been substance-free for at least one year, and have a good support system.
• You or a family member has a known history of a heart rhythm condition called long QT syndrome.
• You are currently taking certain medications that affect how the body processes drugs (specifically strong or moderate CYP1A2 inhibitors, such as fluvoxamine, enoxacin, or ciprofloxacin — confirm with trial site).
• You have significant kidney disease (GFR below 30 — confirm with trial site).
• You have any other serious condition that the trial doctor believes could put you at serious risk or be made worse by the study drug.

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