Phase 1 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 have been diagnosed with high triglycerides (a type of fat in the blood) that has not been well controlled by standard treatments and diet, and you have had at least two episodes of pancreatitis (painful inflammation of the pancreas) or one severe episode within the last 5 years.
• Your fasting blood triglyceride levels are above 5.65 mmol/L, measured after eating less than 30g of dietary fat in the 24 hours before the blood test.
• Genetic testing has shown you carry a change (mutation) in either the GPIHBP1 or LPL gene.
• If you are of childbearing age, you are willing to use effective contraception from the time of screening until 6 months after the trial ends.
• You fully understand what the trial involves, are willing to follow a low-fat diet, provide biological samples, and complete the trial as planned.
• You (or your legal guardian) are able to understand the trial procedures and are willing to sign a consent form to participate voluntarily.

Who may not be able to join:

• You have a known allergy to any ingredient in the trial drug (including immunosuppressants), or have a condition that prevents you from receiving this treatment.
• You currently have an active infection caused by bacteria, fungi, viruses, or any other source.
• You cannot tolerate immunosuppressive drugs or steroid medications.
• You have any of the following serious medical conditions, either now or in your past:
  • Ongoing unrelieved abdominal pain from a current episode of pancreatitis or any other cause.
  • A history of cancer, or currently have any form of cancer.
  • An autoimmune disease (where the body's immune system attacks itself).
  • A history of epilepsy or a mental health condition such as schizophrenia, depression, mania, or anxiety.
  • Certain heart conditions, including heart muscle disease, heart inflammation, structural heart problems, coronary heart disease, heart attack, severe irregular heartbeat, or significantly reduced heart function (confirm with trial site).
  • Poorly controlled diabetes, with fasting blood sugar at or above 11.1 mmol/L.
  • High blood pressure that remains above 150/100 mmHg even after at least 4 weeks on a stable dose of blood pressure medication.
• Your blood test results at screening show any of the following:
  • Liver enzyme levels (AST or ALT) more than twice the normal upper limit.
  • Bilirubin (a liver-related substance) above the normal upper limit.
  • Creatinine (a kidney-related substance) above the normal upper limit.
  • A muscle enzyme (phosphate kinase) more than twice the normal upper limit.
  • Reduced kidney filtering ability (below 50 mL/min, confirm with trial site).
  • A positive test for Hepatitis B, Hepatitis C, HIV, or syphilis.
  • A positive pregnancy test.
• You have high levels of antibodies against AAV5 (a component related to the trial drug) above a specific threshold (confirm with trial site).
• You have taken part in another clinical trial within the past 30 days, or plan to join another trial during this one.
• You have lost or donated more than 400 mL of blood (not including normal menstrual blood loss), or received a blood transfusion or blood products, within the past 90 days.
• You have had major surgery within the past 90 days, or surgery that could affect how the trial drug works or how your safety is monitored.
• You have been drinking heavily in the past 90 days (more than 3 units of alcohol per day for men, or 2 units per day for women), or you are unable to stop drinking alcohol during the trial.
• You are currently pregnant, trying to become pregnant, or breastfeeding; or you are of childbearing age and unable to use effective contraception until at least 3 months after the trial ends.
• You are unlikely to be able to follow the trial requirements for any reason, or the trial doctor considers it unsuitable for you to participate.

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