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Auxora for Acute Pancreatitis (CARPO Trial)
CARPO Trial Summary
This trial will study the effects of Auxora, a new potential treatment for acute pancreatitis, in 216 patients. Patients will be randomly assigned to one of three dose levels of Auxora or one of three placebo volumes. Study drug infusions will occur every 24 hours for three consecutive days for a total of three infusions. Patients will remain hospitalized as per standard of care and once discharged will be asked to complete a daily meal diary and return for a Day 30 safety assessment.
CARPO Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowCARPO Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.CARPO Trial Design
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Who is running the clinical trial?
Media Library
- I am currently undergoing treatment.I have been diagnosed with acute pancreatitis.I or my legal representative can consent to and follow the study requirements.I have had an organ or bone marrow transplant.I do not have HIV, hepatitis B, or hepatitis C.I am not on immunosuppressive medications or immunotherapy.I am 18 years old or older.I agree to use birth control for 6 months after my last dose.My pancreas has no necrosis, calcifications, pseudocysts, or previous surgeries.I am a man who will use birth control for 6 months after the last drug dose and won't donate sperm.Your doctor thinks you might have a type of infection called cholangitis.I have chronic pancreatitis.I am on hemodialysis or peritoneal dialysis.I am currently undergoing chemotherapy.I am on pancreatic enzyme replacement therapy.I am allergic to eggs or sensitive to the study drug's components.You meet at least one of the following conditions:You have pain in your abdomen and it hurts when the doctor presses on it or releases pressure.Your doctor believes that you have less than 6 months to live.I'm sorry, but it seems like you didn't provide the complete criterion. Could you please provide the complete criterion so that I can rewrite it for you?
- Group 1: Placebo (1.25, 0.625, or 0.3125 mL/kg)
- Group 2: 0.5 mg/kg (0.3125 mL/kg)
- Group 3: 2.0 mg/kg (1.25 mL/kg)
- Group 4: 1.0 mg/kg (0.625 mL/kg)
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
Are there any vacancies for individuals who would like to participate in this research?
"Affirmative. The clinicaltrials.gov page for this trial verifies that recruitment is open, with the initial post date being March 24th 2021 and the last update taking place on November 30th 2022. 216 individuals are necessary to be recruited from a total of 30 sites."
How many volunteers have registered for this trial as of now?
"The sponsor, CalciMedica Inc., requires a sum of 216 participants that meet the trial's eligibility criteria for this study to be conducted. These patients will be recruited from Regional One Health in Memphis and UCLA Ronald Reagan Medical Centre in Los Angeles."
In how many venues is this clinical research being administered?
"Currently, there are 30 medical centres participating in this trial. Major cities such as Memphis, Los Angeles and Houston have sites available, with other locations spread accross the country. To minimize strain on patients enrolled in the study, it is recommended to choose a site near your residence."
To what degree is 1.0 mg/kg (0.625 mL/kg) hazardous to patients?
"Our team at Power rated the safety of 1.0 mg/kg (0.625 mL/kg) with a score of 2 due to the preliminary evidence backing its security, as it is currently being tested in Phase 2 trials without any efficacy data yet collected."
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