Auxora in Acute Pancreatitis and Accompanying Systemic Inflammatory Response Syndrome

What is the Purpose of this Study?

The purpose of this study is to determine whether an experimental drug called Auxora is safe to use in people who have acute pancreatitis with accompanying systemic inflammatory response syndrome (SIRS). Acute pancreatitis with SIRS is a condition in which the pancreas has suddenly become swollen and is causing serious complications in other parts of the body. Researchers aim to identify the best dose of the drug to give to patients and will test 3 doses of Auxora against placebo (inactive substance). Participants will be randomly assigned to receive Auxora plus standard care or standard care and placebo; their chance of receiving a dose is 75% (for every 1 who receives placebo, 3 receive a dose of Auxora).

Eligibility

All of the following must be met for a patient to be randomized into the study:
1. The diagnosis of acute pancreatitis has been established by the presence of abdominal pain consistent with acute pancreatitis together with at least 1 of the following 2 criteria:

Inclusion Criteria:

All of the following must be met for a patient to be randomized into the study:
1. The diagnosis of acute pancreatitis has been established by the presence of abdominal pain consistent with acute pancreatitis together with at least 1 of the following 2 criteria:
1. Serum lipase \> 3 times the upper limit of normal (ULN);
2. Characteristic findings of acute pancreatitis on abdominal imaging;
2. The diagnosis of SIRS has been established by the presence of at least two of the following four criteria:
1. Temperature \< 36°C or \> 38°C;
2. Heart rate \> 90 beats/minute;
3. Respiratory rate \>20 breaths/minute or arterial carbon dioxide tension (PaCO2) \<32 mmHg;
4. White blood cell count (WBC) \>12,000 mm3, or \<4,000 mm3, or \> 10% immature (band) forms;
3. At least one of the following criteria is also present:
1. A peripancreatic fluid collection or a pleural effusion on a contrast-enhanced computed tomography (CECT) performed in the 24 hours before Consent or after Consent and before Randomization;
2. Abdominal examination documenting either abdominal guarding or rebound tenderness;
3. Hematocrit ≥44% for men or ≥40% for women;
4. The patient is ≥ 18 years of age;
5. Lack of pancreatic necrosis, pancreatic calcifications, pancreatic pseudocysts and no evidence for previous necrosectomy or pancreatic surgery identified by CECT performed in the 24 hours before Consent or after Consent and before Randomization;
6. A female patient of childbearing potential who is sexually active with a male partner is willing to practice acceptable methods of birth control for 180 days after the last dose of study drug. A female patient must not attempt to become pregnant for 180 days;
7. A male patient who is sexually active with a female partner of childbearing potential is willing to practice acceptable methods of birth control for 180 days after the last dose of study drug. A male patient must not donate sperm for 180 days;
8. The patient is willing and able to, or has a legal authorized representative (LAR) who is willing and able to, provide informed consent to participate, and to cooperate with all aspects of the protocol.

Exclusion Criteria:

Patients with any of the following conditions or characteristics must be excluded from randomizing:
1. Expected survival \<6 months;
2. Suspected presence of cholangitis in the judgment of the treating physician;
3. The patient has a known history of:
1. Organ or hematologic transplant;
2. HIV, hepatitis B, or hepatitis C infection;
3. Chronic pancreatitis;
4. Current treatment with:
1. Chemotherapy;
2. Immunosuppressive medications or immunotherapy
3. Pancreatic enzyme replacement therapy;
4. Hemodialysis or Peritoneal Dialysis;
5. The patient is known to be pregnant or is nursing;
6. The patient has participated in another study of an investigational drug or therapeutic medical device in the 30 days before randomization;
7. Allergy to eggs or known hypersensitivity to any components of study drug.

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Where can I participate?

Beverly

More about this Clinical Trial

What is the full name of this clinical trial?

A Randomized, Double-Blind, Placebo Controlled Dose-Ranging Study of Auxora in Patients with Acute Pancreatitis and Accompanying Systemic Inflammatory Response Syndrome

Study Details

Disease Type/Condition

Other

Principal Investigator

Pandol, Stephen

Age Group

Adult

Phase

IRB Number

STUDY00002230

ClinicalTrials.gov ID

NCT04681066

Key Eligibility

ClinicalTrials.gov

How do I learn more about this study?

clinicaltrials@cshs.org