A Study of Auxora in Patients With Acute Pancreatitis and Accompanying SIRS

ID#: NCT04681066

Age: 18 years - 66+

Gender: All

Healthy Subjects: No

Study Phase: Phase 2

Recruitment Status: Recruiting

Start Date: March 24, 2021

End Date: October 01, 2022

Contact Information:
Liisa Tingue
9725231073
Summary: Approximately 216 patients with acute pancreatitis and accompanying SIRS will be randomized at approximately 30 sites. Patients will be randomly assigned to either Auxora at one of three dose levels or one of three placebo volumes to maintain the double-blind. 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. It is recommended that patients randomized in the study should not be discharged from the hospital until solid food is tolerated, abdominal pain has resolved or been adequately controlled, and there is no clinical evidence of infection.
Eligibility:

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 12 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 12 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.