Status:
COMPLETED
A Study of Auxora in Patients With Acute Pancreatitis and Accompanying SIRS
Lead Sponsor:
CalciMedica, Inc.
Conditions:
Acute Pancreatitis
Systemic Inflammatory Response Syndrome
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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 o...
Detailed Description
This double blind, randomized, placebo-controlled study will evaluate the efficacy, safety, and tolerability of three different dose levels of Auxora in patients with acute pancreatitis and accompanyi...
Eligibility Criteria
Inclusion
- All of the following must be met for a patient to be randomized into the study:
- 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:
- Serum lipase \> 3 times the upper limit of normal (ULN);
- Characteristic findings of acute pancreatitis on abdominal imaging;
- The diagnosis of SIRS has been established by the presence of at least two of the following four criteria:
- Temperature \< 36°C or \> 38°C;
- Heart rate \> 90 beats/minute;
- Respiratory rate \>20 breaths/minute or arterial carbon dioxide tension (PaCO2) \<32 mmHg;
- White blood cell count (WBC) \>12,000 mm3, or \<4,000 mm3, or \> 10% immature (band) forms;
- At least one of the following criteria is also present:
- 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;
- Abdominal examination documenting either abdominal guarding or rebound tenderness;
- Hematocrit ≥44% for men or ≥40% for women;
- The patient is ≥ 18 years of age;
- 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;
- 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;
- 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;
- 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
- Patients with any of the following conditions or characteristics must be excluded from randomizing:
- Expected survival \<6 months;
- Suspected presence of cholangitis in the judgment of the treating physician;
- The patient has a known history of:
- Organ or hematologic transplant;
- HIV, hepatitis B, or hepatitis C infection;
- Chronic pancreatitis;
- Current treatment with:
- Chemotherapy;
- Immunosuppressive medications or immunotherapy
- Pancreatic enzyme replacement therapy;
- Hemodialysis or Peritoneal Dialysis;
- The patient is known to be pregnant or is nursing;
- The patient has participated in another study of an investigational drug or therapeutic medical device in the 30 days before randomization;
- Allergy to eggs or known hypersensitivity to any components of study drug.
Key Trial Info
Start Date :
March 24 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 15 2024
Estimated Enrollment :
216 Patients enrolled
Trial Details
Trial ID
NCT04681066
Start Date
March 24 2021
End Date
May 15 2024
Last Update
October 16 2025
Active Locations (37)
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1
Long Beach Medical Center
Long Beach, California, United States, 90806
2
LA County Hospital - USC
Los Angeles, California, United States, 90033
3
Cedars Sinai
Los Angeles, California, United States, 90048
4
University of California at Irvine Medical Center
Orange, California, United States, 92868