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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04681066
Recruitment Status : Recruiting
First Posted : December 23, 2020
Last Update Posted : August 17, 2022
Sponsor:
Information provided by (Responsible Party):
CalciMedica, Inc.

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 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 necessitating continued hospitalization.

Condition or disease Intervention/treatment Phase
Acute Pancreatitis Systemic Inflammatory Response Syndrome Drug: CM-4620 Injectable Emulsion or CM-4620-IE Other: Placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 216 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: Matching placebo
Primary Purpose: Treatment
Official Title: A Randomized, Double-Blind, Placebo Controlled Dose-Ranging Study of Auxora in Patients With Acute Pancreatitis and Accompanying Systemic Inflammatory Response Syndrome
Actual Study Start Date : March 24, 2021
Estimated Primary Completion Date : September 2023
Estimated Study Completion Date : September 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Pancreatitis

Arm Intervention/treatment
Active Comparator: 2.0 mg/kg (1.25 mL/kg)
administered intravenously over 4 hours at a constant rate of infusion. They will be administered every 24 hours (±1 hours) for three consecutive days for a total of 3 doses.
Drug: CM-4620 Injectable Emulsion or CM-4620-IE
Auxora is to be administered as an IV infusion and is supplied as a translucent, white to yellowish colored, sterile, non-pyrogenic emulsion containing 1.6 mg/mL of the active pharmaceutical ingredient CM4620. CM4620-IE is supplied as an 80 mL fill in a 100 mL, single-use glass vial. The drug product is formulated as an emulsion due to the low solubility of CM4620 in aqueous solution. CM4620-IE contains egg phospholipids, medium chain triglycerides, glycerin, edetate disodium salt dehydrate (EDTA), sodium hydroxide (as needed to adjust pH), and sterile water for injection.
Other Name: Auxora

Active Comparator: 1.0 mg/kg (0.625 mL/kg)
administered intravenously over 4 hours at a constant rate of infusion. They will be administered every 24 hours (±1 hours) for three consecutive days for a total of 3 doses.
Drug: CM-4620 Injectable Emulsion or CM-4620-IE
Auxora is to be administered as an IV infusion and is supplied as a translucent, white to yellowish colored, sterile, non-pyrogenic emulsion containing 1.6 mg/mL of the active pharmaceutical ingredient CM4620. CM4620-IE is supplied as an 80 mL fill in a 100 mL, single-use glass vial. The drug product is formulated as an emulsion due to the low solubility of CM4620 in aqueous solution. CM4620-IE contains egg phospholipids, medium chain triglycerides, glycerin, edetate disodium salt dehydrate (EDTA), sodium hydroxide (as needed to adjust pH), and sterile water for injection.
Other Name: Auxora

Active Comparator: 0.5 mg/kg (0.3125 mL/kg)
administered intravenously over 4 hours at a constant rate of infusion. They will be administered every 24 hours (±1 hours) for three consecutive days for a total of 3 doses.
Drug: CM-4620 Injectable Emulsion or CM-4620-IE
Auxora is to be administered as an IV infusion and is supplied as a translucent, white to yellowish colored, sterile, non-pyrogenic emulsion containing 1.6 mg/mL of the active pharmaceutical ingredient CM4620. CM4620-IE is supplied as an 80 mL fill in a 100 mL, single-use glass vial. The drug product is formulated as an emulsion due to the low solubility of CM4620 in aqueous solution. CM4620-IE contains egg phospholipids, medium chain triglycerides, glycerin, edetate disodium salt dehydrate (EDTA), sodium hydroxide (as needed to adjust pH), and sterile water for injection.
Other Name: Auxora

Placebo Comparator: Placebo (1.25, 0.625, or 0.3125 mL/kg)
patients randomized to placebo will receive one of three following volumes (1.25 mL/kg, 0.625 mL/kg, and 0.3125 mL/kg. although three volumes - all patients randomized to placebo will be analyzed together as one arm. administered intravenously over 4 hours at a constant rate of infusion. They will be administered every 24 hours (±1 hours) for three consecutive days for a total of 3 doses.
Other: Placebo
Matching Placebo is to be administered as an IV infusion and is supplied as a translucent, white to yellowish, sterile, non-pyrogenic emulsion carrier containing no active pharmaceutical ingredient. Placebo is supplied as an 80 mL fill in a 100 mL single-use vial. Placebo contains the same ingredients as Auxora except that it does not contain CM4620.




Primary Outcome Measures :
  1. Time to solid food tolerance [ Time Frame: from start of first infusion of study drug (SFISD) to day 30 ]
    Defined as the number of hours from the date and time of the start of the first infusion of study (SFISD) for the patient to the date and time the patient receives a solid meal that is tolerated


Secondary Outcome Measures :
  1. Solid food tolerance [ Time Frame: from SFISD to 48 hours, 72 hours and 96 hours and at time of hospital discharge ]
  2. Time to medically indicated discharge [ Time Frame: from start of first infusion of study drug and through time of hospital discharge or through Day 30, whichever occurs first ]
  3. Length of stay in the hospital [ Time Frame: from admission date into the hospital until discharge date from the hospital ]
  4. Length of stay in the ICU for patients admitted to the ICU [ Time Frame: from admission into ICU until discharge from ICU ]
  5. Re-hospitalization for acute pancreatitis by Day 30 [ Time Frame: time from initial date of hospital discharge through date of re-hospitalization through day 30 ]
  6. Change in severity of acute pancreatitis by CTSI score from screening to Day 30 [ Time Frame: from informed consent through day 30 ]
  7. Development of pancreatic necrosis ≥30% and >50% [ Time Frame: from enrollment CECT through Day 30 CECT ]
  8. The persistence of SIRS ≥48 hours after the SFISD [ Time Frame: from SFISD through day 30 ]
  9. Incidence, severity, and duration of organ failure [ Time Frame: from enrollment and through day 30 ]
  10. Mortality by Day 30 [ Time Frame: from randomization and through day 30 ]
  11. Change in pain score [ Time Frame: from enrollment through day 30 ]
  12. Change in opioid use [ Time Frame: from enrollment through day 30 ]

Other Outcome Measures:
  1. Development of infected pancreatic necrosis [ Time Frame: from enrollment CECT through Day 30 CECT ]
    Exploratory

  2. Development of sepsis [ Time Frame: from randomization through day 30 ]
    Exploratory

  3. Hospital procedures for the management of pancreatic necrosis [ Time Frame: from randomization through day 30 ]
    Exploratory

  4. Change in GCSI-DD score [ Time Frame: from randomization through day 30 ]
    Exploratory

  5. Change in albumin [ Time Frame: from randomization through day 30 ]
    Exploratory

  6. Change in ANC/ALC ratio and IL-6 levels [ Time Frame: from randomization through day 30 ]
    Exploratory

  7. Change in urine NGAL [ Time Frame: from randomization through day 30 ]
    Exploratory



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Gender Based Eligibility:   Yes
Gender Eligibility Description:   self-reported gender
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04681066


Contacts
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Contact: Liisa Tingue 9725231073 liisa@calcimedica.com

Locations
Show Show 26 study locations
Sponsors and Collaborators
CalciMedica, Inc.
Investigators
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Study Director: Sudarshan Hebbar, MD CalciMedica, Inc.
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Responsible Party: CalciMedica, Inc.
ClinicalTrials.gov Identifier: NCT04681066    
Other Study ID Numbers: CM4620-203
First Posted: December 23, 2020    Key Record Dates
Last Update Posted: August 17, 2022
Last Verified: August 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Pancreatitis
Syndrome
Systemic Inflammatory Response Syndrome
Disease
Pathologic Processes
Pancreatic Diseases
Digestive System Diseases
Inflammation
Shock