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CTRI Number  CTRI/2023/05/053175 [Registered on: 29/05/2023] Trial Registered Prospectively
Last Modified On: 16/09/2024
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   A Study of Auxora in Patients With Acute Pancreatitis and Accompanying SIRS 
Scientific Title of Study   A Randomized, Double-Blind, Placebo Controlled Dose-Ranging Study of Auxora in Patients with Acute Pancreatitis and Accompanying Systemic Inflammatory Response Syndrome (CARPO) 
Trial Acronym   
Secondary IDs if Any
Modification(s)  
Secondary ID  Identifier 
CM4620-203 Version 4.0 Dated 05 Oct 2023  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Jayashri Krishnan 
Designation  Vice President Operations 
Affiliation  JSS Medical Research Asia pacific Private Limited 
Address  Tower 2, 1st Floor, South Wing, L&T Business Park, Plot no. 12/4, Sector 27D, Delhi Mathura Road, Near Sarai Khwaja Metro Station, Faridabad-121003, Haryana, India
Tower 2, 1st Floor, South Wing, L&T Business Park, Plot no. 12/4, Sector 27D, Delhi Mathura Road, Near Sarai Khwaja Metro Station, Faridabad-121003, Haryana, India
Faridabad
HARYANA
121003
India 
Phone  09771407484  
Fax  11296613520  
Email  Jayashri.krishnan@jssresearch.com  
 
Details of Contact Person
Scientific Query

Modification(s)  
Name  Dr. Sathish Kumar P 
Designation  Medical Monitor 
Affiliation  JSS Medical Research Asia pacific Private Limited 
Address  Tower 2, 1st Floor, South Wing, L&T Business Park, Plot no. 12/4, Sector 27D, Delhi Mathura Road, Near Sarai Khwaja Metro Station, Faridabad-121003, Haryana, India
Tower 2, 1st Floor, South Wing, L&T Business Park, Plot no. 12/4, Sector 27D, Delhi Mathura Road, Near Sarai Khwaja Metro Station, Faridabad-121003, Haryana, India
Faridabad
HARYANA
121003
India 
Phone  7358005866  
Fax  11296613520  
Email  sathish.p@jssresearch.com  
 
Details of Contact Person
Public Query
 
Name  Dr Jayashri Krishnan 
Designation  Vice President Operations 
Affiliation  JSS Medical Research Asia pacific Private Limited 
Address  Tower 2, 1st Floor, South Wing, L&T Business Park, Plot no. 12/4, Sector 27D, Delhi Mathura Road, Near Sarai Khwaja Metro Station, Faridabad-121003, Haryana, India
Tower 2, 1st Floor, South Wing, L&T Business Park, Plot no. 12/4, Sector 27D, Delhi Mathura Road, Near Sarai Khwaja Metro Station, Faridabad-121003, Haryana, India
Faridabad
HARYANA
121003
India 
Phone  09771407484  
Fax  11296613520  
Email  Jayashri.krishnan@jssresearch.com  
 
Source of Monetary or Material Support  
CalciMedica, Inc. 
 
Primary Sponsor  
Name  CalciMedica, Inc. 
Address  505 Coast Boulevard South, Suite 307 La Jolla, CA 92037, United States of America (USA)  
Type of Sponsor  Pharmaceutical industry-Global 
 
Details of Secondary Sponsor  
Name  Address 
JSS Medical Research Asia Pacific Private Limited  Tower 2, 1st Floor, South Wing, L&T Business Park, Plot no. 12/4, Sector 27D, Delhi Mathura Road, Near Sarai KhwajaMetro Station, Faridabad-121003, Haryana, India 
 
Countries of Recruitment     United States of America
India  
Sites of Study
Modification(s)  
No of Sites = 17  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Vikas Singla  Max Super-Speciality Hospital, Saket, New Delhi  Room No- 1A Floor No- Basement Floor Department – Department of Gastroenterology Max Super Speciality Hospital, East Block,2, Press Enclave Road, Saket, New Delhi-110017
New Delhi
DELHI 
9968407407

vikas.singla@maxhealthcare.com 
Dr G Loganathan   Apollo Speciality Hospitals, Ayanambakkam, Chennai  Room No. – 7626 Floor No. – 6th Floor Department – Medical Gastroenterology and Hepatology Address - Apollo Speciality Hospitals, No: 64, Vanagaram to Ambattur Main Road, Ayanambakkam, Chennai-600095, Tamil Nadu India.
Chennai
TAMIL NADU 
9443233033

drloganathan_g@apollohospitals.com 
Dr Ashish Joshi  Department of Gastroenterology, S P Medical College and A G Hospitals, Bikaner  Floor No. – 1ST Floor Department – Dept. of Gastroenterology Address – Department of Gastroenterology, SSB, S P Medical College and A G Hospitals, Bikaner, Rajasthan 334001, India
Bikaner
RAJASTHAN 
9414248526

Joshidrashish@gmail.com 
Dr Neelima Deodatta Chafekar  Dr. Vasantrao Pawar Medical College Hospital & Research Centre  Room No. – 04 Floor No. – First Floor Department – Medicine Department Dr. Vasantrao Pawar Medical College Hospital and Research Centre, Nashik, Vasantdada Nagar, Adgaon, Nashik-422003, Maharashtra
Nashik
MAHARASHTRA 
9822408536

neelimachafekar@yahoo.com 
Dr Brij Sharma  Indira Gandhi Medical College and Hospitals, Shimla  Room No- 110 Floor No- 1st Floor, Block-B Department – Department of Gastroenterology Indira Gandhi Medical College and Hospitals, Ridge Sanjauli Road Lakkar Bazar, Shimla- 171001, Himachal Pradesh
Shimla
HIMACHAL PRADESH 
9418587487

drbrijsharma01@gmail.com 
Dr Suresh Kumar S  JIPMER, Puducherry  Room No- 11 Floor No- 2nd Floor, Department – Department of Surgery Institute Block,Dhanvantri Nagar,Puducherry- 605006, India
Pondicherry
PONDICHERRY 
9788637893

drsureshkumar08@gmail.com 
Dr Mathew Philip  Lisie Hospital  Room No. – 2059, Ground Floor, St. Augustin Block, Department of Gastroenterology, Lisie Hospital Road, Kathrikadavu, Kochi, Kerala 682017, India
Ernakulam
KERALA 
4842402044

drmathewphilip@gmail.com 
Dr Kranthi Kumar   Malla Reddy Narayana Multispecialty Hospital, Hyderabad  Room No. – 01 Floor No. – 01 Department - Gastroenterology Suraram X Road, Jeedimetla, Hyderabad, 500055
Hyderabad
TELANGANA 
9502150814

krantikindia@gmail.com 
Dr Sunil Kumar Dadhich  Mathura Das Mathur Hospital, Jodhpur  Room No. 103, Gastroenterology Department, First Floor. Main Road, Sector-C, Shastri Nagar, Jodhpur, Rajasthan 342003, India.
Jodhpur
RAJASTHAN 
9414136440

profsunildadhich@gmail.com 
Dr Bahar Dattatray Kulkarni  MTES’ Sanjeevan Hospital, Pune  Plot No-23, off Karve Road, Erandwane, Pune-411004, Maharashtra, India.
Pune
MAHARASHTRA 
9823436677

drbahar.kulkarni96@gmail.com 
Dr S K Sinha  PGIMER, Chandigarh  Ground Floor, Department of Gastroenterology, Nehru Hospital, F-Block, PGIMER Chandigarh, Madhya Marg, Sector 12, Chandigarh, 160012
Chandigarh
CHANDIGARH 
7087009614

sarojksinha@hotmail.com 
Dr Rahate Prashant Vithalrao  Seven Star Hospital, Nagpur  Room No. – 04 Floor No. – Ground Floor Department – Surgery Department Address - Seven Star Hospital, 324/1, Jagnade Square, Nandanvan, KDK College Road, Nagpur-440009, Maharashtra, India
Nagpur
MAHARASHTRA 
9822464068

prashantrahate84@yahoo.com 
Dr Hardik Rashmikant Parikh  Shalby Hospital, Ahmedabad  Shalby Hospital,Opp. Karnavati Club, S.G. High Way, Ahmedabad-380015, Gujarat, India.
Ahmadabad
GUJARAT 
9925027760

h.parikh81@yahoo.com 
Dr Devang Tank  Shree Giriraj Multispeciality Hospital  Room No. 101 Floor No. First Floor Department Department of Gastroenterology Shree Giriraj Multispeciality Hospital A Unit of Shree Giriraj Lifecare Pvt. Ltd. 27 Navjyot Park Corner 150 Feet Ring Road Rajkot 360005, Gujarat India.
Rajkot
GUJARAT 
9016344724

devutank@gmail.com 
Dr Rajiv Mehta  Surat Institute of Digestive Sciences (SIDS)   2nd Floor, Department of Gastroenterology, Vijay Nagar Gate 3, Ring Rd, opp. Gandhi College, Majura Gate, Surat, Gujarat-395001
Surat
GUJARAT 
9879863510

rmgastro@yahoo.com 
Dr Mamidala Venkata Rama Mohan  Vijaya Super Speciality Hospital  OPD No. -02, Ground Floor, Department of Gastroenterology Pogathota, 16 2 41A, Nellore, Andhra Pradesh 524001, India
Nellore
ANDHRA PRADESH 
9490463301

rammohanmddm@gmail.com 
Dr B Ravi Shankar  Yashoda Hospitals, Secunderabad  Room No. – 08 Floor No. – 4th Floor Department – Dept. of Medical Gastroenterology Address - Yashoda Hospitals, Behind Hari Hara Kala Bhavan, SP Road, Secunderabad - 500003, Telangana India
Hyderabad
TELANGANA 
9391075600

b_ravishankar@yahoo.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 17  
Name of Committee  Approval Status 
Clinical Studies Apollo Hospitals Enterprises Limited No-21 Greams Lane off Greams road, Chennai Tamil Nadu - 600006 India  Approved 
Dr. Vasantrao Pawar Medical College Hospital & Research Centre, Nashik  Approved 
Ethics Committee Sanjeevan Hospital, Erandwane, Pune  Approved 
ETHICS COMMITTEE, S.P. MEDICAL COLLEGE, BIKANER  Approved 
IEC Intervention Studies JIPMER JIPMER Dhanvantari Nagar Pondicherry, Puducherry - 605006 India   Approved 
IGMC Shimla INDIRA GANDHI MEDICAL COLLEGE SHIMLA Principal Office Indira Gandhi Medical College Shimla, Shimla Himachal Pradesh - 171001 India  Approved 
Institutional Ethics Committee Dr. S.N. Medical College, Jodhpur  Approved 
Institutional Ethics Committee Shalby Limited, Ahmedabad  Approved 
Institutional Ethics Committee, Devki Devi Foundation, Max Super Speciality Hospital, Saket, New Delhi, 110017   Approved 
Institutional Ethics Committee, Lisie Hospital, P.B. No. -3053, Cochin, Kerala-682018  Approved 
Institutional Ethics Committee, Post Graduate Institute of Medical Education and Research, Chandigarh, 160012  Approved 
MRMCW- Institutional Ethics Committee Malla Reddy Medical College for Women Suraram X Road Qutbullapur, Municipality, Jeedimetla Hyderabad Telangana - 500055 India   Approved 
Seven Star Hospital, Nagpur  Approved 
Shree Giriraj Multispeciality Hospital, Rajkot  Approved 
Surat Institute of Digestive Sciences EC, Surat-395002, Gujarat  Approved 
Vijaya Ethics Committee, Vijaya Super Speciality Hospital, Raghava Cini Complex Road Poghatota, Nellore, Andhra Pradesh   Approved 
Yashoda Academy of Medical Education and Research Yashoda Hospitals Behind Hari Hara kala Bhawan SP Road Secunderabad, Hyderabad Telangana - 500003 India  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Approved/Obtained 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K859||Acute pancreatitis, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  CM-4620 Injectable Emulsion (Auxora)  Patients randomized to receive Auxora will receive one of three dose levels, 2.0 mg/kg (1.25 mL/kg), 1.0 mg/kg (0.625 mL/kg), and 0.5 mg/kg (0.3125 mL/kg), every 24 hours (±1 hour) for three consecutive days for a total of three infusions. Auxora will be administered intravenously as a continuous infusion over 4 hours via a bag and tubing compatible with lipid emulsions and using a 1.2-micron filter. 
Comparator Agent  Placebo  Placebo will consist of the emulsion without any active pharmaceutical ingredient CM4620. Patients randomized to receive Placebo will receive one of three dose volumes, 1.25 mL/kg, 0.625 mL/kg, and 0.3125 mL/kg, every 24 hours (±1 hour) for three consecutive days for a total of three infusions. Placebo will be administered intravenously as a continuous infusion over 4 hours via a bag and tubing compatible with lipid emulsions and using a 1.2-micron filter.  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  75.00 Year(s)
Gender  Both 
Details  Inclusion criteria:
All of the following must be met for a patient to be randomized into the study:
1. The diagnosis of AP has been established by the presence of abdominal pain consistent with AP together with at least 1 of the following 2 criteria:
a. Serum lipase > 3 times the upper limit of normal (ULN);
b. Characteristic findings of AP on abdominal imaging;
2. The diagnosis of SIRS has been established by the presence of at least two of the following four criteria:
a. Temperature < 36°C or > 38°C;
b. Heart rate > 90 beats/minute;
c. Respiratory rate >20 breaths/minute or arterial carbon dioxide tension (PaCO2) <32 mmHg;
d. 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:
a. 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;
b. Abdominal examination documenting either abdominal guarding or rebound tenderness;
c. 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.
 
 
ExclusionCriteria 
Details  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:
a. Organ or hematologic transplant;
b. HIV, hepatitis B, or hepatitis C infection;
c. Chronic pancreatitis;
4. Current treatment with:
a. Chemotherapy;
b. Immunosuppressive medications or immunotherapy Chemotherapy -
• Cyclosporine, Tacrolimus, • Sirolimus, Everolimus, • Azathioprine, • Cyclosphosphamide, • Methotrexate,
• Mycophenolate, • Leflunomide,• Biologics/Monoclonals: abatacept, adalimumab, alemtuzumab, anakinra, basilizimab, belimumab, bevacizumab, brodalumab, canakinumab, certolizumab, cetuximab, clazakizumab, daclizumab, eculizumab, etanercept, golimumab, infliximab, interferon, ixekizumab, muromonab, natalizumab, omalizumab, rituximab, secukinumab, tocilizumab, trastuzumab, ustekinumab, vedolizumab, • Baracitinib
• Tofacitinib
c. Pancreatic enzyme replacement therapy;
d. 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.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Centralized 
Blinding/Masking   Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded 
Primary Outcome  
Outcome  TimePoints 
Time to solid food tolerance   Following the start of first Infusion (SFISD) and at each meal time  
 
Secondary Outcome  
Outcome  TimePoints 
Solid food tolerance at 48 hours, 72 hours, and
96 hours after the SFISD and at discharge
• Time to medically indicated discharge
• Length of stay in the hospital
• Length of stay in the intensive care unit (ICU)
for patients admitted to the ICU
• Re-hospitalization for AP by Day 30
• Change in severity of AP by CTSI score from
screening to Day 30
• Development of pancreatic necrosis ≥30% and
50%
• The persistence of SIRS ≥48 hours after the
SFISD
• Incidence, severity, and duration of
organ failure
• Mortality by Day 30
• Change in pain score and opioid use
 
48 hours, 72 hours and 96 hours  
 
Target Sample Size   Total Sample Size="216"
Sample Size from India="100" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   Phase 2 
Date of First Enrollment (India)   02/06/2023 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  30/03/2021 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Closed to Recruitment of Participants 
Recruitment Status of Trial (India)  Closed to Recruitment of Participants 
Publication Details    
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

Approximately 216 patients with acute pancreatitis and accompanying SIRS will be randomized at approximately 15 sites. All patients will have received a Screening CECT of the abdomen/pancreas before being randomized into the study. CECTs performed as standard of care (SOC) may be used as the Screening CECT but must have been performed in the 24 hours before Consent or after Consent and before Randomization. The Start of First Infusion of Study Drug (SFISD) should occur within 8 hours of the patient or LAR providing informed consent. Patients will be randomly assigned to either Auxora at one of three dose levels i.e, 2.0 mg/kg (1.25 mL/kg), 1.0 mg/kg (0.625 mL/kg), and 0.5 mg/kg (0.3125 mL/kg), every 24 hours (±1 hour) for three consecutive days for a total of three infusions 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 in the hospital as per the 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 also recommended that all 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 that would necessitate continued hospitalization. Tolerating solid food is defined as eating ≥50% of a low fat, ≥500-calorie solid meal without an increase in abdominal pain or vomiting. If the patient is not tolerating either solid or liquid meals, tube feedings should be considered.

All protocol required laboratory testing, except biomarker and pharmacokinetic (PK) samples, will be performed at the local laboratory. Results from the biomarkers and PK blood samples collected as part of the protocol and being tested at a central lab will not be available to assist the Principal Investigator (PI) or treating physician in managing the patient. 
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