Expired Study
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Detroit, Michigan 48202


Purpose:

This open-label study will evaluate the pharmacodynamic and pharmacokinetic profile of CM4620-IE in patients with acute pancreatitis. The first five (5) patients will receive ≤ 2.08 mg/kg of CM4620-IE by continuous IV infusion on Day 1. If necessary, up to an additional 4 patients may be treated at a different dose of CM4620-IE as determined by the obtained PK and PD data. The infusion of CM4620-IE will start within 12 hours from the time the patient or LAR provides informed consent.


Criteria:

Inclusion Criteria: 1. Diagnosis of acute pancreatitis established by the presence of abdominal pain consistent with acute pancreatitis, and 1 of the following 2 criteria: 1. Serum lipase and/or serum amylase > 3 times the upper limit of normal (ULN); 2. Characteristic findings of acute pancreatitis on abdominal imaging; 2. Adults ≥ 18 years of age; 3. A female patient of child-bearing potential who is sexually active with a male partner must be willing to practice acceptable methods of birth control for 365 days after the last dose of CM4620-IE; 4. A male patient who is sexually active with a female partner of childbearing potential must be willing to practice acceptable methods of birth control for 365 days after the last dose of CM4620-IE and must not donate sperm for 365 days; 5. Willing and able to, or have a legal authorized representative (LAR) who is willing and able to, provide informed consent to participate, and cooperate with all aspects of the protocol. Exclusion Criteria: 1. Any concurrent clinical condition that a study physician believes could potentially pose an unacceptable health risk to the patient while involved in the study or may limit expected survival to < 6 months; 2. Suspected presence of cholangitis in the judgment of the treating investigator; 3. Any malignancy being treated with chemotherapy or immunotherapy; 4. Any autoimmune disease being treated with immunosuppressive medication or immunotherapy (Section 5.3 for list of prohibited medications); 5. History of: 1. Chronic pancreatitis, pancreatic necrosectomy, or pancreatic enzyme replacement therapy; 2. Biopsy proven cirrhosis, portal hypertension, hepatic failure/hepatic encephalopathy; 3. Known hepatitis B or C, or HIV; 4. History of organ or hematologic transplant; 5. Myocardial infarction, revascularization, cardiovascular accident (CVA) in the 30 days prior to Day 1; 6. Current renal replacement therapy; 7. Current known abuse of cocaine or methamphetamine; 8. Known to be pregnant or are nursing; 9. Participated in another study of an investigational drug or therapeutic medical device in the 30 days prior to Day 1; 10. History of allergy to eggs or known hypersensitivity to any components of CM4620-IE; 11. Prior treatment with CM4620-IE.


NCT ID:

NCT03709342


Primary Contact:

Study Director
Sudarshan Hebbar, MD
CalciMedica, Inc.


Backup Contact:

N/A


Location Contact:

Detroit, Michigan 48202
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: October 09, 2019

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