Acute PancreatitisPhase 2NCT03709342
A PK/PD Study of CM4620-IE in Patients With Acute Pancreatitis
A Phase 2 study testing CM4620-IE in people with Acute Pancreatitis, run by CalciMedica, Inc. at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Pancreatitis
- What is being tested?
- CM4620-IE
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Jan 2019to 7 Jun 2019
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of acute pancreatitis established by the presence of abdominal pain consistent with acute pancreatitis, and 1 of the following 2 criteria:
- Serum lipase and/or serum amylase > 3 times the upper limit of normal (ULN);
- Characteristic findings of acute pancreatitis on abdominal imaging;
- Adults ≥ 18 years of age;
- 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;
- 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;
- 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.
Who cannot join
- 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;
- Suspected presence of cholangitis in the judgment of the treating investigator;
- Any malignancy being treated with chemotherapy or immunotherapy;
- Any autoimmune disease being treated with immunosuppressive medication or immunotherapy (Section 5.3 for list of prohibited medications);
- History of:
- Chronic pancreatitis, pancreatic necrosectomy, or pancreatic enzyme replacement therapy;
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- Biopsy proven cirrhosis, portal hypertension, hepatic failure/hepatic encephalopathy;
- Known hepatitis B or C, or HIV;
- History of organ or hematologic transplant;
- Myocardial infarction, revascularization, cardiovascular accident (CVA) in the 30 days prior to Day 1;
- Current renal replacement therapy;
- Current known abuse of cocaine or methamphetamine;
- Known to be pregnant or are nursing;
- Participated in another study of an investigational drug or therapeutic medical device in the 30 days prior to Day 1;
- History of allergy to eggs or known hypersensitivity to any components of CM4620-IE;
- Prior treatment with CM4620-IE.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Pharmacodynamic and Pharmacokinetic Study of CM4620 Injectable Emulsion (CM4620-IE) in Patients With Acute Pancreatitis
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.
- Conditions
- Acute Pancreatitis
- Being tested
- CM4620-IE
- Medical subject headings
- Pancreatitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CM4620-IEDrug
single IV infusion on Day 1 over 4 hours
| Study group | Role | What they receive |
|---|---|---|
| All Patients | Experimental | Not described Receives: Drug: CM4620-IE |
What is being measured
The primary outcome is the main question the study is designed to answer.
Exploratory: Percentage Change in IL-2 Production Relative to Pre-dose Values
Outcome assessed the percent change in IL-2 production after the administration of a single dose of CM4620-IE as compared to baseline production, for all patients enrolled. This measurement was to explore if there was a change in IL-2 levels with acute pancreatitis after the administration of a single dose of CM4620-IE.
Measured: Predose to 30 minutes post dose
Secondary outcomes (9)
The Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
The number of participants who experienced treatment-emergent adverse events (TEAEs) with Investigator-specified relationship to CM4620-IE and assessment of severity.
Measured: From baseline through 30 days
Pharmacokinetics (CMax of CM4620): Day 1, 30 Minutes Post End-of-infusion
Measured: Days 1, 2, 5, 10 and 30 or at discharge if earlier than day 30
Pharmacokinetics (Plasma Concentration of CM4620): Day 2, 20-hr Post End-of-infusion
Time points for sampling of plasma for bioanalysis of CM4620, blood for PD analysis (stimulated IL-2 release), and serum for cytokine analysis were chosen to capture the expected maximal plasma concentration (Cmax) on Day 1 and times close to the minimum plasma concentration (Cmin) on subsequent days.
Measured: Day 2
Pharmacokinetics (Plasma Concentration of CM4620): Day 10 or Discharge
Measured: Day 10, or day of discharge
Pharmacokinetics (Plasma Concentration of CM4620): Day 30
Measured: Day 30
Baseline Levels of IL-6
Included plasma samples collected 1 hour prior to the study drug administration
Measured: Baseline
Day 1: 30 Minutes Post-infusion IL-6 Levels
Measured: Day 1
Day 2: 20-hr Post Infusion IL-6 Levels
Measured: Day 2
Post-infusion IL-6 Levels at Discharge
This sample was drawn immediately prior to discharge from hospitalization, and ranged from day 2 through day 9.
Measured: Assessed at Discharge, between 2 and 9 days.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2018
- Study start6 Jan 2019
- Primary completion7 Mar 2019
- Study completion7 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Acute PancreatitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- CalciMedica, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Sudarshan Hebbar, MD, Study director, CalciMedica, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03709342
- Sponsor's protocol ID
- CM4620-202
- Status last verified
- Feb 2022
- First submitted
- 11 Oct 2018
- Last updated
- 3 May 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pharmacodynamic and Pharmacokinetic Study of CM4620 Injectable Emulsion (CM4620-IE) in Patients With Acute Pancreatitis
- ClinicalTrials.gov ID
- NCT03709342
- Acronym / sponsor ID
- CM4620-202
- Conditions
- Acute Pancreatitis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 7 participants (actual)
- Lead sponsor
- CalciMedica, Inc.Industry (pharma, biotech, devices)
- Study start
- 6 Jan 2019 (actual)
- Primary completion
- 7 Mar 2019 (actual)
- Study completion
- 7 Jun 2019 (actual)
- First posted
- 17 Oct 2018 (actual)
- Results
- Posted 3 May 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| All Patients | Experimental | Drug: CM4620-IE |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Diagnosis of acute pancreatitis established by the presence of abdominal pain consistent with acute pancreatitis, and 1 of the following 2 criteria:
- Adults ≥ 18 years of age;
- 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;
- 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;
- 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.
Key exclusion criteria (16 listed)
- 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;
- Suspected presence of cholangitis in the judgment of the treating investigator;
- Any malignancy being treated with chemotherapy or immunotherapy;
- Any autoimmune disease being treated with immunosuppressive medication or immunotherapy (Section 5.3 for list of prohibited medications);
- History of:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CM4620-IEsingle IV infusion on Day 1 over 4 hours | Drug | All Patients |
Primary outcome
Exploratory: Percentage Change in IL-2 Production Relative to Pre-dose Values
Time frame: Predose to 30 minutes post dose
Outcome assessed the percent change in IL-2 production after the administration of a single dose of CM4620-IE as compared to baseline production, for all patients enrolled. This measurement was to explore if there was a change in IL-2 levels with acute pancreatitis after the administration of a single dose of CM4620-IE.
9 secondary outcomes
The Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Time frame: From baseline through 30 days
Pharmacokinetics (CMax of CM4620): Day 1, 30 Minutes Post End-of-infusion
Time frame: Days 1, 2, 5, 10 and 30 or at discharge if earlier than day 30
Pharmacokinetics (Plasma Concentration of CM4620): Day 2, 20-hr Post End-of-infusion
Time frame: Day 2
Pharmacokinetics (Plasma Concentration of CM4620): Day 10 or Discharge
Time frame: Day 10, or day of discharge
Pharmacokinetics (Plasma Concentration of CM4620): Day 30
Time frame: Day 30
Baseline Levels of IL-6
Time frame: Baseline
Day 1: 30 Minutes Post-infusion IL-6 Levels
Time frame: Day 1
Day 2: 20-hr Post Infusion IL-6 Levels
Time frame: Day 2
Post-infusion IL-6 Levels at Discharge
Time frame: Assessed at Discharge, between 2 and 9 days.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 May 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sudarshan Hebbar, MD study director
CalciMedica, Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing CM4620-IE in people with Acute Pancreatitis, run by CalciMedica, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 3 May 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Exploratory: Percentage Change in IL-2 Production Relative to Pre-dose Values (time frame: Predose to 30 minutes post dose). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 May 2022.