Trial · NCT03401190
CM4620 Injectable Emulsion Versus Supportive Care in Patients With Acute Pancreatitis and SIRS
NCT03401190, Phase 2, Completed, CalciMedica, Inc.; results first posted 2021-12-07
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. CM4620 Injectable Emulsion Versus Supportive Care in Patients With Acute Pancreatitis and SIRS. Trials, record NCT03401190. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03401190
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- CM4620 Injectable Emulsion Versus Supportive Care in Patients With Acute Pancreatitis and SIRS
- NCT number
- NCT03401190
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 21 participants, actual
- Lead sponsor
- CalciMedica, Inc.
- Conditions
- Acute Pancreatitis, Systemic Inflammatory Response Syndrome
- Interventions
- CM4620 Injectable Emulsion (Low Dose), CM4620 Injectable Emulsion (High Dose)
- First posted
- 2018-01-17
- Last updated
- 2026-03-30
- Results first posted
- 2021-12-07
Source ClinicalTrials.gov
Registered outcomes7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | The Safety and Tolerability of CM4620-IE in Patients With Acute Pancreatitis and Accompanying Systemic Inflammatory Response Syndrome (SIRS) or Hypoxemia. | 90 Days | Safety and tolerability will be assessed by monitoring the frequency, duration and severity of treatment-emergent adverse events (TEAEs) throughout the study period. |
| Secondary | The Number of Patients With a Change in Computed Tomography Severity Index (CTSI) Score Between Screening and Day 5 (or Discharge, if Earlier) | 5 days (or discharge, if earlier) | CTSI score measures abnormal pancreatic morphology and is the sum of two subscales. The Balthazar subscale rates pancreatic CT image findings on a scale of 0 (normal) to 4 (2 or more peri-pancreatic fluid collections. The Pancreatic Necrosis subscale rates pancreatic necrosis from 0 (none) to 6 (\>50%). The two subscales are summed for a CTSI score of 0-3 (mild AP), 4-6 (moderate AP), and 7-10 (severe AP). |
| Secondary | The Number of Patients Tolerating Solid Food | at 72 hours (or discharge, if earlier) | Defined as eating ≥ 50% of a solid meal without vomiting or an increase in pain |
| Secondary | The Number of Patients Tolerating Solid Food | at Day 10 (or discharge, if earlier) | Defined as eating ≥ 50% of a solid meal without vomiting or an increase in pain |
| Secondary | Percentage of Patients With Persistent Systemic Inflammatory Response Syndrome (SIRS) | ≥ 48 hours | The presence of SIRS was defined as the presence of at least 2 of the following 4 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 cells/mm3 or \< 4,000 cells/mm3 or \> 10% immature (band) forms. * The SIRS score was determined at Screening, prior to randomization, and every 12 hours until Day 6, after which it was determined every 24 hours. |
| Secondary | IL-6 Values in Patients With a Maximum IL-6 Value ≥ 150 pg/mL in the First 24 Hours | Day 10 (or discharge, if earlier) | Assess blood serum samples to be analyzed for interleuken (IL-6) llevels pg/mL collected in the first 24 hours and daily thereafter. Samples were sent to the central laboratory. The results were not provided to the Principal Investigator or treating physician. |
| Secondary | Median Days in Hospital | discharge | Length of stay in hospital in days (randomization to discharge) |
Source ClinicalTrials.gov
Outcomes7
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | The Safety and Tolerability of CM4620-IE in Patients With Acute Pancreatitis and Accompanying Systemic Inflammatory Response Syndrome (SIRS) or Hypoxemia. | 90 Days | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | The Number of Patients With a Change in Computed Tomography Severity Index (CTSI) Score Between Screening and Day 5 (or Discharge, if Earlier) | 5 days (or discharge, if earlier) | One patient treated with the high dose regimen+SC did not receive a CTSI score at either the Screening or Day 5 or Discharge CECTs. One patient treated with SC alone did not receive a CTSI score at Screening because contrast was not given. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | The Number of Patients Tolerating Solid Food | at 72 hours (or discharge, if earlier) | number of patients tolerating solid food | NUMBER | |
| SECONDARY | The Number of Patients Tolerating Solid Food | at Day 10 (or discharge, if earlier) | number of patients tolerating solid food | NUMBER | |
| SECONDARY | Percentage of Patients With Persistent Systemic Inflammatory Response Syndrome (SIRS) | ≥ 48 hours | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | IL-6 Values in Patients With a Maximum IL-6 Value ≥ 150 pg/mL in the First 24 Hours | Day 10 (or discharge, if earlier) | Only patients with a maximum IL-6 value ≥ 150 pg/mL in the first 24 hours were analyzed. Further, since some patients IL-6 values decreased below 150 pg/mL, they are not displayed in the results table. Analysis only included patients who still had IL-6 values ≥ 150 pg/mL at Day 10 or discharge (whichever was earlier). | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Median Days in Hospital | discharge | days | MEDIAN |
Source ClinicalTrials.gov
Results by group60
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| The Safety and Tolerability of CM4620-IE in Patients With Acute Pancreatitis and Accompanying Systemic Inflammatory Response Syndrome (SIRS) or Hypoxemia. | Low Dose Group + SC | TEAE patients | 7 | Participants | |
| The Safety and Tolerability of CM4620-IE in Patients With Acute Pancreatitis and Accompanying Systemic Inflammatory Response Syndrome (SIRS) or Hypoxemia. | High Dose Group + SC | TEAE patients | 5 | Participants | |
| The Safety and Tolerability of CM4620-IE in Patients With Acute Pancreatitis and Accompanying Systemic Inflammatory Response Syndrome (SIRS) or Hypoxemia. | Standard of Care Group (SC) | TEAE patients | 3 | Participants | |
| The Safety and Tolerability of CM4620-IE in Patients With Acute Pancreatitis and Accompanying Systemic Inflammatory Response Syndrome (SIRS) or Hypoxemia. | Low Dose Group + SC | Severe TEAE patients | 0 | Participants | |
| The Safety and Tolerability of CM4620-IE in Patients With Acute Pancreatitis and Accompanying Systemic Inflammatory Response Syndrome (SIRS) or Hypoxemia. | High Dose Group + SC | Severe TEAE patients | 2 | Participants | |
| The Safety and Tolerability of CM4620-IE in Patients With Acute Pancreatitis and Accompanying Systemic Inflammatory Response Syndrome (SIRS) or Hypoxemia. | Standard of Care Group (SC) | Severe TEAE patients | 2 | Participants | |
| The Safety and Tolerability of CM4620-IE in Patients With Acute Pancreatitis and Accompanying Systemic Inflammatory Response Syndrome (SIRS) or Hypoxemia. | Low Dose Group + SC | SAE patients | 2 | Participants | |
| The Safety and Tolerability of CM4620-IE in Patients With Acute Pancreatitis and Accompanying Systemic Inflammatory Response Syndrome (SIRS) or Hypoxemia. | High Dose Group + SC | SAE patients | 1 | Participants | |
| The Safety and Tolerability of CM4620-IE in Patients With Acute Pancreatitis and Accompanying Systemic Inflammatory Response Syndrome (SIRS) or Hypoxemia. | Standard of Care Group (SC) | SAE patients | 2 | Participants | |
| The Safety and Tolerability of CM4620-IE in Patients With Acute Pancreatitis and Accompanying Systemic Inflammatory Response Syndrome (SIRS) or Hypoxemia. | Low Dose Group + SC | TEAEs leading to discontinuation | 0 | Participants |
1 to 10 of 60Source ClinicalTrials.gov
See all 60 results by groupParticipant flow9
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Low Dose Group | 8 | |
| Overall Study | STARTED | High Dose Group | 6 | |
| Overall Study | STARTED | Standard of Care Group | 7 | |
| Overall Study | COMPLETED | Low Dose Group | 8 | |
| Overall Study | COMPLETED | High Dose Group | 4 | |
| Overall Study | COMPLETED | Standard of Care Group | 7 | |
| Overall Study | NOT COMPLETED | Low Dose Group | 0 | |
| Overall Study | NOT COMPLETED | High Dose Group | 2 | |
| Overall Study | NOT COMPLETED | Standard of Care Group | 0 |
Source ClinicalTrials.gov
Adverse events162
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Electrolyte imbalance | Metabolism and nutrition disorders | Low Dose Group | 0 | 8 | 0 |
| other | Electrolyte imbalance | Metabolism and nutrition disorders | High Dose Group | 1 | 6 | 1 |
| other | Electrolyte imbalance | Metabolism and nutrition disorders | Standard of Care Group | 0 | 7 | 0 |
| other | Fluid Overload | Metabolism and nutrition disorders | Low Dose Group | 0 | 8 | 0 |
| other | Fluid Overload | Metabolism and nutrition disorders | High Dose Group | 1 | 6 | 1 |
| other | Fluid Overload | Metabolism and nutrition disorders | Standard of Care Group | 1 | 7 | 1 |
| other | Fluid retention | Metabolism and nutrition disorders | Low Dose Group | 0 | 8 | 0 |
| other | Fluid retention | Metabolism and nutrition disorders | High Dose Group | 1 | 6 | 1 |
| other | Fluid retention | Metabolism and nutrition disorders | Standard of Care Group | 0 | 7 | 0 |
| other | Hyperglycemia | Metabolism and nutrition disorders | Low Dose Group | 0 | 8 | 0 |
1 to 10 of 162Source ClinicalTrials.gov
See all 162 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Low Dose Group | 0 | 8 |
| Total, all-cause mortality | High Dose Group | 1 | 6 |
| Total, all-cause mortality | Standard of Care Group | 0 | 7 |
| Total, other adverse events | Low Dose Group | 7 | 8 |
| Total, other adverse events | High Dose Group | 5 | 6 |
| Total, other adverse events | Standard of Care Group | 3 | 7 |
| Total, serious adverse events | Low Dose Group | 2 | 8 |
| Total, serious adverse events | High Dose Group | 1 | 6 |
| Total, serious adverse events | Standard of Care Group | 2 | 7 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 33939666 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT03401190
GET https://conductscience.org/api/trials/v1/NCT03401190/results?page=2