CM4620 Injectable Emulsion Versus Supportive Care in Patients With Acute Pancreatitis and SIRS
Public ClinicalTrials.gov record NCT03401190. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
An Open-Label, Dose-Response Study of CM4620 Injectable Emulsion (CM4620-IE) in Patients With Acute Pancreatitis and Accompanying Systemic Inflammatory Response Syndrome (SIRS)
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
This open-label, dose-response study will evaluate the safety and efficacy of CM4620-IE in patients with acute pancreatitis and accompanying SIRS. The study will consist of two phases. The first phase will consist of 4 female and 4 male patients (cohorts 1 and 2, respectively), enrolled concurrently, randomized in a 3:1 ratio to receive CM4620-IE plus standard of care versus standard of care alone. Planned doses for first phase will be CM4620-IE 1.0 mg/kg on Day 1 and then 1.4 mg/kg on Days 2 - 4. The second phase will consist of 8 female and 8 male patients (cohorts 3 and 4, respectively), enrolled concurrently, randomized in a 3:1 ratio to receive CM4620-IE plus standard of care versus standard of care alone. Planned doses for second phase will be CM4620-IE 2.08 mg/kg on Days 1 and 2 and then 1.6 mg/kg on Days 3 and 4. Dose escalation to second phase would only occur if needed for efficacy reasons and if no events suggesting a safety signal would occur with higher dosing. The study is not powered for the analysis of study data with inferential statisitcs as the primary purpose of the study is to explore what endpoints would be most appropriate for future trials.
Study identification
- NCT ID
- NCT03401190
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 21 participants
Conditions and interventions
Interventions
Drug
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Mar 12, 2018 (Actual)
- Primary completion
- Feb 14, 2019 (Actual)
- Completion
- Apr 30, 2019 (Actual)
- Last update posted
- Mar 30, 2026
2018 – 2019
United States locations
- U.S. sites
- 9
- U.S. states
- 5
- U.S. cities
- 7
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Detroit Receiving Hospital (Wayne State) | Detroit | Michigan | 48201 | — |
| Henry Ford Hospital | Detroit | Michigan | 48202 | — |
| Sinai-Grace Hospital (Wayne State) | Detroit | Michigan | 48235 | — |
| Hennepin County Medical Center | Minneapolis | Minnesota | 55415 | — |
| Regions Hospital | Saint Paul | Minnesota | 55101 | — |
| Washington University | St Louis | Missouri | 63110 | — |
| MetroHealth (Case Western) | Cleveland | Ohio | 44109 | — |
| Riverside Methodist | Columbus | Ohio | 43214 | — |
| Ben Taub (Baylor College of Medicine) | Houston | Texas | 77030 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT03401190, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Mar 30, 2026 · Synced Oct 25, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT03401190 live on ClinicalTrials.gov.