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NCT03401190 · ClinicalTrials.gov registry record · Phase 2
CM4620 Injectable Emulsion Versus Supportive Care in Patients With Acute Pancreatitis and SIRS
A Phase 2 study, sponsored by CalciMedica.
- Completed
- Registry status
- Phase 2
- Development phase
- 21
- Enrollment target
NCT03401190: Completed Phase 2 study, sponsored by CalciMedica.
NCT03401190 is a Phase 2 study that has completed, run by CalciMedica. The registered enrollment target is 21 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (84% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03401190, a Phase 2 study, has completed, sponsored by CalciMedica.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 21 participants
- Enrollment target
Study Summary
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.
Primary Outcome
Safety and tolerability will be assessed by monitoring the frequency, duration and severity of treatment-emergent adverse events (TEAEs) throughout the study period.
Interventions
- DRUG CM4620 Injectable Emulsion (Low Dose)
- DRUG CM4620 Injectable Emulsion (High Dose)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 21 participants |
| Start Date | 2018-03-12 |
| Est. Completion | 2019-04-30 |
| Phase | Phase 2 |
What the finished NCT03401190 record still lists
NCT03401190 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 21 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (84% lower).
The record links to 0 conditions, and to 2 interventions - of which CM4620 Injectable Emulsion (Low Dose) is the first listed.
NCT03401190 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03401190 about?
NCT03401190 is a clinical study titled "CM4620 Injectable Emulsion Versus Supportive Care in Patients With Acute Pancreatitis and SIRS". 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...
What is the current status of trial NCT03401190?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 21 participants. The study started on 2018-03-12. Estimated completion is 2019-04-30.
What interventions are being tested in trial NCT03401190?
The interventions under investigation include: CM4620 Injectable Emulsion (Low Dose) (DRUG), CM4620 Injectable Emulsion (High Dose) (DRUG).
Who is sponsoring clinical trial NCT03401190?
This trial is sponsored by CalciMedica, which has 6 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03401190's enrollment target sits among peer trials
21 1794th of 2000 higher than 196 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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