Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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 is a Phase 2 study that has completed, run by CalciMedica. The registered enrollment target is 21 participants.
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.
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03401190
The ClinicalTrials.gov registry entry for NCT03401190 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 21 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is CalciMedica, which has 6 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which CM4620 Injectable Emulsion (Low Dose) is the first listed.
NCT03401190 reports 0 study locations.
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
Explore more on PlainTrial
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.