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NCT03709342 · ClinicalTrials.gov registry record · Phase 2
A PK/PD Study of CM4620-IE in Patients With Acute Pancreatitis
A Phase 2 study, sponsored by CalciMedica.
- Completed
- Registry status
- Phase 2
- Development phase
- 7
- Enrollment target
NCT03709342: Completed Phase 2 study, sponsored by CalciMedica.
NCT03709342 is a Phase 2 study that has completed, run by CalciMedica. The registered enrollment target is 7 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (95% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03709342, a Phase 2 study, has completed, sponsored by CalciMedica.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 7 participants
- Enrollment target
Study 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. 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.
Primary Outcome
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.
Interventions
- DRUG CM4620-IE
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 7 participants |
| Start Date | 2019-01-06 |
| Est. Completion | 2019-06-07 |
| Phase | Phase 2 |
What the finished NCT03709342 record still lists
NCT03709342 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 7 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (95% lower).
The record links to 0 conditions, and to 1 intervention - of which CM4620-IE is the first listed.
NCT03709342 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03709342 about?
NCT03709342 is a clinical study titled "A PK/PD Study of 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 ...
What is the current status of trial NCT03709342?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 7 participants. The study started on 2019-01-06. Estimated completion is 2019-06-07.
What interventions are being tested in trial NCT03709342?
The interventions under investigation include: CM4620-IE (DRUG).
Who is sponsoring clinical trial NCT03709342?
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 NCT03709342's enrollment target sits among peer trials
7 1996th of 2000 higher than 5 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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