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NCT03354754 · ClinicalTrials.gov registry record · Phase 2
LYS228 PK, Clinical Response, Safety and Tolerability in Patients With Complicated Intra-abdominal Infection (cIAI)
A Phase 2 study, sponsored by Novartis Pharmaceuticals.
- Terminated
- Registry status
- Phase 2
- Development phase
- 3
- Enrollment target
NCT03354754 is a Phase 2 study that was terminated before completion, run by Novartis Pharmaceuticals. The registered enrollment target is 3 participants.
The verdict
NCT03354754, a Phase 2 study, was terminated before completion, sponsored by Novartis Pharmaceuticals.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 3 participants
- Enrollment target
Study Summary
The purpose of the study was to evaluate whether LYS228 can be developed for the treatment of complicated intra-abdominal infections. It was planned that LYS228 exposure across patients with varying renal function would be evaluated during the study to confirm that LYS228 concentrations are predicted to be adequate to treat the patient population. It was planned that the PK exposure of the initial 8 patients would be analyzed. PK analysis was not conducted as per protocol the first analysis required 8 patients.
Interventions
- DRUG LYS228
- DRUG Standard of care therapy
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 3 participants |
| Start Date | 2018-05-15 |
| Est. Completion | 2018-09-24 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03354754
The ClinicalTrials.gov registry entry for NCT03354754 describes a study currently listed as terminated, categorized as Phase 2. The registered enrollment target is 3 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Novartis Pharmaceuticals, which has 1,375 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which LYS228 is the first listed.
NCT03354754 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03354754 about?
NCT03354754 is a clinical study titled "LYS228 PK, Clinical Response, Safety and Tolerability in Patients With Complicated Intra-abdominal Infection (cIAI)". The purpose of the study was to evaluate whether LYS228 can be developed for the treatment of complicated intra-abdominal infections. It was planned that LYS228 exposure across patients with varying renal function would be evaluated during the study to confirm that LYS228 concentrations are predict...
What is the current status of trial NCT03354754?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 3 participants. The study started on 2018-05-15. Estimated completion is 2018-09-24.
What interventions are being tested in trial NCT03354754?
The interventions under investigation include: LYS228 (DRUG), Standard of care therapy (DRUG).
Who is sponsoring clinical trial NCT03354754?
This trial is sponsored by Novartis Pharmaceuticals, which has 1,375 total clinical trials registered on ClinicalTrials.gov.
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