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NCT02927431 · ClinicalTrials.gov registry record · Phase 2
Study to Evaluate the Efficacy and Safety of Danirixin Co-administered With Oseltamivir in the Treatment of Adults Hospitalized With Influenza
A Phase 2 study, sponsored by GlaxoSmithKline.
- Terminated
- Registry status
- Phase 2
- Development phase
- 10
- Enrollment target
NCT02927431 is a Phase 2 study that was terminated before completion, run by GlaxoSmithKline. The registered enrollment target is 10 participants.
The verdict
NCT02927431, a Phase 2 study, was terminated before completion, sponsored by GlaxoSmithKline.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 10 participants
- Enrollment target
Study Summary
Danirixin (DNX) is a novel, selective, and reversible antagonist of the C-X-C chemokine receptor (CXCR) 2 and has been shown to decrease neutrophil transmigration and activation to areas of inflammation. An intravenous (IV) formulation of DNX hydrobromide (HBr) is being developed as an anti-inflammatory agent for treatment of adults hospitalized with influenza (IFV). While early therapy with antivirals decreases severity and duration of symptoms of influenza, there are no drugs that have demonstrated clinical efficacy in randomized clinical trials in this population. Current treatment guidelines for hospitalized IFV recommend neuraminidase inhibitors as standard of care therapy. IFV studies in animals have demonstrated that therapeutic treatment with the combination of a CXCR2 antagonist and a neuraminidase inhibitor reduced lung neutrophils and showed trends for improvements in clinical scores, lung function and pathology with no evidence of worsening outcomes, including viral load. This Phase 2, randomized, double-blind (for IV DNX), placebo-controlled (for IV DNX) 3-arm study will be the first study to determine the efficacy and safety of IV DNX when co-administered (in all groups) with standard of care antiviral treatment (open-label oral oseltamivir \[OSV\]) in subjects hospitalized with IFV. The primary objective of the study is to assess the efficacy of treatment with IV DNX twice daily given with oral OSV compared to oral OSV twice daily on time to clinical response (TTCR). In this study, subjects will be randomized in a 2:2:1 ratio to 15 milligram (mg) free base equivalent (FBE) IV DNX, 50 mg FBE IV DNX, or matching placebo twice daily. All subjects will also receive open-label 75 mg oral OSV, twice daily (given as standard of care). The study treatment duration will be for up to 5 days. The investigator may elect to continue treatment with OSV after 5 days of study treatment. Follow up will continue until Day 45 for all subjects. The study will begin with
Interventions
- DRUG Placebo
- DRUG Oseltamivir 75 mg
- DRUG Danirixin 15 mg FBE
- DRUG Danirixin 50 mg FBE
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 10 participants |
| Start Date | 2017-01-19 |
| Est. Completion | 2017-05-24 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02927431
The ClinicalTrials.gov registry entry for NCT02927431 describes a study currently listed as terminated, categorized as Phase 2. The registered enrollment target is 10 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is GlaxoSmithKline, which has 1,345 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 4 interventions - of which Placebo is the first listed.
NCT02927431 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02927431 about?
NCT02927431 is a clinical study titled "Study to Evaluate the Efficacy and Safety of Danirixin Co-administered With Oseltamivir in the Treatment of Adults Hospitalized With Influenza". Danirixin (DNX) is a novel, selective, and reversible antagonist of the C-X-C chemokine receptor (CXCR) 2 and has been shown to decrease neutrophil transmigration and activation to areas of inflammation. An intravenous (IV) formulation of DNX hydrobromide (HBr) is being developed as an anti-inflamma...
What is the current status of trial NCT02927431?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 10 participants. The study started on 2017-01-19. Estimated completion is 2017-05-24.
What interventions are being tested in trial NCT02927431?
The interventions under investigation include: Placebo (DRUG), Oseltamivir 75 mg (DRUG), Danirixin 15 mg FBE (DRUG), Danirixin 50 mg FBE (DRUG).
Who is sponsoring clinical trial NCT02927431?
This trial is sponsored by GlaxoSmithKline, which has 1,345 total clinical trials registered on ClinicalTrials.gov.
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