Ignite Creation Date:
2024-05-06 @ 9:13 AM
Last Modification Date:
2024-10-26 @ 12:11 PM
Study NCT ID:
NCT02927431
Status:
TERMINATED
Last Update Posted:
2020-11-30
First Post:
2016-09-29
Brief Title:
Study to Evaluate the Efficacy and Safety of Danirixin Co-administered With Oseltamivir in the Treatment of Adults Hospitalized With Influenza
Sponsor:
GlaxoSmithKline
Organization:
GlaxoSmithKline
Study Overview
Official Title:
A Phase II Global Randomized Study to Evaluate the Efficacy and Safety of Danirixin GSK1325756 Co-administered With a Standard-of-care Antiviral Oseltamivir in the Treatment of Adults Hospitalized With Influenza
Status:
TERMINATED
Status Verified Date:
2020-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
The study was stopped early due to lack of enrollment
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 221 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 enhanced safety monitoring in sentinel cohorts leading to stepwise enrollment of subjects Subjects will be enrolled based on increasing levels of renal impairment and less severe hospitalized subjects will be enrolled prior to enrollment of critically ill subjects as this is the first study conducted in the hospitalized population with severe IFV Approximately 300 subjects are targeted to be enrolled in the study
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2016-002512-40 | EUDRACT_NUMBER | None | None |