Special Drug Use Investigation for Relenza® (Zanamivir) (... | NCT01390792

Studies
Special Drug Use Investigation for Relenza® (Zanamivir) (Prophylaxis)

NCT01390792

Sponsor

GlaxoSmithKline

Status

Completed

Last Update Posted

May 16, 2017Actual

Enrollment

622Actual

Phase

Not provided

Conditions

Influenza, Human

Interventions

Zanamivir hydrate

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2017

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2007

Primary Completion Date

Feb 2009Actual

Completion Date

May 2009Actual

First Submitted Date

Jul 7, 2011

First Submission Date that Met QC Criteria

Jul 7, 2011

First Posted Date

Jul 11, 2011Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 15, 2017

Last Update Posted Date

May 16, 2017Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The purpose of this post-marketing surveillance study is to collect information on efficacy and safety for prophylactic administration of zanamivir in clinical practice in family or persons living with patients with influenza virus infection.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

622Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Subjects prescribed zanamivir		Subjects prescribed zanamivir during study period	Drug: Zanamivir hydrate

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Zanamivir hydrate	Drug		Subjects prescribed zanamivir

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
The number of incidence of adverse events in subjects treated with zanamivir		11 days
Occurrence of influenza virus infection		11 days

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Subjects who meet the study population criteria

Exclusion Criteria:

Subjects with a history of hypersensitivity to the ingredients of zanamivir

Accepts Healthy Volunteers

Not provided

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

<Zanamivir prophylactic administration group> Subjects meeting all of the following criteria and starting prophylactic administration of zanamivir

family or persons living with patients with influenza virus infection
subjects meeting any of the following criteria, elderly subjects ( 65 years old and over), subjects with chronic cardiac disease, with metabolic disease (diabetes, etc.) or with renal dysfunction
unvaccinated persons during the applicable seasons
subjects whose consent to write influenza diary was obtained

<Non-zanamivir prophylactic administration group>

- subjects meeting all of the above criteria and NOT starting prophylactic administration of zanamivir

Sampling Method

Probability Sample

Name	Affiliation	Role
GSK Clinical Trials	GlaxoSmithKline	Study Director

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
	Background	Keizo Matsumoto, Hideyuki Okano, Naomi Hasegawa, Ichiro Ohwaki, Shogo Inoshiri. Study on Preventive Effects of Zanamivir (Relenza) for Influenza. Medicine and Drug Journal. 2010;46(11):121-132.

ID	Term
D012141	Respiratory Tract Infections
D007239	Infections
D009976	Orthomyxoviridae Infections
D012327	RNA Virus Infections