Ragweed-SPIRE Follow-On Study | NCT02396680

Studies
Ragweed-SPIRE Follow-On Study

NCT02396680

Sponsor

Circassia Limited

Status

Completed

Last Update Posted

Mar 23, 2016Estimated

Enrollment

249Actual

Phase

Not provided

Conditions

Rhinoconjunctivitis
Ragweed Allergy

Interventions

Not provided

Countries

Canada

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

Mar 2016

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

Apr 2015

Primary Completion Date

Feb 2016Actual

Completion Date

Not provided

First Submitted Date

Mar 19, 2015

First Submission Date that Met QC Criteria

Mar 23, 2015

First Posted Date

Mar 24, 2015Estimated

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

Mar 22, 2016

Last Update Posted Date

Mar 23, 2016Estimated

Name	Class
Adiga Life Sciences, Inc.	INDUSTRY

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

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

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

249Actual

Label	Type	Description	Intervention Names
TR006 Subjects		Subjects that have previously been randomised into study TR006

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Total Rhinoconjunctivitis Symptom Score		Approximately 12 months after first dose in TR006

Secondary Outcomes

Measure	Description	Time Frame
Rescue Medication Score		Approximately 12 months after first dose in TR006
Patient Global Assessment		Approximately 12 months after first dose in TR006
Skin Prick Test

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

° Previously randomised into and completed at least 6 of 8 treatment visits in Study TR006

Exclusion Criteria:

Subject or Investigator have been informed of treatment received in Study TR006
Subjects with significant allergy to animal dander
Any allergen immunotherapy since completing Study TR006 or use of prohibited therapies
History of recurrent acute sinusitis or chronic sinusitis
Received treatment with an investigational drug within 4 weeks of Screening
Unable to understand study requirements or unable to communicate clearly with Investigator

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Subjects who completed at least 6 of 8 treatment visits in Study TR006

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Kanata Allergy Services		Kanata	Ontario	K2L 3C8	Canada
Inflamax Research