Safety and Efficacy of House Dust Mite Allergen Extract i... | NCT00263549

Studies
Safety and Efficacy of House Dust Mite Allergen Extract in the Treatment of Allergic Rhinoconjunctivitis

NCT00263549

Sponsor

Allergopharma GmbH & Co. KG

Status

Completed

Last Update Posted

Feb 11, 2013Estimated

Enrollment

Not provided

Phase

Phase 4

Conditions

House Dust Mite Allergy

Interventions

House dust mite Novo Helisen Depot

Countries

Germany

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

Feb 2013

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

Sep 2002

Primary Completion Date

Feb 2005Actual

Completion Date

Feb 2006Actual

First Submitted Date

Dec 8, 2005

First Submission Date that Met QC Criteria

Dec 8, 2005

First Posted Date

Dec 9, 2005Estimated

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

Feb 8, 2013

Last Update Posted Date

Feb 11, 2013Estimated

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

Interventional

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

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

Not provided

Name	Type	Description	Arm Group Labels	Other Names
House dust mite Novo Helisen Depot	Biological

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Positive skin prick test to house dust mite,
Positive RAST test to house dust mite,
Positive provocation test result to house dust mite,

Exclusion Criteria:

Serious chronic diseases,
Other perennial allergies

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

55 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Annemie Narkus, M.D.		Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Allergopharma GmbH & Co. KG		Reinbek		21465	Germany

Label	URL
Leader in specific allergy research and therapy	View source

Condition Browse Module

MeSH Terms

ID	Term
D000092542	Dust Mite Allergy
D006967	Hypersensitivity

Ancestor Terms

ID	Term
D012221	Rhinitis, Allergic, Perennial
D065631	Rhinitis, Allergic
D012220	Rhinitis
D009668	Nose Diseases

Browse Leaves

Not provided

Browse Branches

Not provided