Effect of an Allergen Vaccine in Patients With Allergic R... | NCT00652223

Studies
Effect of an Allergen Vaccine in Patients With Allergic Rhino-Conjunctivitis and Asthma Due to House Dust Mite Allergy

NCT00652223

Sponsor

Cytos Biotechnology AG

Status

Completed

Last Update Posted

Apr 9, 2008Estimated

Enrollment

21Actual

Phase

Phase 1Phase 2

Conditions

Perennial Allergic Rhinoconjunctivitis
Allergic Asthma

Interventions

CYT005-AllQbG10

Countries

Switzerland

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

Apr 2008

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

Mar 2005

Primary Completion Date

Not provided

Completion Date

Nov 2005Actual

First Submitted Date

Apr 1, 2008

First Submission Date that Met QC Criteria

Apr 1, 2008

First Posted Date

Apr 3, 2008Estimated

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

Apr 4, 2008

Last Update Posted Date

Apr 9, 2008Estimated

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 the study is to test the safety, tolerability, immunogenicity and clinical efficacy of the combination treatment AllQbG10 in patients with rhino-conjunctivitis and asthma due to house dust mite allergy in a single-center, open-label setting.

Detailed Description

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 1Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

21Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Experimental		Biological: CYT005-AllQbG10

Interventions

Name	Type	Description	Arm Group Labels	Other Names
CYT005-AllQbG10	Biological	Immunomodulator CYT003-QbG10 in combination with commercial house dust mite extract as used for routine SIT	1

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Mild to moderate perennial allergic rhinoconjunctivitis due to sensitization against house dust mites
Mild asthma
Females only if non-reproductive or agree to practice an effective and accepted method of contraception

Exclusion Criteria:

Relevant cardiovascular, renal, pulmonary or endocrine disease
History of autoimmune disease
Severe allergies
History of active infectious disease
Current diagnosis or history of malignancy
Relevant neurological or psychiatric disorder
Pregnancy or lactation
History of alcohol abuse or other recreational drugs
Use of an investigational drug within three month before enrolment
Blood donation within 30 days before enrolment

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
Philipp Mueller, MD	Cytos Biotechnology AG	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University Hospital Zurich, Department of Dermatology		Zurich	Canton of Zurich	8091	Switzerland