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

This study has been completed.

Sponsor:

Information provided by:

Cytos Biotechnology AG

ClinicalTrials.gov Identifier:

NCT00652223

First received: April 1, 2008

Last updated: April 4, 2008

Last verified: April 2008

History of Changes

Tracking Information

First Received Date ^ICMJE

April 1, 2008

Last Updated Date

April 4, 2008

Start Date ^ICMJE

March 2005

Primary Completion Date

Not Provided

Current Primary Outcome Measures ^ICMJE

Not Provided

Original Primary Outcome Measures ^ICMJE

Not Provided

Change History

Complete list of historical versions of study NCT00652223 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

Safety, Immunogenicity and Clinical Efficacy of an Allergen Vaccine (AllQbG10) in Subjects With Allergic Rhino-Conjunctivitis and Asthma Due to House Dust Mite Allergy

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

Study Type ^ICMJE

Interventional

Study Phase

Phase 1
Phase 2

Study Design ^ICMJE

Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

Perennial Allergic Rhinoconjunctivitis
Allergic Asthma

Intervention ^ICMJE

Biological: CYT005-AllQbG10

Immunomodulator CYT003-QbG10 in combination with commercial house dust mite extract as used for routine SIT

Study Arm (s)

Experimental: 1

Intervention: Biological: CYT005-AllQbG10

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

November 2005

Primary Completion Date

Not Provided

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years to 55 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Switzerland

Administrative Information

NCT Number ^ICMJE

NCT00652223

Other Study ID Numbers ^ICMJE

CYT005-AllQbG10 01

Has Data Monitoring Committee

Responsible Party

Not Provided

Study Sponsor ^ICMJE

Cytos Biotechnology AG

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Director:

Philipp Mueller, MD

Cytos Biotechnology AG

Information Provided By

Cytos Biotechnology AG

Verification Date

April 2008

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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