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

April 1, 2008
April 4, 2008
March 2005
Not Provided
Not Provided
Not Provided
Complete list of historical versions of study NCT00652223 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Effect of an Allergen Vaccine in Patients With Allergic Rhino-Conjunctivitis and Asthma Due to House Dust Mite Allergy
Safety, Immunogenicity and Clinical Efficacy of an Allergen Vaccine (AllQbG10) in Subjects With Allergic Rhino-Conjunctivitis and Asthma Due to House Dust Mite Allergy

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.

Not Provided
Interventional
Phase 1
Phase 2
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Perennial Allergic Rhinoconjunctivitis
  • Allergic Asthma
Biological: CYT005-AllQbG10
Immunomodulator CYT003-QbG10 in combination with commercial house dust mite extract as used for routine SIT
Experimental: 1
Intervention: Biological: CYT005-AllQbG10
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
21
November 2005
Not Provided

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
Both
18 Years to 55 Years
No
Contact information is only displayed when the study is recruiting subjects
Switzerland
 
NCT00652223
CYT005-AllQbG10 01
No
Not Provided
Cytos Biotechnology AG
Not Provided
Study Director: Philipp Mueller, MD Cytos Biotechnology AG
Cytos Biotechnology AG
April 2008

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