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Sponsored by: |
Cytos Biotechnology AG |
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Information provided by: | Cytos Biotechnology AG |
ClinicalTrials.gov Identifier: | NCT00574223 |
The purpose of the study is to test the efficacy of the combination treatment AllQbG10 in patients with perennial allergic rhinoconjunctivitis due to house dust mite allergy in a double-blind placebo-controlled setting
Condition | Intervention | Phase |
---|---|---|
Perennial Allergic Rhinoconjunctivitis House Dust Mite Allergy |
Drug: CYT005-AllQbG10 (combination of house dust mite allergen extract with CYT003-QbG10) Drug: House dust mite allergen extract in combination with CYT003-QbG10-placebo |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment |
Official Title: | Double-Blind, Placebo-Controlled Study to Investigate Safety, Tolerability, Immunogenicity and Clinical Efficacy of a Specific Immunotherapy Combining Allergen With CYT003-QbG10 (CYT005-AllQbG10) in Adult Patients With Perennial Allergic Rhinoconjunctivitis Due to House Dust Mite Allergy |
Estimated Enrollment: | 100 |
Study Start Date: | November 2007 |
Study Completion Date: | March 2009 |
Primary Completion Date: | March 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
Arm 1: Experimental |
Drug: CYT005-AllQbG10 (combination of house dust mite allergen extract with CYT003-QbG10)
subcutaneous injections at 8 visits
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Arm 2: Placebo Comparator |
Drug: House dust mite allergen extract in combination with CYT003-QbG10-placebo
subcutaneous injections at 8 visits
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Ages Eligible for Study: | 18 Years to 65 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Responsible Party: | Cytos Biotechnology AG ( Philipp Mueller, MD, Head of Clinical Development, EVP ) |
Study ID Numbers: | CYT005-AllQbG10 04, No |
Study First Received: | December 14, 2007 |
Last Updated: | April 24, 2009 |
ClinicalTrials.gov Identifier: | NCT00574223 History of Changes |
Health Authority: | Germany: Paul-Ehrlich-Institut |
Hypersensitivity Conjunctivitis, Allergic Eye Diseases |
Hypersensitivity, Immediate Conjunctivitis Conjunctival Diseases |
Hypersensitivity Immune System Diseases Conjunctivitis, Allergic Eye Diseases |
Hypersensitivity, Immediate Conjunctivitis Conjunctival Diseases |