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Dose Finding Study With CYT003-QbG10 in Patients With House Dust Mite Allergy

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00800332
First Posted: December 2, 2008
Last Update Posted: November 15, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Cytos Biotechnology AG
  Purpose
The purpose of the study is to test whether vaccinations with CYT003-QbG10 can improve allergy symptoms in patients with house dust mite allergy. The active treatment will be compared against placebo.

Condition Intervention Phase
Rhinoconjunctivitis Allergies Drug: CYT003-QbG10 Drug: Placebo Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Double-blind, Placebo-controlled Dose-finding Study With CYT003-QbG10 in Adult Patients With Rhinoconjunctivitis Due to House Dust Mite Allergy

Resource links provided by NLM:


Further study details as provided by Cytos Biotechnology AG:

Primary Outcome Measures:
  • Rhinoconjunctivitis symptom and medication scores [ Time Frame: Pre- / Post-Treatment ]

Estimated Enrollment: 300
Study Start Date: November 2008
Study Completion Date: November 2010
Primary Completion Date: April 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: CYT003-QbG10
subcutaneous injection
Experimental: 2 Drug: CYT003-QbG10
subcutaneous injection
Placebo Comparator: 3 Drug: Placebo
subcutaneous injection

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Perennial allergic rhinoconjunctivitis due to clinically relevant allergy towards house dust mite allergens
  • Further criteria as defined in the study protocol

Exclusion Criteria:

  • Clinically manifested seasonal allergy/-ies which is/are expected to interfere with the patient's study treatment schedule and/or assessments
  • Clinically relevant perennial allergy/-ies other than house dust mites allergy
  • Contraindication to any study test or procedure
  • Further criteria as defined in the study protocol
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00800332


Locations
Estonia
Cytos Investigator Sites
Paide, Tartu, Tallin, Rakvere, Estonia
Germany
Cytos Investigator Sites
Fulda, Dresden, Ulm, Rodgau, Kassel, Eisenach, Germany
Cytos Investigator Sites
Wiesbaden, Frankfurt/M, Leipzig, Jena, Hamburg, Dulmen, Germany
Greece
Cytos Investigator Sites
N. Faliro, Hiraklion, Athens, Greece
Latvia
Cytos Investigator Sites
Riga, Rezekne, Latvia
Lithuania
Cytos Investigator Sites
Vilnius, Kaunas, Klaipeda, Lithuania
Romania
Cytos Investigator Sites
Galati, Cluj Napoca, Bahia Mare, Brasov, Piesti, Romania
Cytos Investigator Sites
Targu Mures, Bukarest, Craiova, Iasi, Romania
Sponsors and Collaborators
Cytos Biotechnology AG
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Clinical Development, Cytos Biotechnology
ClinicalTrials.gov Identifier: NCT00800332     History of Changes
Other Study ID Numbers: CYT003-QbG10 09
First Submitted: December 1, 2008
First Posted: December 2, 2008
Last Update Posted: November 15, 2010
Last Verified: November 2010

Keywords provided by Cytos Biotechnology AG:
Rhinoconjunctivitis due to house dust mite allergy

Additional relevant MeSH terms:
Hypersensitivity
Conjunctivitis
Immune System Diseases
Conjunctival Diseases
Eye Diseases