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Evaluation of Safety, Tolerability, Immunogenicity and Efficacy of a Novel Method in Specific Immunotherapy in Cat Allergic Patients: a Placebo Controlled Trial (IVN-CAT-001B)

This study has been completed.
Sponsor:
Collaborator:
ImVision GmbH, Hannover
Information provided by:
University of Zurich
ClinicalTrials.gov Identifier:
NCT00718679
First received: July 18, 2008
Last updated: February 10, 2010
Last verified: February 2010

July 18, 2008
February 10, 2010
July 2008
February 2010   (final data collection date for primary outcome measure)
Saftety tolerability and efficacy [ Time Frame: 2009 ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00718679 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Evaluation of Safety, Tolerability, Immunogenicity and Efficacy of a Novel Method in Specific Immunotherapy in Cat Allergic Patients: a Placebo Controlled Trial
Evaluation of Safety, Tolerability, Immunogenicity and Efficacy of a Novel Method in Specific Immunotherapy in Cat Allergic Patients: a Placebo Controlled Trial

This study is placebo controlled, double blind, randomised, two arm dose escalation of a new product for specific immunotherapy in cat allergic patients

Not Provided
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Allergy to Cat Dander
  • Drug: IVN201
    Intralymphativ injection of the study drug
  • Drug: Placebo
  • Experimental: 1
    Study drug
    Intervention: Drug: IVN201
  • Placebo Comparator: 2
    Placebo
    Intervention: Drug: Placebo
Senti G, Crameri R, Kuster D, Johansen P, Martinez-Gomez JM, Graf N, Steiner M, Hothorn LA, Grönlund H, Tivig C, Zaleska A, Soyer O, van Hage M, Akdis CA, Akdis M, Rose H, Kündig TM. Intralymphatic immunotherapy for cat allergy induces tolerance after only 3 injections. J Allergy Clin Immunol. 2012 May;129(5):1290-6. doi: 10.1016/j.jaci.2012.02.026. Epub 2012 Mar 30.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
20
February 2010
February 2010   (final data collection date for primary outcome measure)

Inclusion criteria:

  • History and subjective symptoms of cat dander allergy including cat specific allergic rhinitis
  • Age 18 to 65 years
  • Positive reaction to at least one concentration of cat dander allergen in skin prick test, intradermal provocation test and nasal provocation test

Exclusion criteria:

  • Chronic infectious disease
  • Acute infections
  • Episode of non-allergic rhinitis within the last 4 weeks
  • Use of allergen known to predict anaphylactic reactions
  • Treatment with any other investigational drug within 3 months before trial entry
  • Vaccination within the last week
  • Nasal surgery within the last 8 weeks
  • Progressive fatal disease
  • Drug or alcohol abuse within the last 5 years
  • Cat ownership
  • A history of significant cardiac insufficiency (NYHA stage III-IV)
  • Coexisting severe disease, e.g. cardiovascular diseases
  • Acute or history of obstructive respiratory insufficiency ( FEV1 <70%)
  • Hepatic insufficiency
  • Relevant anaemia (as judged by investigator)
  • Blood donation within the last 30 days or intended blood donation (during the study or 30 days after participation)
  • Pregnancy or breast feeding
  • Sexually active woman of childbearing potential not actively practicing birth control by using a medically accepted device or therapy
  • Lack of compliance or other sililar reason, that the investigator believes, precludes satisfactory participation in the study
  • Systemic glucocorticoid therapy
  • Allergic asthma and chronic medication with steroids at doses exceeding 200ug/day Treatment with ATII antagonists, B-blocker, ACE inhibitors
Both
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
Switzerland
 
NCT00718679
IVN-CAT-001B
No
PD Dr. Thomas Kündig, University Hospital Zurich
University of Zurich
ImVision GmbH, Hannover
Principal Investigator: Gabriela Senti, MD UniversitaetsSpital Zuerich
University of Zurich
February 2010

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