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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
History of Changes
  Purpose

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


Condition Intervention Phase
Allergy to Cat Dander
 Drug: IVN201
Drug: Placebo
 Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Evaluation of Safety, Tolerability, Immunogenicity and Efficacy of a Novel Method in Specific Immunotherapy in Cat Allergic Patients: a Placebo Controlled Trial

Further study details as provided by University of Zurich:

Primary Outcome Measures:
  • Saftety tolerability and efficacy [ Time Frame: 2009 ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 20
Study Start Date: July 2008
Study Completion Date: February 2010
Primary Completion Date: February 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Study drug
 Drug: IVN201
Intralymphativ injection of the study drug
Placebo Comparator: 2
Placebo
 Drug: Placebo

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00718679

Locations
Switzerland
Center for Clinical Research University Hospital Zurich
Zurich, Switzerland
Sponsors and Collaborators
University of Zurich
ImVision GmbH, Hannover
Investigators
Principal Investigator: Gabriela Senti, MD UniversitaetsSpital Zuerich
  More Information

No publications provided by University of Zurich

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: PD Dr. Thomas Kündig, University Hospital Zurich
ClinicalTrials.gov Identifier: NCT00718679     History of Changes
Other Study ID Numbers: IVN-CAT-001B
Study First Received: July 18, 2008
Last Updated: February 10, 2010
Health Authority: Switzerland: Swissmedic

ClinicalTrials.gov processed this record on May 16, 2013