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
  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 August 26, 2014