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

Tracking Information

First Received Date ^ICMJE

July 18, 2008

Last Updated Date

February 10, 2010

Start Date ^ICMJE

July 2008

Primary Completion Date

February 2010 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Saftety tolerability and efficacy [ Time Frame: 2009 ] [ Designated as safety issue: Yes ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00718679 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Evaluation of Safety, Tolerability, Immunogenicity and Efficacy of a Novel Method in Specific Immunotherapy in Cat Allergic Patients: a Placebo Controlled Trial

Official Title ^ICMJE

Evaluation of Safety, Tolerability, Immunogenicity and Efficacy of a Novel Method in Specific Immunotherapy in Cat Allergic Patients: a Placebo Controlled Trial

Brief Summary

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

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 1

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment

Condition ^ICMJE

Allergy to Cat Dander

Intervention ^ICMJE

Drug: IVN201
Intralymphativ injection of the study drug
Drug: Placebo

Study Arm (s)

Experimental: 1
Study drug

Intervention: Drug: IVN201
Placebo Comparator: 2
Placebo

Intervention: Drug: Placebo

Publications *

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. Epub 2012 Mar 30.

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Estimated Enrollment ^ICMJE

Completion Date

February 2010

Primary Completion Date

February 2010 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years to 65 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Switzerland

Administrative Information

NCT Number ^ICMJE

NCT00718679

Other Study ID Numbers ^ICMJE

IVN-CAT-001B

Has Data Monitoring Committee

Responsible Party

PD Dr. Thomas Kündig, University Hospital Zurich

Study Sponsor ^ICMJE

University of Zurich

Collaborators ^ICMJE

ImVision GmbH, Hannover

Investigators ^ICMJE

Principal Investigator:

Gabriela Senti, MD

UniversitaetsSpital Zuerich

Information Provided By

University of Zurich

Verification Date

February 2010

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

To Top