- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00718679
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)
February 10, 2010 updated by: University of Zurich
This study is placebo controlled, double blind, randomised, two arm dose escalation of a new product for specific immunotherapy in cat allergic patients
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
20
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Zurich, Switzerland
- Center for Clinical Research University Hospital Zurich
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: 2
Placebo
|
|
Experimental: 1
Study drug
|
Intralymphativ injection of the study drug
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Saftety tolerability and efficacy
Time Frame: 2009
|
2009
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Gabriela Senti, MD, Universitaetsspital Zuerich
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Freiberger SN, Zehnder M, Gafvelin G, Gronlund H, Kundig TM, Johansen P. IgG4 but no IgG1 antibody production after intralymphatic immunotherapy with recombinant MAT-Feld1 in human. Allergy. 2016 Sep;71(9):1366-70. doi: 10.1111/all.12946. Epub 2016 Jun 17.
- Senti G, Crameri R, Kuster D, Johansen P, Martinez-Gomez JM, Graf N, Steiner M, Hothorn LA, Gronlund H, Tivig C, Zaleska A, Soyer O, van Hage M, Akdis CA, Akdis M, Rose H, Kundig 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
July 1, 2008
Primary Completion (Actual)
February 1, 2010
Study Completion (Actual)
February 1, 2010
Study Registration Dates
First Submitted
July 18, 2008
First Submitted That Met QC Criteria
July 18, 2008
First Posted (Estimate)
July 21, 2008
Study Record Updates
Last Update Posted (Estimate)
February 11, 2010
Last Update Submitted That Met QC Criteria
February 10, 2010
Last Verified
February 1, 2010
More Information
Terms related to this study
Other Study ID Numbers
- IVN-CAT-001B
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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