An Open Trial to Assess the Tolerability of AVANZ Phleum Pratense Immunotherapy

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

ALK-Abelló A/S

ClinicalTrials.gov Identifier:

NCT01454531

First received: October 13, 2011

Last updated: April 24, 2012

Last verified: April 2012

History of Changes

Tracking Information
First Received Date ^ICMJE	October 13, 2011
Last Updated Date	April 24, 2012
Start Date ^ICMJE	June 2011
Primary Completion Date	March 2012 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: October 17, 2011)	To assess the tolerability of AVANZ [ Time Frame: 6 weeks ] [ Designated as safety issue: Yes ] The frequency of patients with adverse reactions will be the study primary endpoint.
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT01454531 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: October 17, 2011)	Frequency of systemic reactions and Change in immunological parameters [ Time Frame: 6 weeks ] [ Designated as safety issue: No ] Frequency of systemic reactions, based on EAACI classification, increase in IgG4 and in IgE-blocking factor; reduction in immediate skin reactivity.
Original Secondary Outcome Measures ^ICMJE	Same as current
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	An Open Trial to Assess the Tolerability of AVANZ Phleum Pratense Immunotherapy
Official Title ^ICMJE	An Open Trial to Assess the Tolerability of AVANZ Phleum Pratense Immunotherapy
Brief Summary	The purpose of this study is to assess the tolerability of AVANZ.
Detailed Description	To assess the tolerability of the up-dosing phase of AVANZ Phleum pratense. The frequency of patients with adverse reactions will be the study primary endpoint.
Study Type ^ICMJE	Interventional
Study Phase	Phase 2 Phase 3
Study Design ^ICMJE	Endpoint Classification: Safety Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Condition ^ICMJE	Allergic Rhinoconjunctivitis
Intervention ^ICMJE	Drug: AVANZ Phleum pratense Up-dosing phase of AVANZ Phleum pratense Other Name: AVANZ
Study Arm (s)	Experimental: AVANZ Phleum pratense Intervention: Drug: AVANZ Phleum pratense
Publications *	Not Provided
* 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
Enrollment ^ICMJE	198
Completion Date	April 2012
Primary Completion Date	March 2012 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	Inclusion Criteria: History of grass pollen rhinoconjunctivitis Positive SPT to Phleum pratense Positive specific Ig E against Phleum pratense Exclusion Criteria: Uncontrolled severe asthma
Gender	Both
Ages	18 Years to 65 Years
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	Spain

Administrative Information
NCT Number ^ICMJE	NCT01454531
Other Study ID Numbers ^ICMJE	AV-G-01
Has Data Monitoring Committee	No
Responsible Party	ALK-Abelló A/S
Study Sponsor ^ICMJE	ALK-Abelló A/S
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	ALK-Abelló A/S
Verification Date	April 2012
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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