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

October 13, 2011
April 24, 2012
June 2011
March 2012   (final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01454531 on ClinicalTrials.gov Archive Site
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.
Same as current
Not Provided
Not Provided
 
An Open Trial to Assess the Tolerability of AVANZ Phleum Pratense Immunotherapy
An Open Trial to Assess the Tolerability of AVANZ Phleum Pratense Immunotherapy

The purpose of this study is to assess the tolerability of AVANZ.

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.

Interventional
Phase 2
Phase 3
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Allergic Rhinoconjunctivitis
Drug: AVANZ Phleum pratense
Up-dosing phase of AVANZ Phleum pratense
Other Name: AVANZ
Experimental: AVANZ Phleum pratense
Intervention: Drug: AVANZ Phleum pratense
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
198
April 2012
March 2012   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • History of grass pollen rhinoconjunctivitis
  • Positive SPT to Phleum pratense
  • Positive specific Ig E against Phleum pratense

Exclusion Criteria:

  • Uncontrolled severe asthma
Both
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
Spain
 
NCT01454531
AV-G-01
No
ALK-Abelló A/S
ALK-Abelló A/S
Not Provided
Not Provided
ALK-Abelló A/S
April 2012

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