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: February 23, 2015
Last verified: February 2015

October 13, 2011
February 23, 2015
June 2011
March 2012   (final data collection date for primary outcome measure)
Frequency of Subjects With Adverse Drug Reactions [ Time Frame: 6 weeks ] [ Designated as safety issue: Yes ]
Frequency of patients with adverse reactions, local or systemic
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.
Complete list of historical versions of study NCT01454531 on ClinicalTrials.gov Archive Site
  • Frequency of Subjects With Systemic Reactions [ Time Frame: 6 weeks ] [ Designated as safety issue: Yes ]
    Frequency of patients with systemic reactions, based on EAACI classification: Grade I (mild systemic reaction) to IV (anaphylactic shock)
  • Frequency of Subjects With Local Adverse Reaction [ Time Frame: 6 weeks ] [ Designated as safety issue: Yes ]
    Frequency of patients with local adverse reactions
  • Change in Phleum Pratense Specific IgE-blocking Factor [ Time Frame: baseline (visit 1) and at 6 weeks (visit 6) ] [ Designated as safety issue: No ]

    IgE-blocking factor measures the amount of IgE bound to the allergen in the presence of allergen-competing factors present in the serum of a subject treated with allergen immunotherapy. The test is based in a double IgE measurement, an ordinary assay and an assay in the presence of competing components and takes the form of:

    IgE blocking factor = 1 - (Competitive IgE/Ordinary IgE). Theoretical limits are from 0 (no IgE blocked) to 1 (all IgE blocked) and, being a ratio, is a dimensionless measure

  • Change in Phleum Pratense Specific IgG4 [ Time Frame: baseline (visit 1) and at 6 weeks (visit 6) ] [ Designated as safety issue: No ]
  • Change in Immediate Cutaneous Response to Phleum Pratense [ Time Frame: baseline (visit 1) and at 6 weeks (visit 6) ] [ Designated as safety issue: No ]
    Wheal size provoked after prick test with 4, 20 and 100 µg/ml Phl p 5 allergen extracts analysed by Parallel Line Assay. Cutaneous Tolerance Index (CTI) is the factor it is necessary to multiply the extract concentration by after SCIT (V6) to obtain the same response in terms of wheal area as at baseline (V1). CTI, being an index, is a dimensionless measure. A CTI of 1 indicates no change in skin sensitivity while if higher than 1 a decrease in skin sensitivity (it would be needed a more concentrated allergen extract at V6 to elicit the same skin response as at V1
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.
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
AVANZ Phleum pratense up-dosing phase (300, 600, 3000, 6000 and 15,000 SQ+) + one 15,000 SQ+ maintenance injection
Experimental: AVANZ Phleum pratense
AVANZ Phleum pratense up-dosing phase (300, 600, 3000, 6000 and 15,000 SQ+) + one 15,000 SQ+ maintenance injection
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
199
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 IgE 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
Principal Investigator: JOAQUIN SASTRE, MD, PhD FUNDACIÓN JIMÉNEZ DIAZ
ALK-Abelló A/S
February 2015

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