- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01454531
An Open Trial to Assess the Tolerability of AVANZ Phleum Pratense Immunotherapy
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Phase 2
- Phase 3
Contacts and Locations
Study Locations
-
-
-
Avila, Spain, 05071
- Hospital Nuestra Senora de Sonsoles
-
Badajoz, Spain, 06007
- Hospital Universitario Infanta Cristina
-
Bilbao, Spain, 48013
- Hospital de Basurto
-
Burgos, Spain, 09001
- Complejo Hospitalario de Burgos
-
Cáceres, Spain, 10004
- Hospital Nuestra Señora de La Montaña
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Cáceres, Spain, 10300
- H. Campo Arañuelo
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Madrid, Spain, 28031
- Hospital Infanta Leonor
-
Madrid, Spain, 28006
- Hospital Universitario de La Princesa
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Madrid, Spain, 28007
- Hospital Gregorio Marañón
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Madrid, Spain, 28025
- Fundación Jiménez Díaz
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Madrid, Spain, 28342
- Hospital Infanta Elena
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Madrid, Spain, 28922
- Hospital Univesitario Fundación Hospital de Alcorcón
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Malaga, Spain, 29009
- Hospital Carlos Haya
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Palencia, Spain, 34005
- Hospital Río Carrión
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Puertollano, Spain, 13500
- Hospital Santa Bárbara
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Salamanca, Spain, 37007
- Hospital Universitario de Salamanca
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Santander, Spain, 39008
- Hospital Univeritario Marques de Valdeilla
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Valencia, Spain, 46026
- Hospital Universitari Politecnic La Fe
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Vitoria, Spain, 01004
- Hospital Santiago Apostol
-
Zamora, Spain, 49022
- Hospital Virgen de la Concha
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- History of grass pollen rhinoconjunctivitis
- Positive SPT to Phleum pratense
- Positive specific IgE against Phleum pratense
Exclusion Criteria:
- Uncontrolled severe asthma
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: AVANZ Phleum pratense
AVANZ Phleum pratense up-dosing phase (300, 600, 3000, 6000 and 15,000 SQ+) + one 15,000 SQ+ maintenance injection
|
AVANZ Phleum pratense up-dosing phase (300, 600, 3000, 6000 and 15,000 SQ+) + one 15,000 SQ+ maintenance injection
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Frequency of Subjects With Adverse Drug Reactions
Time Frame: 6 weeks
|
Frequency of patients with adverse reactions, local or systemic
|
6 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Frequency of Subjects With Systemic Reactions
Time Frame: 6 weeks
|
Frequency of patients with systemic reactions, based on EAACI classification: Grade I (mild systemic reaction) to IV (anaphylactic shock)
|
6 weeks
|
Frequency of Subjects With Local Adverse Reaction
Time Frame: 6 weeks
|
Frequency of patients with local adverse reactions
|
6 weeks
|
Change in Phleum Pratense Specific IgE-blocking Factor
Time Frame: baseline (visit 1) and at 6 weeks (visit 6)
|
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 |
baseline (visit 1) and at 6 weeks (visit 6)
|
Change in Phleum Pratense Specific IgG4
Time Frame: baseline (visit 1) and at 6 weeks (visit 6)
|
baseline (visit 1) and at 6 weeks (visit 6)
|
|
Change in Immediate Cutaneous Response to Phleum Pratense
Time Frame: baseline (visit 1) and at 6 weeks (visit 6)
|
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
|
baseline (visit 1) and at 6 weeks (visit 6)
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: JOAQUIN SASTRE, MD, PhD, Fundación Jiménez Díaz
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- AV-G-01
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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