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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AVANZ Phleum pratense | Experimental | AVANZ Phleum pratense up-dosing phase (300, 600, 3000, 6000 and 15,000 SQ+) + one 15,000 SQ+ maintenance injection |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AVANZ Phleum pratense | Drug | AVANZ Phleum pratense up-dosing phase (300, 600, 3000, 6000 and 15,000 SQ+) + one 15,000 SQ+ maintenance injection |
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| Measure | Description | Time Frame |
|---|---|---|
| Frequency of Subjects With Adverse Drug Reactions | Frequency of patients with adverse reactions, local or systemic | 6 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Frequency of Subjects With Systemic Reactions | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| JOAQUIN SASTRE, MD, PhD | FUNDACIÓN JIMÉNEZ DIAZ | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital de Basurto | Bilbao | Bilbao | 48013 | Spain | ||
| Fundación Jiménez Diaz |
199 subjects were recruited and 3 resulted screening failures so 196 subjects started the trial. Four subjects discontinued before treatment so 192 subjects were treated. The reason for discontinuation for these 4 subjects was withdrawal of consent ("Withdrawal by subject", included in Reasons Not Completed)
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| ID | Title | Description |
|---|---|---|
| FG000 | AVANZ Phleum Pratense | AVANZ Phleum pratense AVANZ Phleum pratense: Up-dosing phase of AVANZ Phleum pratense |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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Frequency of patients with local adverse reactions
| 6 weeks |
| Change in Phleum Pratense Specific IgE-blocking Factor | 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 | baseline (visit 1) and at 6 weeks (visit 6) |
| Change in Immediate Cutaneous Response to Phleum Pratense | 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) |
| Madrid |
| Madrid |
| 28025 |
| Spain |
| Hospital Infanta Elena | Madrid | Madrid | 28342 | Spain |
| Hospital Universitari Politecnic La Fe | Valencia | Valencia | 46026 | Spain |
| Hospital Nuestra Señora de Sonsoles | Ávila | 05071 | Spain |
| Hospital Universitario Infanta Cristina | Badajoz | 06007 | Spain |
| Complejo Hospitalario de Burgos | Burgos | 09001 | Spain |
| Hospital Nuestra Señora de La Montaña | Cáceres | 10004 | Spain |
| H. Campo Arañuelo | Cáceres | 10300 | Spain |
| Hospital Universitario de La Princesa | Madrid | 28006 | Spain |
| Hospital Gregorio Marañón | Madrid | 28007 | Spain |
| Hospital Infanta Leonor | Madrid | 28031 | Spain |
| Hospital Univesitario Fundación Hospital de Alcorcón | Madrid | 28922 | Spain |
| Hospital Carlos Haya | Málaga | 29009 | Spain |
| Hospital Rio Carrion | Palencia | 34005 | Spain |
| Hospital Santa Bárbara | Puertollano | 13500 | Spain |
| Hospital Universitario de Salamanca | Salamanca | 37007 | Spain |
| Hospital Univeritario Marques de Valdeilla | Santander | 39008 | Spain |
| Hospital Santiago Apostol | Vitoria-Gasteiz | 01004 | Spain |
| Hospital Virgen de La Concha | Zamora | 49022 | Spain |
| Subjects Treated |
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| COMPLETED |
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| NOT COMPLETED |
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Subjects treated
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| ID | Title | Description |
|---|---|---|
| BG000 | AVANZ Phleum Pratense | AVANZ Phleum pratense AVANZ Phleum pratense: Up-dosing phase of AVANZ Phleum pratense |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Frequency of Subjects With Adverse Drug Reactions | Frequency of patients with adverse reactions, local or systemic | Subjects treated | Posted | Number | participants | 6 weeks |
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| Secondary | Frequency of Subjects With Systemic Reactions | Frequency of patients with systemic reactions, based on EAACI classification: Grade I (mild systemic reaction) to IV (anaphylactic shock) | Posted | Number | participants | 6 weeks |
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| Secondary | Frequency of Subjects With Local Adverse Reaction | Frequency of patients with local adverse reactions | Posted | Number | participants | 6 weeks |
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| Secondary | Change in Phleum Pratense Specific IgE-blocking Factor | 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 | Posted | Mean | Standard Deviation | arbitrary units | baseline (visit 1) and at 6 weeks (visit 6) |
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| Secondary | Change in Phleum Pratense Specific IgG4 | Number of subject with valid data in visit 1 and visit 6 | Posted | Mean | Standard Deviation | mgA/l | baseline (visit 1) and at 6 weeks (visit 6) |
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| Secondary | Change in Immediate Cutaneous Response to Phleum Pratense | 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 | Participants in which results of the Parallel Line Assay are valid | Posted | Mean | 95% Confidence Interval | CTI, Cutaneous Tolerance Index | baseline (visit 1) and at 6 weeks (visit 6) |
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6 weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | AVANZ Phleum Pratense | AVANZ Phleum pratense AVANZ Phleum pratense: Up-dosing phase of AVANZ Phleum pratense | 3 | 192 | 109 | 192 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Generalised urticaria | Skin and subcutaneous tissue disorders | MedDRA 14.0 | Systematic Assessment |
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| Anaphylactic reaction | Immune system disorders | MedDRA 14.0 | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hypersensitivity | Immune system disorders | MedDRA 14.0 | Systematic Assessment |
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| Rhinitis allergic | Respiratory, thoracic and mediastinal disorders | MedDRA 14.0 | Systematic Assessment |
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| Urticaria | Skin and subcutaneous tissue disorders | MedDRA 14.0 | Systematic Assessment |
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| Local reactions | General disorders | MedDRA 14.0 | Systematic Assessment | Includes injection site pain, erythema, pruritus and/or swelling of any intensity or size |
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All presentations/publications must be approved by ALK prior to public presentation/submission. Investigators agree not to present data gathered from one trial centre or a small group of trial centres before the full publication unless formally agreed by all other investigators and ALK. ALK has the right to review and comment any manuscript within 30 days of receipt, but cannot prevent publications of findings.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| ALICIA MARIN | ALK-ABELLÓ | +34 913276127 | amaes@alk.net |
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