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| ID | Type | Description | Link |
|---|---|---|---|
| EudraCT 2008-006368-12 |
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The purpose of this study is to determine whether the oral administration of grass pollen peptides to treat allergic rhinitis is safe and well tolerated.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| gpASIT+TM | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| gpASIT+TM | Biological | oral administration of entero-coated capsules containing increasing doses of gpASIT+TM (25 to 1600µg), one dose per day for 4 days |
|
| Measure | Description | Time Frame |
|---|---|---|
| To demonstrate the clinical tolerability and safety of the treatment by looking at the absence of immediate allergic reaction. | 10 days |
| Measure | Description | Time Frame |
|---|---|---|
| vital signs clinical laboratory evaluations adverse events general physical status | 10 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital University Ghent | Ghent | 9000 | Belgium |
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