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This study investigates the safety of two up-dosing regimen. The safety of PURETHAL Grasses will be evaluated in a rush regimen (maximum dose reached in 3 injections during 2 weeks) compared to the conventional regimen (maximum dose reached in 6 injections during 5 weeks).
The primary parameter will be the proportion of patients who experience systemic reactions > grade I within 24 hours after injection or who need more than 2 additional injections during the up-dosing phase until the maintenance dose has been reached.
It is expected that up-dosing PURETHAL Grasses according to the rush regimen is as safe as using the conventional regimen.
Allocation: Randomized, Control: Dose Comparison, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
PURETHAL Grasses, 20.000 AUM/ml
Universitätsklinikum Bonn Klinik u. Poliklinik f. Dermatologie
Published on BioPortfolio: 2014-07-23T21:10:56-0400
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