drugset / Trial / NCT01059266

PURETHAL Grasses Rush Study

NCT01059266 ↗

Phase 4 Completed 150 enrolled HAL Allergy
RandomizedParallel-groupOpen-labelTreatment

Summary

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.

Timeline

Start
2010-02
Primary completion
2010-09
Completion
2010-09

Drugs

EvaluationDrugModalityDoseRoute
Subject PURETHAL Grasses, 20.000 AUM/ml Unknown 0.5 ml Subcutaneous

Indications