drugset / Trial / NCT01918956

PURETHAL Birch RUSH Study

NCT01918956 ↗

Phase 4 Completed 120 enrolled HAL Allergy Ergomed GmbH · collab
RandomizedParallel-groupOpen-labelTreatment

Summary

This study investigates the safety of two up-dosing regimen. The safety of PURETHAL Birch will be evaluated in a rush regimen (maximum dose reached in 3 injections during 3 weeks) compared to the conventional regimen (maximum dose reached in 6 injections during 6 weeks). The primary endpoint of the sudy is the comparison of the proportions of the patients who have successfully reached the maintenance dose between the two treatment regimes. A similar previous study with PURETHAL Grasses has shown that the rush up-dosing scheme is as safe as the conventional up-dosing regime. Therefore it is expected that up-dosing with PURETHAL Birch according to the rush regimen is as safe as using the conventional regimen.

Timeline

Start
2013-09
Primary completion
2014-02
Completion
2014-04

Drugs

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

Indications