drugset / Trial / NCT01918956
PURETHAL Birch RUSH Study
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | PURETHAL Birch, 20.000 AUM/ml | Unknown | 0.5 ml | Subcutaneous |