NCT01918956

PURETHAL Birch RUSH Study

A Prospective, Randomized, Open, Multi-centre Study to Assess Safety of PURETHAL Birch Given With a Rush Up-dosing Regimen to Patients With Allergic Rhinitis/Rhinoconjunctivitis

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 120 (estimated)
• Sponsor: HAL Allergy · Industry
• Sex: All
• Age: 12 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Allergic Rhinitis
• Allergic Rhinoconjunctivitis

Interventions

Type	Name	Description
BIOLOGICAL	PURETHAL Birch, 20.000 AUM/ml	comparison of different up-dosing regimes

Timeline

• Start date: 2013-09-01
• Primary completion: 2014-02-01
• Completion: 2014-04-01
• First posted: 2013-08-08
• Last updated: 2014-04-11

Locations

8 sites across 1 country: Poland