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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01918956
Other study ID # PB/0040
Secondary ID
Status Completed
Phase Phase 4
First received August 7, 2013
Last updated April 10, 2014
Start date September 2013
Est. completion date April 2014

Study information

Verified date April 2014
Source HAL Allergy
Contact n/a
Is FDA regulated No
Health authority Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Study type Interventional

Clinical Trial 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.


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Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Intervention

Biological:
PURETHAL Birch, 20.000 AUM/ml
comparison of different up-dosing regimes

Locations

Country Name City State
Poland NZOZ PROMEDICA Radlmacher i Wspólnicy Sp. J. Bialystok
Poland NZOZ Alergia Bielsko-biala
Poland NZOZ ClinicaVitae Gdansk
Poland Medica Pro Familia Sp.zo.o S.K.A Katowice
Poland NZOZ Centrum Alergologii Lódz
Poland ALERGO-MED.Specjalistyczna Przychodnia Lekarska Sp. z o.o. Tarnów
Poland Specjalistyczne Centrum Medyczne CenterMed Tarnów
Poland NZOZ CUM PROXIMUM Sp. z o.o. Wroclaw

Sponsors (2)

Lead Sponsor Collaborator
HAL Allergy Ergomed

Country where clinical trial is conducted

Poland, 

Outcome

Type Measure Description Time frame Safety issue
Primary Proportion of patients successfully reaching the maintenance dose 12 weeks Yes
Secondary Early and late local and systemic reactions 30 minutes after IMP injection and 24 hours after injection Yes
Secondary Immunological parameters (IgE, IgG) 10 weeks rush regime, 13 weeks conventional regime No
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