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PURETHAL Birch RUSH Study

NCT01918956 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2014-04-11

No results posted yet for this study

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

BIOLOGICAL

PURETHAL Birch, 20.000 AUM/ml

comparison of different up-dosing regimes

Sponsors & Collaborators

  • Ergomed

    collaborator INDUSTRY

  • HAL Allergy

    lead INDUSTRY

Principal Investigators

  • Piotr Buczyłko, Prof. · NZOZ Centrum Alergologii

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
12 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-09-30
Primary Completion
2014-02-28
Completion
2014-04-30

Countries

  • Poland

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01918956 on ClinicalTrials.gov