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PURETHAL Grasses Rush Study

NCT01059266 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 150

Last updated 2012-02-10

No results posted yet for this study

Summary

This study investigates the safety of two up-dosing regimen. The safety of PURETHAL Grasses will be evaluated in a rush regimen (maximum dose reached in 3 injections during 2 weeks) compared to the conventional regimen (maximum dose reached in 6 injections during 5 weeks).

The primary parameter will be the proportion of patients who experience systemic reactions \> grade I within 24 hours after injection or who need more than 2 additional injections during the up-dosing phase until the maintenance dose has been reached.

It is expected that up-dosing PURETHAL Grasses according to the rush regimen is as safe as using the conventional regimen.

Conditions

  • Allergic Rhinitis
  • Allergic Rhinoconjunctivitis

Interventions

DRUG

PURETHAL Grasses, 20.000 AUM/ml

subcutaneous injections of increasing doses according to the described regimen

Sponsors & Collaborators

  • HAL Allergy

    lead INDUSTRY

Principal Investigators

  • Oliver Pfaar, MD · Zentrum für Rhinologie & Allergologie, An den Quellen 10, D - 65183 Wiesbaden

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-02-28
Primary Completion
2010-09-30
Completion
2010-09-30

Countries

  • Germany

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 NCT01059266 on ClinicalTrials.gov