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Efficacy and Safety From a Recombinant Folding Variant of Bet v 1

NCT00554983 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 255

Last updated 2013-11-08

No results posted yet for this study

Summary

Efficacy and Safety from a recombinant folding variant of Bet v 1

Conditions

  • Allergy

Interventions

BIOLOGICAL

recombinant birch pollen allergen

subcutaneous injections (s.c.). Dosage escalation phase from 0.75 to 80 microgram maintenance dose s.c. injections of 80 microgram

BIOLOGICAL

placebo

subcutaneous injections (s.c.). Dosage escalation phase from 0.75 to 80 microgram maintenance dose s.c. injections of 80 microgram

Sponsors & Collaborators

  • Allergopharma GmbH & Co. KG

    lead INDUSTRY

Principal Investigators

  • Ludger Klimek, Professor

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-09-30
Primary Completion
2010-06-30
Completion
2012-05-31

Countries

  • Germany

Study Locations

More Related Trials

Entities

Drugs

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 NCT00554983 on ClinicalTrials.gov