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Depigoid Birch 5000 Longterm Study in Adults and Adolescents

NCT01694836 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 634

Last updated 2019-01-16

No results posted yet for this study

Summary

Specific immunotherapy for IgE mediated sensitization to birch pollen. Long-term study to assess safety and efficacy of Depigoid(R)Birch 5000 - a modified pollen extract of Betula alba (Birch) - versus placebo.

Conditions

  • Allergic Rhinitis/Rhinoconjunctivitis +-Intermittent Asthma
  • Sensitization Against Betula Alba (Birch) Pollen

Interventions

BIOLOGICAL

s.c. injection

3 years of therapy followed by 2 years (seasons) of treatment-free observational period

Sponsors & Collaborators

  • Leti Pharma GmbH

    lead INDUSTRY

Principal Investigators

  • Natalja Novak, Prof. Dr. · Klinik für Dermatologie und Allergologie der Universität Bonn

  • Angelika Sager, Dr. med. · Leti Pharma GmbH

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
12 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-09-17
Primary Completion
2018-07-30
Completion
2018-07-30

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 NCT01694836 on ClinicalTrials.gov