NCT00309062

Brief Summary

Safety and efficacy of recombinant birch pollen allergen in the treatment of allergic rhinoconjunctivitis

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Timeline
Completed

Started Dec 2003

Longer than P75 for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2003

Completed
2.3 years until next milestone

First Submitted

Initial submission to the registry

March 30, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 31, 2006

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2006

Completed
3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2009

Completed
Last Updated

March 11, 2013

Status Verified

March 1, 2013

Enrollment Period

2.5 years

First QC Date

March 30, 2006

Last Update Submit

March 8, 2013

Conditions

Birch Pollen Allergy

Keywords

AllergyBirch pollenRecombinant

Interventions

Recombinant birch pollenBIOLOGICAL

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Positive Skin Prick Test reaction to birch pollen
  • Positive RAST result to birch pollen
  • Positive Provocation Test result to birch pollen

You may not qualify if:

  • Serious chronic diseases
  • Other perennial allergies

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Allergopharma GmbH & Co. KG

Reinbek, 21465, Germany

Location

Related Links

MeSH Terms

Conditions

Hypersensitivity

Condition Hierarchy (Ancestors)

Immune System Diseases

Study Officials

  • Annemie Narkus, M D

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 30, 2006

First Posted

March 31, 2006

Study Start

December 1, 2003

Primary Completion

June 1, 2006

Study Completion

June 1, 2009

Last Updated

March 11, 2013

Record last verified: 2013-03

Locations

DE(1)