NCT00266526

Brief Summary

Specific immunotherapy with recombinant birch pollen allergen rBet v1-FV

Trial Health

87
On Track

Trial Health Score

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

Timeline
Completed

Started Jul 2003

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

July 1, 2003

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2004

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2005

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

December 16, 2005

Completed
3 days until next milestone

First Posted

Study publicly available on registry

December 19, 2005

Completed
Last Updated

March 4, 2013

Status Verified

March 1, 2013

Enrollment Period

1 year

First QC Date

December 16, 2005

Last Update Submit

March 1, 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 RAST result to birch pollen
  • Positive Skin Prick Test reaction to birch pollen
  • positive nasal provocation test result to birch pollen extract

You may not qualify if:

  • serious chronic diseases
  • other relevant seasonal allergies

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Allergopharma GmbH & Co. KG

Reinbek, 21465, Germany

Location

Related Publications (1)

  • Klimek L, Bachert C, Lukat KF, Pfaar O, Meyer H, Narkus A. Allergy immunotherapy with a hypoallergenic recombinant birch pollen allergen rBet v 1-FV in a randomized controlled trial. Clin Transl Allergy. 2015 Aug 3;5:28. doi: 10.1186/s13601-015-0071-x. eCollection 2015.

    PMID: 26328056DERIVED

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 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 16, 2005

First Posted

December 19, 2005

Study Start

July 1, 2003

Primary Completion

July 1, 2004

Study Completion

July 1, 2005

Last Updated

March 4, 2013

Record last verified: 2013-03

Locations

DE(1)