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CompletedNCT00266526Updated Mar 4, 2013

Specific Immunotherapy With Recombinant Birch Pollen Allergen rBet v1-FV

A Phase 2 interventional study of Recombinant birch pollen in Birch Pollen Allergy, sponsored by Allergopharma GmbH & Co. KG. Completed at 1 site in Germany. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2013-03-04.

Sponsored by Allergopharma GmbH & Co. KG · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Allocation
Randomized
Ages
18 Years to 60 Years
Sex
All
01

Study summary

Specific immunotherapy with recombinant birch pollen allergen rBet v1-FV

02

Conditions studied

  • Birch Pollen Allergy

Keywords

  • Allergy
  • Birch pollen
  • Recombinant
03

In context

Rhinitis, Allergic, Seasonal

392 studies on the registry are indexed under Rhinitis, Allergic, Seasonal; 25 are open to participants now.

Browse Rhinitis, Allergic, Seasonal studies →

Lead sponsor

Allergopharma GmbH & Co. KG is the lead sponsor of 23 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • serious chronic diseases
  • other relevant seasonal allergies
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)

Interventions

  • BiologicalRecombinant birch pollen
06

Study locations

1 site
  • Allergopharma GmbH & Co. KG
    Reinbek, 21465, Germany
07

References and documents

Publications

  • 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. PubMed 26328056 ↗
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 4, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00266526
Lead sponsor
Allergopharma GmbH & Co. KG
Responsible party
Sponsor
First posted
Dec 19, 2005
Start date
Jul 2003
Primary completion
Jul 2004
Completion
Jul 2005
Last update
Mar 4, 2013

Study contacts

Annemie Narkus, M.D.
principal investigator
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2013. You cannot join it, but the record below documents what was studied.

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