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NCT00266526 Clinical Trial

Specific Immunotherapy With Recombinant Birch Pollen Allergen rBet v1-FV

Birch Pollen Allergy Clinical Trial

Official title:
A Bicentre Open Label Randomised Pilot Study for Proof of Safety and Efficacy of Immunotherapy With an Aluminium Hydroxide-adsorbed Recombinant Hypoallergenic Derivative of the Major Birch Pollen Allergen Bet v 1-FV Versus a Depot Extract of Natural Birch Allergen

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00266526
Other study ID # Al0303rB
Secondary ID
Status Completed
Phase Phase 2
First received December 16, 2005
Last updated March 1, 2013
Start date July 2003
Est. completion date July 2005

Study information
Verified date March 2013
Source Allergopharma GmbH & Co. KG
Contact n/a
Is FDA regulated No
Health authority Germany: Paul-Ehrlich-Institut
Study type Interventional

Clinical Trial Summary

Specific immunotherapy with recombinant birch pollen allergen rBet v1-FV

Recruitment information / eligibility
Status Completed
Enrollment 0
Est. completion date July 2005
Est. primary completion date July 2004
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 60 Years
Eligibility 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:

- serious chronic diseases

- other relevant seasonal allergies

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Biological:
• Recombinant birch pollen

Locations
Country Name City State
Germany Allergopharma GmbH & Co. KG Reinbek

Sponsors (1)
Lead Sponsor Collaborator
Allergopharma GmbH & Co. KG

Country where clinical trial is conducted

Germany, 

See also
  Status Clinical Trial Phase
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Completed NCT04912076 - S.C. Immunotherapy With BM41 in Patients With Allergic Rhino-conjunctivitis Caused by Birch Pollen Phase 1
Recruiting NCT05346718 - Threshold Concentrations for Ragweed and Birch Pollen in Seasonal Allergic Rhinitis N/A
Completed NCT01137357 - Probiotics for Reduction Of Markers In Subjects With Allergy N/A
Active, not recruiting NCT05668390 - Safety and Efficacy of STALORAL® Birch 300 IR in a Paediatric Population With Birch Pollen-induced ARC w/o Asthma Phase 3
Not yet recruiting NCT02146300 - Effect of the Nasal Provocation on the Breathing Style N/A
Completed NCT01449786 - Sublingual Immunotherapy of Birch Pollen Associated Apple Allergy Phase 2
Completed NCT03969849 - Study to Assess the Safety, Tolerability, Pharmacokinetic, and Pharmacodynamic Effects of a Single Dose of REGN5713-5714-5715 in Healthy Adult Participants Phase 1
Completed NCT04435678 - Diagnostic Accuracy of the MADx Multi Array Xplorer (MAX 45k) Automated Laboratory System and the MADx Allergy Explorer Version 2 (ALEX²) - IgE Multiplex Test for the Diagnosis of Pre-defined Groups of Specific High-priority Allergens N/A
Completed NCT01628484 - Physiological Study to Determine the Allergic Skin Activity After Different Skin Preparation Phase 1
Completed NCT00932607 - SUBLIVAC® Birch PROBE Study Phase 2
Completed NCT02074930 - Comparison of the Influence of Different Skin Conditions on the Allergic Skin Reactivity to Epicutanous Allergen Exposure N/A
Completed NCT02143583 - Follow-up of Study AN004T to Assess the Persistence of AllerT Efficacy During the 2nd to 4th Season After Treatment Phase 2
Completed NCT04266028 - Study to Evaluate Safety and Tolerability of sc Immunotherapy With DM-101 in Adults With Birch Pollen Allergy Phase 1
Completed NCT00309062 - Safety and Efficacy of Recombinant Birch Pollen Allergen in the Treatment of Allergic Rhinoconjunctivitis Phase 3
Completed NCT01675791 - A Dose-response Evaluation of ALK (the Sponsor) Tree Allergy Immunotherapy Tablet Phase 2

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