Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00309062
Other study ID # Al0103rB
Secondary ID
Status Completed
Phase Phase 3
First received March 30, 2006
Last updated March 8, 2013
Start date December 2003
Est. completion date June 2009

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

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


Recruitment information / eligibility

Status Completed
Enrollment 0
Est. completion date June 2009
Est. primary completion date June 2006
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 60 Years
Eligibility Inclusion Criteria:

- Positive Skin Prick Test reaction to birch pollen

- Positive RAST result to birch pollen

- Positive Provocation Test result to birch pollen

Exclusion Criteria:

- Serious chronic diseases

- Other perennial allergies

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, 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
Completed NCT06037148 - Study to Evaluate Safety, Tolerability and Explorative Efficacy of DM-101PX in Birch Pollen Allergic Participants Phase 1
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 NCT00266526 - Specific Immunotherapy With Recombinant Birch Pollen Allergen rBet v1-FV Phase 2
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 NCT02074930 - Comparison of the Influence of Different Skin Conditions on the Allergic Skin Reactivity to Epicutanous Allergen Exposure N/A
Completed NCT04266028 - Study to Evaluate Safety and Tolerability of sc Immunotherapy With DM-101 in Adults With Birch Pollen Allergy Phase 1
Completed NCT01675791 - A Dose-response Evaluation of ALK (the Sponsor) Tree Allergy Immunotherapy Tablet Phase 2