NCT00554983CompletedPhase 3
A Multicentre Randomised Placebo-controlled Double-blind Pivotal Clinical Trial for the Evaluation of Safety and Efficacy of Specific Immunotherapy With an Aluminium Hydroxide-adsorbed Recombinant Hypoallergenic Derivative of the Major Birch Pollen Allergen, rBet v 1-FV
Allergopharma GmbH & Co. KG2 sites in 1 country255 target enrollmentStarted: September 2007Last updated:
Conditions
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Allergopharma GmbH & Co. KG
- Enrollment
- 255
- Locations
- 2
- Primary Endpoint
- Symptom-Medication-Score
Study Overview
Brief Summary
Efficacy and Safety from a recombinant folding variant of Bet v 1
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 18 Years to 60 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Allergic rhinoconjunctivitis attributable to birch pollen
- •Positive SPT
- •Positive EAST
- •Positive specific provocation test
Exclusion Criteria
- •Serious chronic diseases
- •Other perennial allergies
Outcomes
Primary Outcomes
Symptom-Medication-Score
Time Frame: during pollen season
Secondary Outcomes
No secondary outcomes reported
Investigators
Study Sites (2)
Loading locations...
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