Birch Pollen AllergyPhase 3NCT00309062
Safety and Efficacy of Recombinant Birch Pollen Allergen in the Treatment of Allergic Rhinoconjunctivitis
A Phase 3 study testing Recombinant birch pollen in people with Birch Pollen Allergy, run by Allergopharma GmbH & Co. KG at 1 site in Germany.
Trial summary
Safety and efficacy of recombinant birch pollen allergen in the treatment of allergic rhinoconjunctivitis Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Birch Pollen Allergy
- What is being tested?
- Recombinant birch pollen
- How many people
- Not given
- Where
- 1 siteGermany
- Study dates
- Dec 2003to Jun 2009
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Positive Skin Prick Test reaction to birch pollen
- Positive RAST result to birch pollen
- Positive Provocation Test result to birch pollen
Who cannot join
- Serious chronic diseases
- Other perennial allergies
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Multicentre Randomised Placebo-controlled Double-blind Clinical Trial for Evaluation of Safety and Efficacy of Immunotherapy With an Aluminium Hydroxide-adsorbed Recombinant Hypoallergenic Derivative of the Major Birch Pollen Allergen, Bet v 1
Safety and efficacy of recombinant birch pollen allergen in the treatment of allergic rhinoconjunctivitis
- Conditions
- Birch Pollen Allergy
- Being tested
- Recombinant birch pollen
- Keywords
- Allergy, Birch pollen, Recombinant
- Medical subject headings
- Hypersensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Recombinant birch pollenBiological
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2006 (estimated)
- Study startDec 2003
- Primary completionJun 2006
- Study completionJun 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Birch Pollen AllergyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Sponsor and investigators
- Lead sponsor
- Allergopharma GmbH & Co. KG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Annemie Narkus, M D, Principal investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00309062
- Sponsor's protocol ID
- Al0103rB
- Status last verified
- Mar 2013
- First submitted
- 30 Mar 2006
- Last updated
- 11 Mar 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicentre Randomised Placebo-controlled Double-blind Clinical Trial for Evaluation of Safety and Efficacy of Immunotherapy With an Aluminium Hydroxide-adsorbed Recombinant Hypoallergenic Derivative of the Major Birch Pollen Allergen, Bet v 1
- ClinicalTrials.gov ID
- NCT00309062
- Acronym / sponsor ID
- Al0103rB
- Conditions
- Birch Pollen Allergy
- Keywords
- Allergy, Birch pollen, Recombinant
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- Allergopharma GmbH & Co. KGIndustry (pharma, biotech, devices)
- Study start
- Dec 2003
- Primary completion
- Jun 2006 (actual)
- Study completion
- Jun 2009 (actual)
- First posted
- 31 Mar 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Safety and efficacy of recombinant birch pollen allergen in the treatment of allergic rhinoconjunctivitis
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Positive Skin Prick Test reaction to birch pollen
- Positive RAST result to birch pollen
- Positive Provocation Test result to birch pollen
Key exclusion criteria (2 listed)
- Serious chronic diseases
- Other perennial allergies
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Recombinant birch pollen | Biological | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Mar 2013.
- Leader in specific allergy research and therapyLink provided by the sponsor.
Related trials for Birch Pollen Allergy
RecruitingPhase 1
Safety, Tolerability And Pharmacodynamics of DM-101PX in Birch Pollen Allergy
Birch Pollen Allergy
Not yet recruitingObservational study
A Study to Identify and Characterize Adults and Pediatric Participants With Cat and/or Birch Allergy
Conjunctivitis Allergic
RecruitingPhase 3
Evaluation of the Efficacy of Oral Immunotherapy With Raw Apple in Patients Allergic to Birch Pollen and Apple: Prospective, Multicenter, Comparative Phase III Study
Allergies
Not yet recruitingObservational study
Factors Determining Tolerance to Nasal Allergen Exposure With Advanced Age in a Subset of Birch Pollen Allergic Subjects
Allergic Rhinitis, Allergic Conjunctivitis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Annemie Narkus, M D principal investigator
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Recombinant birch pollen in people with Birch Pollen Allergy, run by Allergopharma GmbH & Co. KG at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Mar 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Mar 2013.