Birch Pollen AllergyPhase 2NCT00266526
Specific Immunotherapy With Recombinant Birch Pollen Allergen rBet v1-FV
A Phase 2 study testing Recombinant birch pollen in people with Birch Pollen Allergy, run by Allergopharma GmbH & Co. KG at 1 site in Germany.
Trial summary
Specific immunotherapy with recombinant birch pollen allergen rBet v1-FV 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
- Jul 2003to Jul 2005
- Phase
- Phase 2
- 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 RAST result to birch pollen
- Positive Skin Prick Test reaction to birch pollen
- positive nasal provocation test result to birch pollen extract
Who cannot join
- serious chronic diseases
- other relevant seasonal allergies
Trial locations and contacts
1 site in 1 country.
About this study
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
Specific immunotherapy with recombinant birch pollen allergen rBet v1-FV
- 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 posted19 Dec 2005 (estimated)
- Study startJul 2003
- Primary completionJul 2004
- Study completionJul 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
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
- NCT00266526
- Sponsor's protocol ID
- Al0303rB
- Status last verified
- Mar 2013
- First submitted
- 16 Dec 2005
- Last updated
- 4 Mar 2013
- Results posted
- No
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
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00266526
- Acronym / sponsor ID
- Al0303rB
- Conditions
- Birch Pollen Allergy
- Keywords
- Allergy, Birch pollen, Recombinant
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- Allergopharma GmbH & Co. KGIndustry (pharma, biotech, devices)
- Study start
- Jul 2003
- Primary completion
- Jul 2004 (actual)
- Study completion
- Jul 2005 (actual)
- First posted
- 19 Dec 2005 (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.
Specific immunotherapy with recombinant birch pollen allergen rBet v1-FV
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Positive RAST result to birch pollen
- Positive Skin Prick Test reaction to birch pollen
- positive nasal provocation test result to birch pollen extract
Key exclusion criteria (2 listed)
- serious chronic diseases
- other relevant seasonal 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 4 Mar 2013.
- Derived from this study: PubMed 26328056Klimek 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.
- Leader in specific allergy research and therapyLink provided by the sponsor.
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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 2 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 4 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
On the ClinicalTrials.gov record for NCT00266526, which also lists 1 linked publication.
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 4 Mar 2013.