AllergyPhase 3NCT00554983
Efficacy and Safety From a Recombinant Folding Variant of Bet v 1
A Phase 3 study testing recombinant birch pollen allergen in people with Allergy, run by Allergopharma GmbH & Co. KG at 1 site in Germany.
Trial summary
Efficacy and Safety from a recombinant folding variant of Bet v 1 Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Allergy
- What is being tested?
- recombinant birch pollen allergen
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 255 participants
- Where
- 1 siteGermany
- Study dates
- Sep 2007to May 2012
- 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
- Allergic rhinoconjunctivitis attributable to birch pollen
- Positive SPT
- Positive EAST
- Positive specific provocation test
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 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
Efficacy and Safety from a recombinant folding variant of Bet v 1
- Conditions
- Allergy
- Being tested
- recombinant birch pollen allergen, placebo
- Keywords
- Recombinant birch pollen allergy, IgE-mediated allergic disease attributed to birch pollen
- 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 pollen allergenBiological
subcutaneous injections (s.c.). Dosage escalation phase from 0.75 to 80 microgram maintenance dose s.c. injections of 80 microgram
placeboBiological
subcutaneous injections (s.c.). Dosage escalation phase from 0.75 to 80 microgram maintenance dose s.c. injections of 80 microgram
| Study group | Role | What they receive |
|---|---|---|
| 2 | Placebo comparator | Not described Receives: Biological: placebo |
| 1 | Experimental | Not described Receives: Biological: recombinant birch pollen allergen |
What is being measured
The primary outcome is the main question the study is designed to answer.
Symptom-Medication-Score
Measured: during pollen season
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2007 (estimated)
- Study startSep 2007
- Primary completionJun 2010
- Study completionMay 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Who is masked
- Participant, Investigator
- Enrolment
- 255 participants (actual)
Sponsor and investigators
- Lead sponsor
- Allergopharma GmbH & Co. KG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ludger Klimek, Professor, Principal investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00554983
- Sponsor's protocol ID
- AL0702rB
- Other IDs
- 2007-001029-84
- Status last verified
- Nov 2013
- First submitted
- 6 Nov 2007
- Last updated
- 8 Nov 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT00554983
- Acronym / sponsor ID
- AL0702rB
- Conditions
- Allergy
- Keywords
- Recombinant birch pollen allergy, IgE-mediated allergic disease attributed to birch pollen
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 255 participants (actual)
- Lead sponsor
- Allergopharma GmbH & Co. KGIndustry (pharma, biotech, devices)
- Study start
- Sep 2007
- Primary completion
- Jun 2010 (actual)
- Study completion
- May 2012 (actual)
- First posted
- 7 Nov 2007 (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.
Efficacy and Safety from a recombinant folding variant of Bet v 1
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 2 | Placebo comparator | Biological: placebo |
| 1 | Experimental | Biological: recombinant birch pollen allergen |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Allergic rhinoconjunctivitis attributable to birch pollen
- Positive SPT
- Positive EAST
- Positive specific provocation test
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 allergensubcutaneous injections (s.c.). Dosage escalation phase from 0.75 to 80 microgram maintenance dose s.c. injections of 80 microgram | Biological | 1 |
| placebosubcutaneous injections (s.c.). Dosage escalation phase from 0.75 to 80 microgram maintenance dose s.c. injections of 80 microgram | Biological | 2 |
Primary outcome
Symptom-Medication-Score
Time frame: during pollen season
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 8 Nov 2013.
- Leader in specific allergy research and therapyLink provided by the sponsor.
- Click here for information about this trial in the European Clinical Trials RegisterLink 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.
Ludger Klimek, Professor 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 allergen in people with 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 4 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 8 Nov 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. Some participants in this study may receive a placebo. 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.
What does the primary outcome measure?
Symptom-Medication-Score (time frame: during pollen season). It is what the study was designed to measure, not a finding.
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 8 Nov 2013.