Birch Pollen-Related RhinoconjunctivitisPhase 1NCT00889460
Safety and Tolerability Study of rBet v1 SLIT Tablets
A Phase 1 study testing rBet v 1 in people with Birch Pollen-Related Rhinoconjunctivitis and Rhinitis, Allergic, Seasonal, run by Stallergenes Greer at 1 site in Denmark.
Trial summary
The purpose of this study is to determine the safety and tolerability of several doses of r Bet v1 administered as sub-lingual tablets in subjects sensitised to birch pollen. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Birch Pollen-Related Rhinoconjunctivitis, Rhinitis, Allergic, Seasonal
- What is being tested?
- rBet v 1
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 55 participants
- Where
- 1 siteDenmark
- Study dates
- Nov 2007to Apr 2008
- Phase
- Phase 1
- 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
- written consent
- Male or female subject from 18 to 60 years old and in general good health
- For woman of child bearing potential:
- Symptoms of birch pollen induced allergic rhinitis for at least the last 2 years.
- Sensitisation to birch pollen as demonstrated with a positive SPT to birch pollen and specific IgE level (birch pollen and r Bet v1) >0.70 kU/L at screening.
- FEV1 at least of 80% of predicted values at screening.
- Subject accepting to comply fully with the protocol.
Who cannot join
- Past or current disease which as judged by the Investigator, may affect the outcome of this study.
- History of life-threatening asthma,
- Asthma requiring daily treatment (whatever the pharmaceutical class).
- Pregnant or lactating woman.
- Subject being treated with inhaled steroids within 4 weeks prior to screening visit or within 12 weeks prior to screening visit.
- Subject who previously received desensitisation treatment to birch pollen and/or other betulaceae (e.g., hazel tree, alder) or who plan to start desensitisation treatment during this study.
- Symptoms during the treatment phase due to a sensitivity to a second allergen.
- Subjects treated with ongoing immunotherapy with another allergen
Trial locations and contacts
1 site in 1 country.
Denmark1 site
National University Hospital - Allergy Unit 4222
Copenhagen, 2100
About this study
Official title: Phase I Study to re-Investigate the Safety, Tolerability and Pharmacodynamic Effects of SLIT(Tablets) With Recombinant Bet v1 Given in Single Rising Doses and in Multi Dose Regimens to Subjects Sensitised to Birch Pollen
The purpose of this study is to determine the safety and tolerability of several doses of r Bet v1 administered as sub-lingual tablets in subjects sensitised to birch pollen.
- Being tested
- rBet v 1, Placebo
- Keywords
- rBet v 1, Birch pollen allergy, Sublingual Immunotherapy
- Medical subject headings
- Rhinitis, Allergic, Seasonal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
rBet v 1Biological
Also called rBet v 1.0101
Two tablets (1 placebo + 1 rBet v 1 or 2 rBet v 1) were administered every day over 2 weeks with a 2-day break for the week-end. Administered doses ranged from 12.5 to 100 µg rBet v 1.
PlaceboBiological
Two matching placebo tablets were administered every day over 2 weeks with a 2-day break for the week-end.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Placebo comparator | Placebo group Receives: Biological: Placebo |
| 2 | Experimental | rBet v 1 tablets Receives: Biological: rBet v 1 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Local tolerability
Measured: Assessed every day over 2 weeks
Global safety
Measured: Assessed every day over 2 weeks
Secondary outcomes (1)
Immunological markers (IgE and IgG4)
Measured: Between selection and follow-up visit (up to 18 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2009 (estimated)
- Study startNov 2007
- Primary completionApr 2008
- Study completionApr 2008
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-Related RhinoconjunctivitisStudies 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 55 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stallergenes Greer
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Quintiles, Inc.
- Investigators
- Hans-Jorgen MALLING, Pr. MD, Principal investigator, National University Hospital - Copenhagen - DENMARK
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00889460
- Sponsor's protocol ID
- VO58.07 DK
- Status last verified
- Apr 2009
- First submitted
- 28 Apr 2009
- Last updated
- 29 Apr 2009
- Results posted
- No
- Data monitoring committee
- No
Publications
L. Winther, L.K. Poulsen, B. Robin, M. Mélac, H. Malling Safety and Tolerability of Recombinant Bet v 1 (rBet v 1) Tablets in Sublingual Immunotherapy (SLIT) The Journal of Allergy and Clinical Immunology February 2009 (Vol. 123, Issue 2, Page S215)
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I Study to re-Investigate the Safety, Tolerability and Pharmacodynamic Effects of SLIT(Tablets) With Recombinant Bet v1 Given in Single Rising Doses and in Multi Dose Regimens to Subjects Sensitised to Birch Pollen
- ClinicalTrials.gov ID
- NCT00889460
- Acronym / sponsor ID
- VO58.07 DK
- Keywords
- rBet v 1, Birch pollen allergy, Sublingual Immunotherapy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 55 participants (actual)
- Lead sponsor
- Stallergenes GreerIndustry (pharma, biotech, devices)
- Collaborators
- Quintiles, Inc.
- Study start
- Nov 2007
- Primary completion
- Apr 2008 (actual)
- Study completion
- Apr 2008 (actual)
- First posted
- 29 Apr 2009 (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.
The purpose of this study is to determine the safety and tolerability of several doses of r Bet v1 administered as sub-lingual tablets in subjects sensitised to birch pollen.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Placebo comparator | Biological: PlaceboPlacebo group |
| 2 | Experimental | Biological: rBet v 1rBet v 1 tablets |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- written consent
- Male or female subject from 18 to 60 years old and in general good health
- For woman of child bearing potential:
- Symptoms of birch pollen induced allergic rhinitis for at least the last 2 years.
- Sensitisation to birch pollen as demonstrated with a positive SPT to birch pollen and specific IgE level (birch pollen and r Bet v1) >0.70 kU/L at screening.
Key exclusion criteria (8 listed)
- Past or current disease which as judged by the Investigator, may affect the outcome of this study.
- History of life-threatening asthma,
- Asthma requiring daily treatment (whatever the pharmaceutical class).
- Pregnant or lactating woman.
- Subject being treated with inhaled steroids within 4 weeks prior to screening visit or within 12 weeks prior to screening visit.
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 |
|---|---|---|
| rBet v 1Also: rBet v 1.0101Two tablets (1 placebo + 1 rBet v 1 or 2 rBet v 1) were administered every day over 2 weeks with a 2-day break for the week-end. Administered doses ranged from 12.5 to 100 µg rBet v 1. | Biological | 2 |
| PlaceboTwo matching placebo tablets were administered every day over 2 weeks with a 2-day break for the week-end. | Biological | 1 |
Primary outcome
Local tolerability
Time frame: Assessed every day over 2 weeks
Global safety
Time frame: Assessed every day over 2 weeks
1 secondary outcome
Immunological markers (IgE and IgG4)
Time frame: Between selection and follow-up visit (up to 18 weeks)
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 29 Apr 2009.
- Results publicationL. Winther, L.K. Poulsen, B. Robin, M. Mélac, H. Malling Safety and Tolerability of Recombinant Bet v 1 (rBet v 1) Tablets in Sublingual Immunotherapy (SLIT) The Journal of Allergy and Clinical Immunology February 2009 (Vol. 123, Issue 2, Page S215)
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.
Hans-Jorgen MALLING, Pr. MD principal investigator
National University Hospital - Copenhagen - DENMARK
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing rBet v 1 in people with Birch Pollen-Related Rhinoconjunctivitis and Rhinitis, Allergic, Seasonal, run by Stallergenes Greer at 1 site in Denmark.
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 7 inclusion and 8 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 29 Apr 2009. 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 Denmark. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Local tolerability (time frame: Assessed every day over 2 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00889460, 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 29 Apr 2009.