House Dust Mite AllergyPhase 4NCT00263549
Safety and Efficacy of House Dust Mite Allergen Extract in the Treatment of Allergic Rhinoconjunctivitis
A Phase 4 study testing House dust mite Novo Helisen Depot in people with House Dust Mite Allergy, run by Allergopharma GmbH & Co. KG at 1 site in Germany.
Trial summary
The trial is performed to assess efficacy and safety of Novo-Helisen Depot in allergic Rhinoconjunctivitis Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- House Dust Mite Allergy
- What is being tested?
- House dust mite Novo Helisen Depot
- How many people
- Not given
- Where
- 1 siteGermany
- Study dates
- Sep 2002to Feb 2006
- Phase
- Phase 4
- 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 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Positive skin prick test to house dust mite,
- Positive RAST test to house dust mite,
- Positive provocation test result to house dust mite,
Who cannot join
- Serious chronic diseases,
- Other perennial allergies
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Multicenter Study for Evaluation of Efficacy and Safety of Perennial Specific Immunotherapy With a Depot House Dust Mite Allergen Extract (D. Pteronyssinus 100%) in Patients With House Dust Mite Sensitivity
The trial is performed to assess efficacy and safety of Novo-Helisen Depot in allergic Rhinoconjunctivitis
- Conditions
- House Dust Mite Allergy
- Being tested
- House dust mite Novo Helisen Depot
- Keywords
- House dust mite,, Allergy
- Medical subject headings
- Dust Mite Allergy, Hypersensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
House dust mite Novo Helisen DepotBiological
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2005 (estimated)
- Study startSep 2002
- Primary completionFeb 2005
- Study completionFeb 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for House Dust Mite 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 4
- 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
- NCT00263549
- Sponsor's protocol ID
- Al0201NH
- Status last verified
- Feb 2013
- First submitted
- 8 Dec 2005
- Last updated
- 11 Feb 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter Study for Evaluation of Efficacy and Safety of Perennial Specific Immunotherapy With a Depot House Dust Mite Allergen Extract (D. Pteronyssinus 100%) in Patients With House Dust Mite Sensitivity
- ClinicalTrials.gov ID
- NCT00263549
- Acronym / sponsor ID
- Al0201NH
- Conditions
- House Dust Mite Allergy
- Keywords
- House dust mite,, Allergy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- Allergopharma GmbH & Co. KGIndustry (pharma, biotech, devices)
- Study start
- Sep 2002
- Primary completion
- Feb 2005 (actual)
- Study completion
- Feb 2006 (actual)
- First posted
- 9 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.
The trial is performed to assess efficacy and safety of Novo-Helisen Depot in allergic Rhinoconjunctivitis
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Positive skin prick test to house dust mite,
- Positive RAST test to house dust mite,
- Positive provocation test result to house dust mite,
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 |
|---|---|---|
| House dust mite Novo Helisen Depot | 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 Feb 2013.
- 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 4 study testing House dust mite Novo Helisen Depot in people with House Dust Mite 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 Feb 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 Feb 2013.