Wasp Venom Allergic PatientsNCT00794287
Performance of CAST (Cellular Antigen Stimulation Test) in Patients With Wasp Venom Allergy: Evaluation of Neutralizing IgG Subclasses
An observational study of Wasp Venom Allergic Patients, run by University of Zurich at 1 site in Switzerland.
Trial summary
To determine which subclass of IgG in the serum of patients undergoing SIT against wasp venom is able to neutralize the allergen, and therefore to prevent a positive CAST Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Wasp Venom Allergic Patients
- What is being tested?
- Taking blood samples
- How many people
- 0 participants
- Where
- 1 siteSwitzerland
- Study dates
- Jan 2009to Dec 2010
- Phase
- Observational
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Wasp venom allergic patients grade III and IV according to H.L. Müller in the age group of 18-75 years
Who may be able to join
- male and female patient with allergy to wasp venom grade III and IV according to H.L. Müller
- 18-75 years
- planned SIT against wasp venom or finished 5 years SIT against wsp venom (10/10)
Who cannot join
- oral corticosteroids
- chromogycin
- ketotifen
- immunosuppressive drugs within the last 2 years
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Performance of CAST (Cellular Antigen Stiumulation Test)in Patients With Wasp Venom Allergy. Evaluation of Neutralizing IgG Subclasses
To determine which subclass of IgG in the serum of patients undergoing SIT against wasp venom is able to neutralize the allergen, and therefore to prevent a positive CAST
- Conditions
- Wasp Venom Allergic Patients
- Being tested
- Taking blood samples
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Taking blood samplesOther
No intervention is done. Only blood samples are taken.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Hymenoptera allergic patients before allergen specific immunotherapy Receives: Other: Taking blood samples | |
| 2 | Hymenoptera allergic patients after allergen specific immunotherapy Receives: Other: Taking blood samples |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2008 (estimated)
- Study startJan 2009
- Primary completionDec 2010 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Wasp Venom Allergic PatientsStudies of the same condition, open and under way.
- More trials run by University of ZurichThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Zurich
- Sponsor type
- University, hospital or other
- Investigators
- 01 Studienregister MasterAdmins, Study director, UniversitaetsSpital Zuerich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00794287
- Sponsor's protocol ID
- ZU-AgNT-004
- Status last verified
- Jun 2015
- First submitted
- 19 Nov 2008
- Last updated
- 4 Jun 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Performance of CAST (Cellular Antigen Stiumulation Test)in Patients With Wasp Venom Allergy. Evaluation of Neutralizing IgG Subclasses
- ClinicalTrials.gov ID
- NCT00794287
- Acronym / sponsor ID
- ZU-AgNT-004
- Conditions
- Wasp Venom Allergic Patients
- Study type
- Observational
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of ZurichUniversity, hospital or other
- Study start
- Jan 2009
- Primary completion
- Dec 2010 (estimated)
- First posted
- 20 Nov 2008 (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.
To determine which subclass of IgG in the serum of patients undergoing SIT against wasp venom is able to neutralize the allergen, and therefore to prevent a positive CAST
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | – | Other: Taking blood samplesHymenoptera allergic patients before allergen specific immunotherapy |
| 2 | – | Other: Taking blood samplesHymenoptera allergic patients after allergen specific immunotherapy |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Wasp venom allergic patients grade III and IV according to H.L. Müller in the age group of 18-75 years
Key inclusion criteria (3 listed)
- male and female patient with allergy to wasp venom grade III and IV according to H.L. Müller
- 18-75 years
- planned SIT against wasp venom or finished 5 years SIT against wsp venom (10/10)
Key exclusion criteria (4 listed)
- oral corticosteroids
- chromogycin
- ketotifen
- immunosuppressive drugs within the last 2 years
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 |
|---|---|---|
| Taking blood samplesNo intervention is done. Only blood samples are taken. | Other | 1, 2 |
Primary outcome
Not reported in the source record.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2015.
Related trials for Wasp Venom Allergic Patients
Not yet recruiting
Virtual-reality Induced Immune Modulation in Allergic Patients
Hymenoptera Venom Allergy
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.
01 Studienregister MasterAdmins study director
UniversitaetsSpital Zuerich
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Wasp Venom Allergic Patients, run by University of Zurich at 1 site in Switzerland.
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 4 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: withdrawn, as of the sponsor's last update on 4 Jun 2015. 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 Switzerland. 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.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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 4 Jun 2015.