Determination of Accuracy in Measurement of Total Immunoglobulin E Using a Test Device in Atopic Subjects
NCT ID: NCT02758548
Last Updated: 2016-11-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE2
193 participants
INTERVENTIONAL
2016-03-31
2016-05-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
120 patients with atopic conditions and approximately 40 healthy subjects will be enrolled. Fingerstick capillary blood samples will be collected and tested in the POCT device. Venous samples will be collected and sent to a reference laboratory for measurement of serum total IgE using the reference immunoassay method.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NA
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Capillary Blood Sampling
Capillary blood sampling, collected as two fingerprick samples with POCT device and two venous samples
Blood sample
Fingerprick and venous
POCT device
Investigational device
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Blood sample
Fingerprick and venous
POCT device
Investigational device
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Subjects or legal guardians who are able to give informed consent
* Subjects who have received anti-IgE antibody treatment
* Subjects who have elevated IgE levels for reasons other than allergic conditions
* Subjects who are able to give informed consent for participation in the study according to local requirements / law.
Exclusion Criteria
* Subjects with a suspected or confirmed clinical diagnosis of an atopic condition
6 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Novartis Pharmaceuticals
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Novartis Investigative Site
Hamburg, , Germany
Novartis Investigative Site
Lübeck, , Germany
Novartis Investigative Site
Padua, PD, Italy
Novartis Investigative Site
Pisa, PI, Italy
Novartis Investigative Site
Roma, RM, Italy
Novartis Investigative Site
Harderwijk, Netherlands, Netherlands
Novartis Investigative Site
Almelo, , Netherlands
Novartis Investigative Site
Sabadell, Barcelona, Spain
Novartis Investigative Site
Valencia, Valencia, Spain
Novartis Investigative Site
Chertsey, Surrey, United Kingdom
Novartis Investigative Site
Bradford, West Yorkshire, United Kingdom
Novartis Investigative Site
Manchester, , United Kingdom
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
CDIGE0012201
Identifier Type: -
Identifier Source: org_study_id