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Mechanisms of Anaphylaxis

Study Purpose

The purpose of this study is to explore different mechanisms for anaphylaxis and find novel biomarkers for this hypersensitivity syndrome. The study participants are patients with anaphylaxis, patients with mild allergic reactions, and patients with febrile transfusion reactions. The investigators will also include a group of healthy controls.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

Yes
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Observational [Patient Registry]
Eligible Ages 16 Years and Over
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

According to the specific cohort: 1. Diagnosis of anaphylaxis. 2. Mild allergic reaction. 3. Febrile transfusion reaction. 4. Healthy, no known allergic disease.

Exclusion Criteria:

Suspicion or diagnosed sepsis Children

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT03182491
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Haukeland University Hospital
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Torunn O Apelseth, MD, PhDMorten Y Isaksen, MD
Principal Investigator Affiliation Haukeland University HospitalHaukeland University Hospital
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other
Overall Status Active, not recruiting
Countries Norway
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Anaphylaxis, Allergy, Transfusion Reaction, Febrile Transfusion Reaction
Arms & Interventions

Arms

: Anaphylaxis

: Febrile transfusion reactions

: Mild allergic reactions

: Healthy controls

Interventions

Diagnostic Test: - Biomarkers (platelet activating factor [PAF], anaphylatoxins) and basophil activation test (BAT)

Analysis of biomarkers and basophil activation test

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

Haukeland University Hospital, Bergen, Norway

Status

Address

Haukeland University Hospital

Bergen, ,

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