Drug HypersensitivityNCT07390370
Establishment of a Registry for Immediate Drug Allergy
An observational study of Drug Hypersensitivity, run by Yonsei University.
Trial summary
Immediate drug hypersensitivity reactions are acute adverse reactions that occur within one hour of drug administration and can result in life-threatening symptoms such as urticaria, angioedema, and anaphylaxis. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Drug Hypersensitivity
- How many people
- 200 participants
- Where
- No sites listed yet
- Study dates
- 1 Feb 2026to 31 Dec 2030
- How long will I take part?
- 4 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients aged 19 years or older diagnosed with immediate hypersensitivity reactions (such as rash, urticaria, angioedema, anaphylaxis, etc.) within 1 hour after drug administration.
Who may be able to join
- Adult patients aged 19 years or older diagnosed with immediate hypersensitivity reactions (such as rash, urticaria, angioedema, anaphylaxis, etc.) within 1 hour after drug administration."
- Utilization of samples and clinical data from patients with immediate drug hypersensitivity who consented to participate in secondary research, registered in the study 'Establishment of a Registry for Identifying Factors Related to Diagnosis, Treatment, and Prognosis in Allergic Disease Patients' (Project Number 4-2013-0397).
Who cannot join
- Participants who do not consent to participate in the study."
- Children and adolescents under the age of 19."
- Participants who are unable to read or understand the consent form."
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Immediate drug hypersensitivity reactions are acute adverse reactions that occur within one hour of drug administration and can result in life-threatening symptoms such as urticaria, angioedema, and anaphylaxis. Current diagnostic methods have high false-negative and false-positive rates, and standardized testing for non-IgE-mediated reactions (e.g., MRGPRX2) is lacking. This creates significant gaps in patient safety and clinical decision-making.
The study aims to establish a registry of patients with immediate drug hypersensitivity reactions to analyze clinical characteristics and investigate the underlying mechanisms of IgE-mediated and non-IgE-mediated reactions. Blood samples will be collected prospectively, using residual serum from routine clinical tests where available, to minimize additional blood draws. Mechanistic analyses will focus on IgE-mediated and non-IgE-mediated pathways, including MRGPRX2 expression in mast cells and basophils, and measurement of active β-tryptase as a biomarker for anaphylaxis.
Read more
In addition, a retrospective review will be conducted of medical records from the last 10 years to identify causative drugs and classify the underlying mechanisms of hypersensitivity. Based on this, specific target drugs will be selected for further prospective analysis. Data and biospecimens from participants in an existing allergy registry, who consent to secondary use, will also be included in the study.
Through the integration of clinical data and multi-layered biomarker analysis, the study aims to improve understanding of immediate drug hypersensitivity mechanisms and develop predictive models. Ultimately, this research will contribute to the establishment of personalized diagnosis, prevention, and treatment strategies for drug allergies.
- Conditions
- Drug Hypersensitivity
- Medical subject headings
- Drug Hypersensitivity
What is being measured
The primary outcome is the main question the study is designed to answer.
Endotype Classification and Basophil Activation in Immediate Drug Hypersensitivity
Derivation and classification of endotype clusters in immediate drug hypersensitivity reactions based on basophil/mast cell activation markers and mediator-release profiles.
Measured: 4 years
Secondary outcomes (1)
Biomarker Associations with Endotypes and Clinical Phenotypes in Drug Hypersensitivity
- Association of MRGPRX2-related markers with endotype clusters and clinical phenotypes in immediate drug hypersensitivity reactions.
- Association of serum β-tryptase with endotype clusters and anaphylaxis/severity phenotypes.
- Exploratory identification of candidate biomarkers from stool and/or skin specimens associated with endotype clusters.
Measured: 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2026
- Study start1 Feb 2026 (estimated)
- Primary completion15 Dec 2030 (estimated)
- Study completion31 Dec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Drug HypersensitivityStudies of the same condition, open and under way.
- More trials run by Yonsei UniversityThe 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
- Other
- Enrolment
- 200 participants (estimated)
- Target duration
- 4 Years
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07390370
- Sponsor's protocol ID
- 4-2025-1428
- Status last verified
- Jan 2026
- First submitted
- 28 Jan 2026
- Last updated
- 5 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: We plan to share individual participant data (IPD) from this registry study with qualified researchers conducting non-commercial research. The shared data will include clinical data, laboratory test results, and biological samples (e.g., blood, stool). Data sharing will be subject to the following conditions: 1. Researchers must submit a formal request detailing the proposed research and data use. 2. Data will be de-identified to protect confidentiality and ensure ethical compliance. 3. Data is for non-commercial use only and cannot be used commercially without prior consent. 4. Recipients must obtain ethics or IRB approval. 5. Data will be shared via a secure platform, and recipients must sign a data use agreement (DUA). 6. Access will be provided for 5 years post-study, after which data will be archived or deleted.
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Establishment of a Registry for Immediate Drug Allergy
- ClinicalTrials.gov ID
- NCT07390370
- Acronym / sponsor ID
- 4-2025-1428
- Conditions
- Drug Hypersensitivity
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- 1 Feb 2026 (estimated)
- Primary completion
- 15 Dec 2030 (estimated)
- Study completion
- 31 Dec 2030 (estimated)
- First posted
- 5 Feb 2026 (actual)
- 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.
Immediate drug hypersensitivity reactions are acute adverse reactions that occur within one hour of drug administration and can result in life-threatening symptoms such as urticaria, angioedema, and anaphylaxis. Current diagnostic methods have high false-negative and false-positive rates, and standardized testing for non-IgE-mediated reactions (e.g., MRGPRX2) is lacking. This creates significant gaps in patient safety and clinical decision-making.
The study aims to establish a registry of patients with immediate drug hypersensitivity reactions to analyze clinical characteristics and investigate the underlying mechanisms of IgE-mediated and non-IgE-mediated reactions. Blood samples will be collected prospectively, using residual serum from routine clinical tests where available, to minimize additional blood draws. Mechanistic analyses will focus on IgE-mediated and non-IgE-mediated pathways, including MRGPRX2 expression in mast cells and basophils, and measurement of active β-tryptase as a biomarker for anaphylaxis.
In addition, a retrospective review will be conducted of medical records from the last 10 years to identify causative drugs and classify the underlying mechanisms of hypersensitivity. Based on this, specific target drugs will be selected for further prospective analysis. Data and biospecimens from participants in an existing allergy registry, who consent to secondary use, will also be included in the study.
Through the integration of clinical data and multi-layered biomarker analysis, the study aims to improve understanding of immediate drug hypersensitivity mechanisms and develop predictive models. Ultimately, this research will contribute to the establishment of personalized diagnosis, prevention, and treatment strategies for drug allergies.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Target follow-up
- 4 Years
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients aged 19 years or older diagnosed with immediate hypersensitivity reactions (such as rash, urticaria, angioedema, anaphylaxis, etc.) within 1 hour after drug administration.
Key inclusion criteria (2 listed)
- Adult patients aged 19 years or older diagnosed with immediate hypersensitivity reactions (such as rash, urticaria, angioedema, anaphylaxis, etc.) within 1 hour after drug administration."
- Utilization of samples and clinical data from patients with immediate drug hypersensitivity who consented to participate in secondary research, registered in the study 'Establishment of a Registry for Identifying Factors Related to Diagnosis, Treatment, and Prognosis in Allergic Disease Patients' (Project Number 4-2013-0397).
Key exclusion criteria (3 listed)
- Participants who do not consent to participate in the study."
- Children and adolescents under the age of 19."
- Participants who are unable to read or understand the consent form."
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Endotype Classification and Basophil Activation in Immediate Drug Hypersensitivity
Time frame: 4 years
Derivation and classification of endotype clusters in immediate drug hypersensitivity reactions based on basophil/mast cell activation markers and mediator-release profiles.
1 secondary outcome
Biomarker Associations with Endotypes and Clinical Phenotypes in Drug Hypersensitivity
Time frame: 4 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2026.
- Individual participant dataSharing planned: Undecided. We plan to share individual participant data (IPD) from this registry study with qualified researchers conducting non-commercial research. The shared data will include clinical data, laboratory test results, and biological samples (e.g., blood, stool). Data sharing will be subject to the following conditions: 1. Researchers must submit a formal request detailing the proposed research and data use. 2. Data will be de-identified to protect confidentiality and ensure ethical compliance. 3. Data is for non-commercial use only and cannot be used commercially without prior consent. 4. Recipients must obtain ethics or IRB approval. 5. Data will be shared via a secure platform, and recipients must sign a data use agreement (DUA). 6. Access will be provided for 5 years post-study, after which data will be archived or deleted.
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Drug Hypersensitivity, run by Yonsei University.
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 2 inclusion and 3 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: opening soon, as of the sponsor's last update on 5 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kyung Hee Park, P (+82-2-2228-1947, white182@yuhs.ac), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Endotype Classification and Basophil Activation in Immediate Drug Hypersensitivity (time frame: 4 years). It is what the study was designed to measure, not a finding.
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 5 Feb 2026.