UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000063433 |
|---|---|
| Receipt number | R000072603 |
| Scientific Title | Efficacy and Safety of Early Treatment for Acute Attacks of Hereditary Angioedema: A Systematic Review |
| Date of disclosure of the study information | 2026/10/27 |
| Last modified on | 2026/10/27 19:27:50 |
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Basic information
Public title
Should Acute Attacks of Hereditary Angioedema Be Treated Early?
Acronym
Early Treatment of HAE Attacks
Scientific Title
Efficacy and Safety of Early Treatment for Acute Attacks of Hereditary Angioedema: A Systematic Review
Scientific Title:Acronym
HAE Early Treatment Systematic Review
Region
| Japan |
Condition
Condition
Hereditary angioedema (HAE)
Classification by specialty
| Clinical immunology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To systematically evaluate the efficacy and safety of early treatment for acute attacks of hereditary angioedema (HAE) based on existing clinical studies. Specifically, this review aims to assess the effects of early treatment compared with delayed or no treatment on mortality, attack duration, time to symptom improvement, and serious adverse events.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The primary outcomes are attack duration and time to symptom improvement following early treatment of acute hereditary angioedema (HAE) attacks. Outcomes include time to complete attack resolution and time to onset of symptom relief, as reported in the included studies.
Key secondary outcomes
The secondary outcomes are mortality and the incidence of serious adverse events associated with early treatment of acute hereditary angioedema (HAE) attacks.
Base
Study type
Others,meta-analysis etc
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Clinical studies involving patients with acute attacks of hereditary angioedema (HAE) that evaluate the efficacy or safety of early treatment will be eligible. Studies comparing early treatment with delayed or no treatment will be prioritized. Studies reporting clinical outcomes of on-demand treatment for acute HAE attacks will also be considered. No restrictions will be applied regarding age or sex.
Key exclusion criteria
Studies not evaluating treatment of acute HAE attacks, studies focusing exclusively on long-term or short-term prophylaxis, studies without relevant clinical outcomes of acute attacks, reviews and systematic reviews without original patient data, animal studies, and basic research will be excluded.
Target sample size
Research contact person
Name of lead principal investigator
| 1st name | Tomoya |
| Middle name | |
| Last name | Hirose |
Organization
Osaka University Graduate School of Medicine
Division name
Department of Traumatology and Acute Critical Medicine
Zip code
565-0871
Address
2-15 Yamadaoka Suita, Osaka 565-0871, Japan
TEL
06-6879-5707
htomoya1979@hp-emerg.med.osaka-u.ac.jp
Public contact
Name of contact person
| 1st name | Tomoya |
| Middle name | |
| Last name | Hirose |
Organization
Osaka University Graduate School of Medicine
Division name
Department of Traumatology and Acute Critical Medicine
Zip code
565-0871
Address
2-15 Yamadaoka Suita, Osaka 565-0871, Japan
TEL
06-6879-5707
Homepage URL
htomoya1979@hp-emerg.med.osaka-u.ac.jp
Sponsor or person
Institute
Osaka University
Institute
Department
Personal name
Tomoya Hirose
Funding Source
Organization
others
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
N/A
Address
N/A
Tel
N/A
N/A
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 10 | Month | 27 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Preinitiation
Date of protocol fixation
| 2026 | Year | 10 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2026 | Year | 10 | Month | 27 | Day |
Last follow-up date
| 2026 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This study is a systematic review addressing Clinical Question 4 (CQ4) of the clinical practice guidelines for hereditary angioedema (HAE): "Should all acute attacks of HAE be treated early?" A meta-analysis will be conducted if quantitative synthesis is deemed appropriate, taking into account the clinical and methodological heterogeneity among the included studies.
Management information
Registered date
| 2026 | Year | 10 | Month | 27 | Day |
Last modified on
| 2026 | Year | 10 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000072603
