UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000055644 |
|---|---|
| Receipt number | R000063558 |
| Scientific Title | Exploring the clinical practice and prevalence of HAE in patients visiting hospital general medicine departments in Japan |
| Date of disclosure of the study information | 2024/09/30 |
| Last modified on | 2024/10/02 16:10:05 |
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Basic information
Public title
Exploring the clinical practice and prevalence of HAE in patients visiting hospital general medicine departments in Japan
Acronym
EXPLORE-HAE Study
Scientific Title
Exploring the clinical practice and prevalence of HAE in patients visiting hospital general medicine departments in Japan
Scientific Title:Acronym
EXPLORE-HAE Study
Region
| Japan |
Condition
Condition
Hereditary angioedema (HAE)
Classification by specialty
| Medicine in general |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To determine the prevalence of HAE in general practice and ultimately identify patients with suspected HAE based on the patient population background of this study and incorporate a diagnostic algorithm for HAE into clinical guidelines.
Basic objectives2
Others
Basic objectives -Others
Diagnostics
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
The prevalence of HAE will be tabulated by the following categories
(1) Overall subject population
(2) NSAP cases
(3) Cases with recurrent generalized or localized edema (excluding NSAP)
Key secondary outcomes
Descriptive evaluation of the clinical characteristics of patients with and without HAE in the group of patients with HAE who have NSAP and non-NSAP with recurrent generalized or localized edema, including hematology, blood biochemical tests, and abdominal imaging studies.
Base
Study type
Observational
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
Patients who meet all of the following criteria
(1) Those with C1-INH and C4 measured within the practice
(2) Patients with recurrent generalized or local edema or NSAP
(3) Patients who consent to this study in writing.
Key exclusion criteria
Persons who are judged by the investigators to be inappropriate to participate in the study.
Target sample size
2000
Research contact person
Name of lead principal investigator
| 1st name | Masaki |
| Middle name | |
| Last name | Tago |
Organization
Saga University Hospital
Division name
Department of General Medicine
Zip code
849-8501
Address
5-1-1 Nabeshima, Saga City, Saga, 849-8501 Japan
TEL
0952-31-6511
tagomas@cc.saga-u.ac.jp
Public contact
Name of contact person
| 1st name | Masaki |
| Middle name | |
| Last name | Tago |
Organization
Saga University Hospital
Division name
Department of General Medicine
Zip code
849-8501
Address
5-1-1 Nabeshima, Saga City, Saga, 849-8501 Japan
TEL
0952-31-6511
Homepage URL
tagomas@cc.saga-u.ac.jp
Sponsor or person
Institute
CSL Behring K.K.
Institute
Department
Personal name
Naoki Terasaka
Funding Source
Organization
CSL Behring K.K.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Clinical Research Center, Saga University Hospital
Address
5-1-1 Nabeshima, Saga City, Saga, Japan
Tel
0952-34-3400
clinstudycenter@mail.admin.saga-u.ac.jp
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
JR広島病院（広島県）
佐賀大学医学部附属病院（佐賀県）
東邦大学医療センター大森病院（東京都）
福岡大学病院（福岡県）
順天堂大学医学部附属順天堂医院（東京都）
獨協医科大学病院（栃木県）
JA尾道総合病院（広島県）
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 09 | Month | 30 | 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
Open public recruiting
Date of protocol fixation
| 2024 | Year | 07 | Month | 30 | Day |
Date of IRB
| 2024 | Year | 09 | Month | 02 | Day |
Anticipated trial start date
| 2024 | Year | 10 | Month | 02 | Day |
Last follow-up date
| 2026 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Information to be obtained
Information used for information management
-Case number
Background on research subjects
-Date when consent was obtained, age, sex, weight
Items related to HAE
-Age at which HAE-suspected-symptoms appeared
-Duration from HAE-suspected-symptoms appeared to the patient visited to the medical institution conducting this study.
-Name of institutions and departments where the patient visited before.
-Family history of HAE
-Presence or absence of the following symptoms
Edema / Stomach pain / Nausea / Vomiting / Diarrhea / Dizziness / Low blood pressure / Malaise / Dyspnea / Shortness of breath / Skin rash
-Value of C1-INH, C4 level on blood test
-Diagnosis of HAE
Items related to the definition of NSAP
-Implements of Abdominal image test (echography, CT etc).
-Value of blood tests:
Blood cell: white blood cell count, red blood cell count, hemoglobin, hematocrit, MCV, MCH, MCHC, platelet count, white blood cell classification
Liver: AST, ALT, gamma-GT, ALP, total bilirubin, LDH, total protein, albumin
Inflammation: CRP
Kidney: BUN, creatinine, eGFR
Pancreas: amylase
Electrolytes: Na, K, Cl
Management information
Registered date
| 2024 | Year | 09 | Month | 27 | Day |
Last modified on
| 2024 | Year | 10 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000063558
