Unique ID issued by UMIN | UMIN000044637 |
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Receipt number | R000050987 |
Scientific Title | Development of diagnostic and disease-monitoring biomarkers of bradykinin-mediated angioedema with or without C1-inhibitor deficiency in hereditary angioedema |
Date of disclosure of the study information | 2021/08/06 |
Last modified on | 2023/12/13 09:03:59 |
Development of diagnostic and disease-monitoring biomarkers of bradykinin-mediated angioedema with or without C1-inhibitor deficiency in hereditary angioedema
HAE BMA study
Development of diagnostic and disease-monitoring biomarkers of bradykinin-mediated angioedema with or without C1-inhibitor deficiency in hereditary angioedema
HAE BMA study
Japan |
Hereditary angioedema
Medicine in general | Hematology and clinical oncology | Nephrology |
Clinical immunology | Dermatology | Adult |
Child |
Others
NO
This observational study will be conducted to investigate the usefulness of candidate blood biomarkers in the plasma of HAE patients as novel biomarkers for HAE by quantification and activity measurements, using the proportion of cleaved HMWK (cHMWK) as a reference indicator.
Others
NA
Exploratory
Others
Not applicable
Evaluation of the following potential candidate blood biomarkers, including investigation of correlations between the candidate biomarkers and cHMWK will be performed.
-Kallikrein activity
-Sgp120 fragments
-PAI-2
-C1-INH activity (using dried blood spot (DBS))
NA
Observational
12 | years-old | <= |
Not applicable |
Male and Female
Inclusion criteria for each group shall be set as below.
Patients or individuals who meet all the criteria for the applicable group and provide consent to participate in the study or whose legally authorized representatives provide consent to participate in the study will be included.
[HAE type1/2 group]
1. Patients with symptoms due to angioedema
2. Patients with decreased C1-INH activity (50% or less)
3. Patients with a family history of HAE or a mutation of the C1-INH gene (SERPING1)
4. Patients aged 12 years or older when providing informed consent
[HAE type 3 group]
1. Patients who meet both a) and b) and were diagnosed HAE type 3
a) Have a history of recurrent angioedema without urticaria or the use of causative agents, have C1-INH activity in the range of 50% to 130%, and in whom antihistamines and steroids are ineffective for HAE attacks
b) Have a known HAE type 3 gene mutation on genetic testing or have a family history of angioedema
2. Patients aged 12 years or older when providing informed consent
[Healthy group]
1. Healthy volunteers
2. Individuals who do not have a disease (including HAE) of interest as the subject of the study
3. Individuals aged 12 years or older when providing informed consent
Exclusion criteria for each group shall be set as below. Patients/individuals who meet any of the criteria below for the relevant group will be excluded from the study.
[HAE type 1/2 group and HAE type 3 group]
1. Patients receiving C1-INH preparations for the 7 days prior to the time of blood collection
2. Patients receiving berotralstat hydrochloride for the 20 days prior to the time of blood collection
3. Patients receiving lanadelumab for the 70 days prior to the time of blood collection
4. Patients who are judged by the principal investigator or the subinvestigator to be inappropriate as study participants
[Healthy group]
1. Individuals who have been diagnosed with inflammatory diseases
2. Individuals who have been diagnosed with allergic diseases
3. Individuals who have not been administered a therapeutic drug continuously for 10 days or more within the 60 days* prior to the time of blood collection
4. Individuals who are judged by the principal investigator or the subinvestigator to be inappropriate as study participants
60
1st name | Kumiko |
Middle name | |
Last name | Hosono |
Takeda Pharmaceutical Company Limited
Japan Medical Office
103-8668
1-1, Nihonbashi-Honcho 2-chome, Chuo-ku, Tokyo, Japan
080-7172-0566
kumiko.hosono@takeda.com
1st name | Ritsuko |
Middle name | |
Last name | Nagasaka |
Takeda Pharmaceutical Company Limited
Japan Medical Office
103-8668
1-1, Nihonbashi-Honcho 2-chome, Chuo-ku, Tokyo, Japan
09014240921
ritsuko.nagasaka@takeda.com
Takeda Pharmaceutical Company Limited
None
Self funding
Kyushu University Institutional Review Board for Clinical Research
3-1-1, Maidashi, Higashi-ku,Fukuoka-shi,Fukuoka
092-642-6055
ijkseimei@jimu.kyushu-u.ac.jp
NO
NA
2021 | Year | 08 | Month | 06 | Day |
Unpublished
No longer recruiting
2021 | Year | 06 | Month | 15 | Day |
2021 | Year | 09 | Month | 28 | Day |
2021 | Year | 12 | Month | 07 | Day |
2022 | Year | 08 | Month | 31 | Day |
2022 | Year | 10 | Month | 14 | Day |
2024 | Year | 01 | Month | 31 | Day |
NA
2021 | Year | 06 | Month | 24 | Day |
2023 | Year | 12 | Month | 13 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050987
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