Hereditary angioedema
Conditions
Interventions
None listed
Sponsors
Takeda Pharmaceutical Company Limited
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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)) | — |
Countries
Japan
Contacts
Public ContactRitsuko Nagasaka
Takeda Pharmaceutical Company Limited Japan Medical Office
Outcome results
None listed