Development of diagnostic and disease-monitoring biomarkers of bradykinin-mediated angioedema with or without C1-inhibitor deficiency in hereditary angioedema
- Conditions
- Hereditary angioedema
- Registration Number
- JPRN-UMIN000044637
- Lead Sponsor
- Takeda Pharmaceutical Company Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up continuing
- Sex
- All
- Target Recruitment
- 60
Not provided
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
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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))
- Secondary Outcome Measures
Name Time Method