Development of diagnostic and disease-monitoring biomarkers of bradykinin-mediated angioedema with or without C1-inhibitor deficiency in hereditary angioedema - HAE BMA study

Takeda Pharmaceutical Company Limited0 sites60 target enrollmentAugust 6, 2021

Overview

No summary available.

Registry

who.int

Start Date

August 6, 2021

End Date

August 31, 2022

Last Updated

2 years ago

Study Type

Observational

Sex

All

Sponsor

•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