A Study of Icatibant (TAK-667) in Japanese Children and Teenagers With Acute Attacks of Hereditary Angioedema
Status:
Completed
Trial end date:
2021-07-27
Target enrollment:
Participant gender:
Summary
The main aim of the study is to check for side effects from icatibant in children and
teenagers with hereditary angioedema (HAE). Other aims are to check how well icatibant
controls HAE symptoms in these children and teenagers, and how much icatibant stays in their
blood.
At the first visit, the study doctor will check if each child or teenager can take part. For
those who can take part, participants and their parents or caregivers will visit the clinic
or hospital when they have their next HAE attack. Participants will receive 1 injection
(shot) of icatibant in a vein and will stay at the clinic or hospital until their HAE
symptoms are under control. Participants can receive up to 2 more injections of icatibant
over time if their HAE symptoms don't improve or get worse.
After the participants go home, the study staff will follow up with them by a telephone call
1 to 2 days later. Then, the participants will visit the clinic or hospital 1 week after they
received the icatabant injection.
The participant can visit the clinic or hospital and be treated with icatibant in the same
way for up to 3 HAE attacks in total.