Expanded Access Program With Lanadelumab for Japanese People With Hereditary Angioedema
Status:
Recruiting
Trial end date:
2021-11-30
Target enrollment:
Participant gender:
Summary
The expanded access program allows people to gain access to an unlicensed treatment on
compassionate grounds. Lanadelumab, also known as TAK-743, is a medicine to help prevent
hereditary angioedema attacks. Lanadelumab is not yet licensed for use in Japan.
The main aim of this study is to allow Japanese teenagers and adults with type I or type II
hereditary angioedema to be treated with lanadelumab, through the expanded access program in
Japan.
Participants can either have taken part in the previous study SHP643-302 or can be new
participants. Participants just completing study SHP643-302 who reach the criteria can
automatically take part in this study. However, for new participants, the study doctor will
check who can take part at the first study visit.
For those who can take part, new participants will receive injections of lanadelumab just
under the skin. Eventually, after training, some of these will be able to inject themselves
with lanadelumab in the same way. Participants who injected themselves with lanadelumab in
study SHP643-302 can continue to do so during this study.
The study doctors will decide if each participant will be treated with lanadelumab every 2
weeks or every 4 weeks. Treatment with lanadelumab will continue until lanadelumab is
commercially available in Japan or the sponsor (Takeda) stops the study.
Participants can visit the clinic during treatment if needed. If treatment continues after 6
months, participants will visit the clinic every 12 weeks for a check-up. This will include
noting any hereditary angioedema attacks and side effects from the treatment. After 7 months
of treatment, the study staff will check-up with each participant every 2 weeks by telephone.
After treatment has finished, participants will visit the clinic for a final-check-up 4 weeks
later.