A Study of Lanadelumab (Takhzyro) and Icatibant (Firazyr®) in Persons With HAE in China

Launched by TAKEDA · Mar 29, 2024

Keywords

ClinConnect Summary

This clinical trial is studying two medications, lanadelumab (Takhzyro) and icatibant (Firazyr), for people in China with Hereditary Angioedema (HAE), a condition that causes sudden swelling in various parts of the body. The main goals of the study are to find out how many HAE attacks occur in one month during treatment with lanadelumab and how quickly icatibant can help relieve these attacks. Researchers also want to learn more about any side effects from these treatments and gather information on how the medications are used in real-life settings.

To participate in this study, individuals must be Chinese and have received at least one dose of either lanadelumab or icatibant since December 2020. Participants will be treated by their doctors as usual, and the study will only review existing medical records to gather the needed information. This trial is open to people aged 12 and older, and it welcomes all genders. If you qualify and choose to join, you can expect to help researchers better understand these treatments while continuing your usual care.

Gender

ALL

Eligibility criteria

• Inclusion criteria:
• • Chinese participants who have received at least one dose of lanadelumab or icatibant from the lanadelumab NMPA approval date (02-Dec-2020) to the date of the day before the 1st site initiation date.
• • Informed consent will be obtained from the participant (and/or a legally authorized representative) prior to including that participant as a study participant and accessing that participant's data, except for cases in which the informed consent can be waived by the site.
• Exclusion criteria:
• • • Participation in other interventional studies involving lanadelumab, icatibant, or any other HAE drug or investigational product on or after the date of the participant's lanadelumab or icatibant initiation.