A Study of Lanadelumab in Teenagers and Adults With Hereditary Angioedema (HAE) in Argentina

Takeda

Status: Completed

Conditions: Angioedemas, Hereditary

Study type: Observational

Funder types: Industry

Identifiers

NCT04955964

TAK-743-4008

Details and patient eligibility

About

The main aim of this study is to learn about the safety profile of lanadelumab in teenagers and adults with hereditary angioedema (HAE) in Argentina as part of routine routine practice.

This study is about collecting data only. The study sponsor will not be involved in how participants are treated but will provide instructions on how the clinics will record what happens during the study. The study will collect data from the participant's medical records.

Participants do not need to visit their doctor in addition to their normal visits.

Enrollment: 48 patients

Sex: All

Ages: 12+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Participants (>=12 years) with investigator confirmed diagnosis of HAE.
• Have received at least one dose of lanadelumab according to approved indications.
• Signed the mandatory consent that has been agreed with national regulatory authorities (ANMAT) as applicable.

Exclusion criteria

• Hypersensitivity to the active substance or to any of the excipients.

Trial design

48 participants in 1 patient group

All Participants

Description:

Participants with diagnosis of HAE who have received at least one dose of lanadelumab according to currently approved indications in routine clinical practice settings in Argentina will be observed in this study.