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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

48 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-07-28

Study Completion Date

2023-08-07

Brief Summary

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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.

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Detailed Description

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Conditions

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Angioedemas, Hereditary

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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All Participants

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.

No interventions assigned to this group

Eligibility Criteria

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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.