A Study in Teenagers and Adults With Hereditary Angioedema (HAE) Type I or Type II Who Use Lanadelumab as Long-Term Prophylaxis

Takeda207 enrolled

Overview

The main aims of this study are to learn how many people with HAE Type I or Type II are attack-free when treated with lanadelumab in real life. This includes the number of people that are attack-free when lanadelumab is given every 2 and every 4 weeks. This study is about collecting existing data only; participants will not receive lanadelumab as part of this study. No new information will be collected during this study. Only data already available at the participant's doctor's office will be reviewed and collected for this study. Participants do not need to visit their doctor in addition to their normal visits.

Study Type

OBSERVATIONAL

Enrollment

207

Conditions

Hereditary Angioedema (HAE)

Eligibility

Sex: ALLMin age: 12 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Participant is aged \>= 12 years at the time of the last documented HAE attack in the eligibility period. * Participant has a physician-confirmed diagnosis (or confirmation in medical records) of HAE type I or type II. * Participant had initiated LTP with lanadelumab during the eligibility period. * Participant provides informed consent or assent prior to the initiation of any study procedures (where required by local regulations). Exclusion Criteria: * Participant was enrolled in a therapeutic investigational drug or device trial during the observation period. * Participant without documented HAE attacks in the pre-index period and/or without available participant diary or systematic documentation of HAE attacks in the medical records during the post index period.

Locations (20)

LKH-Universitätsklinikum Klinikum Graz

Graz, Austria

Kepler Universitätsklinikum Linz

Linz, Austria

Medizinische Universitat Wien (Medical University of Vienna)

Vienna, Austria

CHU de Grenoble

Grenoble, France

CHRU Lille

Lille, France

Groupement Hospitalier Edouard Herriot

Lyon, France

CHU Montpellier - Hôpital St Eloi

Montpellier, France

Hôtel Dieu de Paris Hospital

Paris, France

Hôpital Saint Antoine

Paris, France

Centre Hospitalier Universitaire Hopitaux de Rouen

Rouen, France

...and 10 more locations

Outcomes

Primary Outcomes

Percentage of Participants Who Are Free of Hereditary Angioedema (HAE) Attacks Treated With Lanadelumab

Percentage of participants who are free of HAE attacks will be reported. A HAE attack is defined as the symptoms or signs consistent with an attack in at least 1 of the following locations: peripheral angioedema (cutaneous swelling involving an extremity, the face, neck, torso, and/or genitourinary region), abdominal angioedema (abdominal pain, with or without abdominal distention, nausea, vomiting, or diarrhea), laryngeal angioedema (stridor, dyspnea, difficulty speaking, difficulty swallowing, throat tightening, or swelling of the tongue, palate, uvula, or larynx).

Time frame: Up to Month 12

Percentage of Participants Who Are Free of HAE Attacks Treated With Lanadelumab Administered Every Two Weeks

Percentage of participants who are free of HAE attacks treated with lanadelumab which was administered every two weeks will be reported.

Time frame: Up to Month 12

Percentage of Participants Who Are Free of HAE Attacks Treated With Lanadelumab Administered Every Four Weeks

Percentage of participants who are free of HAE attacks treated with lanadelumab which was administered every four weeks will be reported.

Time frame: Up to Month 12

Secondary Outcomes

Percentage of Participants With Specific HAE Attack Occurrence

Percentage of participants with specific HAE attack occurrence (e.g. attacks of specific localization, attacks requiring on-demand medication, life-threatening attacks) will be reported.

Time frame: Up to Month 12

Percentage of Participants Who are Free of HAE Attacks Relative to Prior Treatment

Percentage of participants who are free of HAE attacks relative to prior treatment (e.g. prior prophylaxis treatment or on-demand medications) among participants treated with lanadelumab will be reported.

Time frame: Up to Month 12

Number of Participants Characterized With Every Four Weeks Adjustment

Number of participants will be characterized with every four weeks adjustment (e.g. weight, age, duration of disease, history of life-threating attacks, length of attack-free interval during lanadelumab treatment) will be reported.

Time frame: Every 4 weeks from start of treatment (Up to Month 12)

Number of Participants Characterized Based on Primary Reasons for Down Titration

Number of participants will be characterized based on primary reasons for down titration will be reported.

Time frame: Up to Month 12