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| ID | Type | Description | Link |
|---|---|---|---|
| MACS-2020-081002 | Other Identifier | Takeda |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Participants With Hereditary Angioedema | Participants with HAE type I or type II who had initiated long-term prophylaxis (LTP) treatment with lanadelumab which was administered every two weeks (Q2W) or every four weeks (Q4W) or every six weeks (Q6W) or every eight weeks (Q8W) in accordance to Summary of Product Characteristics (SmPC), during a routine clinical setting will be followed up to 38 months. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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). | 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. | 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. | Up to Month 12 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Up to Month 12 |
| Percentage of Participants Who are Free of HAE Attacks Relative to Prior Treatment |
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Inclusion Criteria:
Exclusion Criteria:
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Adult or adolescent participants (aged greater than or equal to [>=] 12 years) with HAE type I or type II who initiated LTP treatment with lanadelumab within a routine clinical setting.
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| Name | Affiliation | Role |
|---|---|---|
| Study Director | Takeda | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| LKH-Universitätsklinikum Klinikum Graz | Graz | 8036 | Austria | |||
| Kepler Universitätsklinikum Linz |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39701274 | Derived | Magerl M, Bouillet L, Martinez-Saguer I, Gavini F, Bent-Ennakhil N, Sayegh L, Andresen I. Real-World Effectiveness of Lanadelumab in Hereditary Angioedema: Multicountry INTEGRATED Observational Study. J Allergy Clin Immunol Pract. 2025 Feb;13(2):378-387.e2. doi: 10.1016/j.jaip.2024.12.008. Epub 2024 Dec 17. |
| Label | URL |
|---|---|
| To obtain more information on the study, click here/on this link | View source |
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Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.
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IPD from eligible studies will be shared with qualified researchers according to the criteria and process described on https://vivli.org/ourmember/takeda/. For approved requests, the researchers will be provided access to anonymized data (to respect patient privacy in line with applicable laws and regulations) and with information necessary to address the research objectives under the terms of a data sharing agreement.
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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. |
| 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. | 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. | Up to Month 12 |
| Linz |
| 4021 |
| Austria |
| Medizinische Universitat Wien (Medical University of Vienna) | Vienna | 1090 | Austria |
| CHU de Grenoble | Grenoble | 38043 | France |
| CHRU Lille | Lille | 59800 | France |
| Groupement Hospitalier Edouard Herriot | Lyon | 69437 | France |
| CHU Montpellier - Hôpital St Eloi | Montpellier | 34295 | France |
| Hôtel Dieu de Paris Hospital | Paris | 75181 | France |
| Hôpital Saint Antoine | Paris | 75571 | France |
| Centre Hospitalier Universitaire Hopitaux de Rouen | Rouen | 76031 | France |
| Charitè Campus Mitte | Berlin | 10117 | Germany |
| Universitätsklinikum Frankfurt | Frankfurt am Main | 60596 | Germany |
| Medizinische Hochschule Hannover | Hanover | 30625 | Germany |
| Hämophilie Zentrum Rhein Main GmbH | Mörfelden-Walldorf | 64546 | Germany |
| Klinikum rechts der Isa der Technischen Universitaet Muenchen | Munich | 80802 | Germany |
| Universitatsklinikum Munster | Münster | 48149 | Germany |
| Universitätsklinikum Ulm | Ulm | 89075 | Germany |
| Navy Hospital of Athens | Athens | 115 21 | Greece |
| Laiko General Hospital of Athens | Athens | 115 27 | Greece |
| University General Hospital of Larissa | Larissa | 15125 | Greece |
| ID | Term |
|---|---|
| D054179 | Angioedemas, Hereditary |
| ID | Term |
|---|---|
| D000799 | Angioedema |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D000081208 | Hereditary Complement Deficiency Diseases |
| D000081207 | Primary Immunodeficiency Diseases |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D014581 | Urticaria |
| D017445 | Skin Diseases, Vascular |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
| D007153 | Immunologic Deficiency Syndromes |
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