A Study With Lanadelumab in Persons With Hereditary Angioedema (HAE) in Poland
NCT ID: NCT05147181
Last Updated: 2025-07-03
Study Results
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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ACTIVE_NOT_RECRUITING
48 participants
OBSERVATIONAL
2022-03-11
2026-03-28
Brief Summary
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Participants will need to visit their doctor 5 times in total as part of this study. The visits are planned every 6 months. Participants will also be asked to fill out questionnaires as part of this study.
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Participants With HAE
Participants with type 1 or type 2 HAE when treated with lanadelumab in real life in accordance with Summary of Product Characteristics (SmPC) and NDP requirements will be observed in this prospective observational study for 36 months
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* In the opinion of the investigator, the participant is capable of understanding and complying with protocol requirements.
* The participant or, when applicable, the participant's legally acceptable representative signs and dates a written, informed consent form and any required privacy authorization prior to the initiation of any study procedures.
* HAE participant (aged greater than or equal to \[\>=\] 12 years old.) qualified to treatment with lanadelumab in the NDP and receiving treatment according to the Summary of Product Characteristics for Takhzyro.
* Male or female participants, aged \>=12 years old.
Exclusion Criteria
* Currently participates or plans to participate in any interventional clinical trial.
* Any other reason that, in the Investigator's opinion, makes the participant unsuitable to participate in this study.
Participants should be included in the study only once. Data erroneously collected from participants for which written consent is not available, will not be included in or will be deleted from the database.
12 Years
ALL
No
Sponsors
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Takeda
INDUSTRY
Responsible Party
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Principal Investigators
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Study Director
Role: STUDY_DIRECTOR
Takeda
Locations
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Wielkopolskie Centrum Pulmonologii i Torakochirurgii im. Eugenii i Janusza Zeylandów/Szpital w Poznaniu
Poznan, Greater Poland Voivodeship, Poland
Szpital Uniwersytecki nr 2
Bydgoszcz, Kuyavian-Pomeranian Voivodeship, Poland
Szpital Uniwersytecki w Krakowie
Krakow, Lesser Poland Voivodeship, Poland
Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego we Wrocławiu
Wroclaw, Lower Silesian Voivodeship, Poland
Wojewódzki Szpital Specjalistyczny im. Stefana Kardynała Wyszyńskiego
Lublin, Lublin Voivodeship, Poland
Wojskowy Instytut Medyczny
Warsaw, Masovian Voivodeship, Poland
Kliniczny Szpital Wojewódzki nr 1 im. Fryderyka Chopina w Rzeszowie
Rzeszów, Podkarpackie Voivodeship, Poland
Uniwersytecki Szpital Kliniczny w Białymstoku
Bialystok, Podlaskie Voivodeship, Poland
Uniwersytet Medyczny w Białymstoku
Bialystok, Podlaskie Voivodeship, Poland
Uniwersyteckie Centrum Kliniczne
Gdansk, Pomeranian Voivodeship, Poland
Samodzielny Publiczny Zespół Gruźlicy i Chorób Płuc w Olsztynie
Olsztyn, Warmian-Masurian Voivodeship, Poland
SPSK nr 2 PUM w Szczecinie
Szczecin, Zachodniopomorske, Poland
SAMODZIELNY PUBLICZNY ZAKŁAD OPIEKI ZDROWOTNEJ - Centralny Szpital Kliniczny Uniwersytety Medycznego w Łodzi
Lodz, Łódź Voivodeship, Poland
Szpital Powiatowy w Chmielniku
Chmielknik, Świętokrzyskie Voivodeship, Poland
Countries
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Related Links
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To obtain more information on the study, click here/on this link
Other Identifiers
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MACS-2020-081003
Identifier Type: OTHER
Identifier Source: secondary_id
TAK-743-4003
Identifier Type: -
Identifier Source: org_study_id
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