A Study With Lanadelumab in Persons With Hereditary Angioedema (HAE) in Poland (CHOPIN)

Takeda

Status: Active, not recruiting

Conditions: Hereditary Angioedema (HAE)

Study type: Observational

Funder types: Industry

Identifiers

NCT05147181

MACS-2020-081003 (Other Identifier)

TAK-743-4003

Details and patient eligibility

About

The main aim of this study is to learn about how many persons with HAE type I or type II are attack-free when treated with lanadelumab in real life, how many attacks occur and how many of these attacks need rescue treatment and about the nature of HAE attacks.

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.

Enrollment: 48 patients

Sex: All

Ages: 12+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria

Participant eligibility is determined according to the following criteria prior to entry into the study:

• 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

Any participant who meets any of the following criteria will not qualify for entry into the study:

• 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.

Trial design

48 participants in 1 patient group

Participants With HAE

Description:

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