A Study of Lanadelumab in Persons With Hereditary Angioedema (HAE) Type I or II (ENABLE)

Shire

Status: Completed

Conditions: Hereditary Angioedema (HAE)

Study type: Observational

Funder types: Industry

Identifiers

NCT04130191

TAK-743-402 (Other Identifier)

SHP643-402

Details and patient eligibility

About

The main aim of this study is to compare the number of HAE attacks occuring in persons using lanadelumab with the number of HAE attacks before lanadelumab treatment was started.

Data from participants who start the study after 1 March 2021, will be collected for 24 months; data from all other participants (who started the study before 1 March 2021) will be collected for 36 months. Participants will report information in a smartphone application at study start and for the next 3 months and then every 6 months until the study ends; data will also be collected by the study doctor during routine clinic visits

Enrollment: 140 patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

• Voluntarily provision of written, signed, and dated (personally or via a legally authorized representative) informed consent to participate in the study.
• Initiation of treatment with lanadelumab in accordance with current product labelling. Decision to start treatment with lanadelumab must be made before and be independent from enrollment in the study.
• Availability of information for HAE attack-related variables assessed at study enrollment for the previous three months.
• Ability to use a smartphone for data collection in this study.

Exclusion criteria

• Inability to provide written, signed, and dated informed consent.
• Participation in the study not considered appropriate by the treating physician/investigator.
• Contraindication to treatment with lanadelumab according to current product labelling.
• Pregnant or breastfeeding.
• Concomitant exposure to any investigational therapy (including medications not used for HAE).
• Current or planned participation in other interventional studies.

Trial design

140 participants in 1 patient group

Participants with hereditary angioedema (HAE)

Description:

Participants who initiate treatment with lanadelumab according to current product labelling will be enrolled and followed for up to 24 or 36 months (depending on their enrollment date).