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

Takeda

Status: Completed

Conditions: Hereditary Angioedema (HAE)

Study type: Observational

Funder types: Industry

Identifiers

NCT04861090

MACS-2020-081002 (Other Identifier)

TAK-743-4006

Details and patient eligibility

About

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.

Enrollment: 207 patients

Sex: All

Ages: 12+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

207 participants in 1 patient group

Participants With Hereditary Angioedema

Description:

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.