Study to Evaluate the Real-world Effectiveness of Lanadelumab in Participants With Hereditary Angioedema (HAE)
This observational, prospective study aims to evaluate the real-world effectiveness of lanadelumab in participants with hereditary angioedema (HAE). Participant-reported attack diaries and patient-reported outcomes (PROs) as well as physician assessments at standard of care (SoC) visits will be used to describe HAE attack rates, treatment patterns, healthcare utilization and participant quality of life.
- Hereditary Angioedema (HAE)
- Eligible Ages
- All ages
- Eligible Genders
- Accepts Healthy Volunteers
- Voluntarily provide written, signed, and dated (personally or via a legally-authorized representative) informed consent/and assent as applicable to participate in the study. Expression of understanding and agreement by fully informed parent(s) or legal guardian is required to permit the investigator to enroll a child in this study. The choice of the terms parental consent or parental permission in different regions may reflect local legal/regulatory and ethical considerations.
- Diagnosis of HAE Type I or Type II.
- Ability to use a mobile device for data collection in the study.
- Participation in any interventional clinical trial at the time of enrollment.
- Unable to provide written, signed, and dated informed consent/assent.
- Investigator believes that the participant is not a suitable candidate for the study.
- Study Type
- Observational Model
- Time Perspective
|Type I or Type II HAE Participants||Participants will be followed for 36 months after the enrollment date up to the time of withdrawal, lost to follow-up, death or end of follow-up (36 months) whichever comes first.|
Study ContactTakeda Development Center Americas Contact
+1 866 842 5335