Hereditary Angioedema (HAE)EMPOWERNCT03845400
A Study of Lanadelumab in Persons With Hereditary Angioedema (HAE) Type I or II in North America
An observational study of Hereditary Angioedema (HAE), run by Shire at 29 sites in 3 countries.
Trial summary
The main aim of this study is to compare the HAE attack rate before and after lanadelumab treatment was started in persons with Hereditary Angioedeme Type I or II. Data from participants will be collected for at least 24 months. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Hereditary Angioedema (HAE)
- How many people
- 168 participants
- Where
- 29 sitesin 3 countries
- Study dates
- 30 Mar 2019to 22 Oct 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Participants with a diagnosis of Type I or Type II HAE.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
29 sites in 3 countries.
29 sites in 3 countries
United States23 sites
University of Michigan
Ann Arbor, Michigan, 48106
Riverside Medical Group, Belleville
Belleville, New Jersey, 07109
Clinical Research Center of Alabama
Birmingham, Alabama, 35209
Massachusetts General Hospital
Boston, Massachusetts, 02114-2752
Clinical Research of Charlotte
Charlotte, North Carolina, 28277
Institute for Asthma & Allergy - Chevy Chase
Chevy Chase, Maryland, 20815
Bernstein Clinical Research Center, LLC
Cincinnati, Ohio, 45231
Asthma and Allergy Associates, PC
Colorado Springs, Colorado, 80907
AARA Research Center
Dallas, Texas, 75231
Duke Asthma, Allergy & Airway Center
Durham, North Carolina, 27704
Jay M Kashkin, MD Allergy, Asthma and Immunology
Fair Lawn, New Jersey, 07410
Portland Clinical Research/AAIM Care
Happy Valley, Oregon, 97086
Penn State Hershey Medical Center
Hershey, Pennsylvania, 17033
University of Kansas Medical Center Research Institute, Inc.
Kansas City, Kansas, 66160
Yale University School of Medicine
New Haven, Connecticut, 06519
Mount Sinai
New York, New York, 10029
Mid West Immunology Clinic
Plymouth, Minnesota, 55446
University of California San Diego
San Diego, California, 92122
AIRE Medical of Los Angeles
Santa Monica, California, 90404
Medical Research of Arizona
Scottsdale, Arizona, 85248
Seattle Allergy & Asthma Research Institute
Seattle, Washington, 98115
Washington University
St Louis, Missouri, 63141
University of South Florida Asthma, Allergy & Immunology
Tampa, Florida, 33613
Canada5 sites
University of Calgary - Heritage Medical Research Clinic
Calgary, Alberta, T2N 2T9
McMaster University Health Sciences Center
Hamilton, Ontario, L8S 4K1
CHUM Hôtel-Dieu
Montreal, Quebec, H2X 0A9
Clinique Specialisée en Allergie de la Capitale
Québec, G1V 4W2
St. Michael's Hospital
Toronto, Ontario, M5B 1W8
About this study
Official title: An Observational, Non-interventional, Study of Patients With Hereditary Angioedema in the United States and Canada (EMPOWER Study)
The main aim of this study is to compare the HAE attack rate before and after lanadelumab treatment was started in persons with Hereditary Angioedeme Type I or II.
Data from participants will be collected for at least 24 months. Participants will report information in a smartphone application at study start and then every 3 months until the study ends; data will also be collected by the study doctor during routine clinic visits.
- Conditions
- Hereditary Angioedema (HAE)
- Medical subject headings
- Angioedemas, Hereditary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Type I or Type II HAE Participants | Participants with Type I or Type II HAE will be followed for 24 or 36 months depending upon enrollment date. Data collection will cease at the end of follow-up period, at the time of withdrawal, lost to follow-up, or death whichever comes first. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Hereditary Angioedema (HAE) Attacks
Number of HAE attacks before and after lanadelumab initiation will be reported.
Measured: From enrollment up to 36 months
Secondary outcomes (14)
Dose of Lanadelumab Injections
Dose of lanadelumab injections used during the study will be reported.
Measured: From enrollment up to 36 months
Frequency of Lanadelumab Injections
Frequency of lanadelumab injections during the study will be reported.
Measured: From enrollment up to 36 months
Proportion of Injections Based on the Type of Administration of Lanadelumab
Proportion of injections based on the type of administration of lanadelumab (self, caregiver, health care provider [HCP], other) will be reported.
Measured: From enrollment up to 36 months
Time From Diagnosis to Lanadelumab Initiation
Time from diagnosis of HAE attack(s) to lanadelumab treatment initiation will be reported.
Measured: From enrollment up to 36 months
Proportion of Participants who Discontinue Lanadelumab
Discontinuation is defined as no documented lanadelumab use after at least 2 missing consecutive doses after the last date of injection, or documented as treatment discontinued by the physician. Proportion of participants who discontinue lanadelumab treatment will be reported.
Measured: From enrollment up to 36 months
Number of Lanadelumab Injections Before Discontinuation per Reason for Injection
Discontinuation is defined as no documented lanadelumab use after at least 2 missing consecutive doses after the last date of injection, or documented as treatment discontinued by the physician. Number of injections administered by participant before discontinuation per reason for injection will be reported.
Measured: From enrollment up to 36 months
Number of Hospitalizations due to Hereditary Angioedema (HAE) Attack(s)
Number of hospitalizations due to HAE attack(s) will be reported.
Measured: From enrollment up to 36 months
Number of Emergency Room (ER) Visits due to Hereditary Angioedema (HAE) Attack(s)
Number of emergency room (ER) visits due to HAE attack(s) will be reported.
Measured: From enrollment up to 36 months
Number of Physician Visits due to Hereditary Angioedema (HAE) Attack(s)
Number of physician visits due to HAE attack(s) will be reported.
Measured: From enrollment up to 36 months
Rescue Medications Taken at Time of Hereditary Angioedema (HAE) Attack(s)
Number, type of rescue medications taken by the participants at the time of HAE attack(s) per the type of administration (self, caregiver, HCP, other) will be reported.
Measured: From enrollment up to 36 months
Hereditary Angioedema (HAE) Attack Control Score Before and After Lanadelumab Initiation, as Measured by the Angioedema Control Test (AECT)
AECT is a questionnaire and not a validated patient-reported outcome (PRO). HAE control score is evaluated as frequency of answers [very often, often, sometimes, seldom, not at all] to the following questions at record closest to enrollment date): 1. In the last 3 months, how often have you had angioedema? 2. In the last 3 months, how much has your quality of life been affected by angioedema? 3. In the last 3 months, how much has the unpredictability of your angioedema bothered you? 4. In the last 3 months, how well has your angioedema been controlled by your therapy?
Measured: From enrollment up to 36 months (every 3 months)
Angioedema Quality of Life (AE-QoL) Score
The AE-QoL is developed to measure health-related quality of life (HRQoL) impairment in participants with recurrent angioedema. It is a self-administered PRO designed for adults aged 18 years and older with a recall period of 4 weeks. There are 17 items across 4 domains: functioning (4 items), fatigue/mood (5 items), fears/shame (6 items), and food (2 items). Responses use a 5-point Likert scale ranging from 'never' to 'very often.' Global scores range from 0 to 100 and scores by domains range from 0 to 100.
Measured: From enrollment up to 36 months (every 3 months)
Work Productivity and Activity Impairment: General Health (WPAI:GH) Score
The WPAI:GH is a generic questionnaire to measure the effect of general health and symptom severity on work productivity and regular activities during the past 7 days. It can be self- or interviewer-administered to adults aged 18 years or older. This 6-item PRO covers work (5 items) and daily activities (1 item) using yes/no or numerical answers (number of hours). WPAI:GH outcomes are expressed as impairment percentages. An overall work productivity score (health or symptom) [%0WP], is calculated by multiplying the percentage of work time spent working (health or symptom) [% WTW] by the percentage productivity at work (health or symptom) [%PW]: %0WP = %WTW * %PW.
Measured: From enrollment up to 36 months (every 3 months)
Treatment Satisfaction (TSQM-9) Score
The TSQM is a generic questionnaire to measure participants' satisfaction with medication using yes/no and 5- or 7- point Likert scale response options. It is a self-administered PRO designed for adults aged 18 years or older with a recall period of 2 to 3 weeks, or since the last medication use. Version TSQM-9 includes 3 domains: effectiveness (3 items), convenience (3 items), and global satisfaction scale (3 items). Scores range from 0 to 100.
Measured: From enrollment up to 36 months (every 3 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2019
- Study start30 Mar 2019
- Primary completion22 Oct 2022
- Study completion22 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Hereditary Angioedema (HAE)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 168 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shire
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Takeda Development Center Americas, Inc.
- Responsible party
- Sponsor
- Investigators
- Study Director, Study director, Shire
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03845400
- Sponsor's protocol ID
- SHP643-403
- Other IDs
- TAK-743-403
- Acronym
- EMPOWER
- Status last verified
- Mar 2023
- First submitted
- 18 Feb 2019
- Last updated
- 30 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.
Publications
Zaragoza-Urdaz RH, Busse PJ, Fox D, Castaner DN, Khutoryansky N, Juethner S, McBayne T. Lanadelumab's Enduring Effectiveness and Safety in the Management of Hereditary Angioedema for Patients from Puerto Rico: Data from EMPOWER. Int Arch Allergy Immunol. 2026 Mar 12:1-11. doi: 10.1159/000550883. Online ahead of print.
PubMed 41818404Betschel SD, Chapdelaine H, Gagnon R, Goodyear MD, Keith PK, El-Zoeiby A, Khutoryansky N, Castaner DN. Long-term effectiveness and safety of lanadelumab in Canadian patients with hereditary angioedema: a subanalysis of the EMPOWER study. Allergy Asthma Clin Immunol. 2026 Jan 21;22(1):11. doi: 10.1186/s13223-025-01007-9.
PubMed 41566486Zanichelli A, Wuillemin WA, Aygoren-Pursun E, Banerji A, Busse PJ, Betschel SD, Cancian M, Gagnon R, Goodyear MD, Kinaciyan T, Kessel A, Magerl M, Recke A, Wedner HJ, Estepan DN, Watt M, Andresen I, Juethner S, Khutoryansky N, Martinez-Saguer I. Lanadelumab's impact on hereditary angioedema control and quality of life across disease activity subgroups: Real-world evidence. Ann Allergy Asthma Immunol. 2025 Nov;135(5):560-569.e2. doi: 10.1016/j.anai.2025.07.025. Epub 2025 Sep 6.
PubMed 40769455Bernstein JA, Betschel SD, Busse PJ, Banerji A, Wedner HJ, Manning M, Zaragoza-Urdaz RH, Anderson J, Gagnon R, Baptist AP, Soteres D, Lumry WR, Craig T, Petroni D, Hsu FI, Nova Estepan D, Juethner S, Watt M, Khutoryansky N, Zuraw BL; EMPOWER Investigators. Sustained Effectiveness, Tolerability, and Safety of Long-Term Prophylaxis with Lanadelumab in Hereditary Angioedema: The Prospective, Phase 4, Noninterventional EMPOWER Real-World Study. Adv Ther. 2025 Aug;42(8):3882-3901. doi: 10.1007/s12325-025-03226-3. Epub 2025 Jun 12.
PubMed 40504359Tachdjian R, Banerji A, Busse PJ, Agmon-Levin N, Anderson J, Cancian M, Spadaro G, Enciu C, Estepan DN, Khutoryansky N, Jain S, Recke A. Effective long-term prophylaxis with lanadelumab in adolescents with hereditary angioedema: EMPOWER/ENABLE. Pediatr Allergy Immunol. 2025 Apr;36(4):e70072. doi: 10.1111/pai.70072.
PubMed 40171989
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Observational, Non-interventional, Study of Patients With Hereditary Angioedema in the United States and Canada (EMPOWER Study)
- ClinicalTrials.gov ID
- NCT03845400
- Acronym / sponsor ID
- EMPOWER / SHP643-403
- Conditions
- Hereditary Angioedema (HAE)
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 168 participants (actual)
- Lead sponsor
- ShireIndustry (pharma, biotech, devices)
- Collaborators
- Takeda Development Center Americas, Inc.
- Study start
- 30 Mar 2019 (actual)
- Primary completion
- 22 Oct 2022 (actual)
- Study completion
- 22 Oct 2022 (actual)
- First posted
- 19 Feb 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The main aim of this study is to compare the HAE attack rate before and after lanadelumab treatment was started in persons with Hereditary Angioedeme Type I or II.
Data from participants will be collected for at least 24 months. Participants will report information in a smartphone application at study start and then every 3 months until the study ends; data will also be collected by the study doctor during routine clinic visits.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Type I or Type II HAE Participants | – | –Participants with Type I or Type II HAE will be followed for 24 or 36 months depending upon enrollment date. Data collection will cease at the end of follow-up period, at the time of withdrawal, lost to follow-up, or death whichever comes first. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Participants with a diagnosis of Type I or Type II HAE.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Number of Hereditary Angioedema (HAE) Attacks
Time frame: From enrollment up to 36 months
Number of HAE attacks before and after lanadelumab initiation will be reported.
14 secondary outcomes
Dose of Lanadelumab Injections
Time frame: From enrollment up to 36 months
Frequency of Lanadelumab Injections
Time frame: From enrollment up to 36 months
Proportion of Injections Based on the Type of Administration of Lanadelumab
Time frame: From enrollment up to 36 months
Time From Diagnosis to Lanadelumab Initiation
Time frame: From enrollment up to 36 months
Proportion of Participants who Discontinue Lanadelumab
Time frame: From enrollment up to 36 months
Number of Lanadelumab Injections Before Discontinuation per Reason for Injection
Time frame: From enrollment up to 36 months
Number of Hospitalizations due to Hereditary Angioedema (HAE) Attack(s)
Time frame: From enrollment up to 36 months
Number of Emergency Room (ER) Visits due to Hereditary Angioedema (HAE) Attack(s)
Time frame: From enrollment up to 36 months
Number of Physician Visits due to Hereditary Angioedema (HAE) Attack(s)
Time frame: From enrollment up to 36 months
Rescue Medications Taken at Time of Hereditary Angioedema (HAE) Attack(s)
Time frame: From enrollment up to 36 months
Hereditary Angioedema (HAE) Attack Control Score Before and After Lanadelumab Initiation, as Measured by the Angioedema Control Test (AECT)
Time frame: From enrollment up to 36 months (every 3 months)
Angioedema Quality of Life (AE-QoL) Score
Time frame: From enrollment up to 36 months (every 3 months)
Work Productivity and Activity Impairment: General Health (WPAI:GH) Score
Time frame: From enrollment up to 36 months (every 3 months)
Treatment Satisfaction (TSQM-9) Score
Time frame: From enrollment up to 36 months (every 3 months)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2023.
- Derived from this study: PubMed 41818404Zaragoza-Urdaz RH, Busse PJ, Fox D, Castaner DN, Khutoryansky N, Juethner S, McBayne T. Lanadelumab's Enduring Effectiveness and Safety in the Management of Hereditary Angioedema for Patients from Puerto Rico: Data from EMPOWER. Int Arch Allergy Immunol. 2026 Mar 12:1-11. doi: 10.1159/000550883. Online ahead of print.
- Derived from this study: PubMed 41566486Betschel SD, Chapdelaine H, Gagnon R, Goodyear MD, Keith PK, El-Zoeiby A, Khutoryansky N, Castaner DN. Long-term effectiveness and safety of lanadelumab in Canadian patients with hereditary angioedema: a subanalysis of the EMPOWER study. Allergy Asthma Clin Immunol. 2026 Jan 21;22(1):11. doi: 10.1186/s13223-025-01007-9.
- Derived from this study: PubMed 40769455Zanichelli A, Wuillemin WA, Aygoren-Pursun E, Banerji A, Busse PJ, Betschel SD, Cancian M, Gagnon R, Goodyear MD, Kinaciyan T, Kessel A, Magerl M, Recke A, Wedner HJ, Estepan DN, Watt M, Andresen I, Juethner S, Khutoryansky N, Martinez-Saguer I. Lanadelumab's impact on hereditary angioedema control and quality of life across disease activity subgroups: Real-world evidence. Ann Allergy Asthma Immunol. 2025 Nov;135(5):560-569.e2. doi: 10.1016/j.anai.2025.07.025. Epub 2025 Sep 6.
- Derived from this study: PubMed 40504359Bernstein JA, Betschel SD, Busse PJ, Banerji A, Wedner HJ, Manning M, Zaragoza-Urdaz RH, Anderson J, Gagnon R, Baptist AP, Soteres D, Lumry WR, Craig T, Petroni D, Hsu FI, Nova Estepan D, Juethner S, Watt M, Khutoryansky N, Zuraw BL; EMPOWER Investigators. Sustained Effectiveness, Tolerability, and Safety of Long-Term Prophylaxis with Lanadelumab in Hereditary Angioedema: The Prospective, Phase 4, Noninterventional EMPOWER Real-World Study. Adv Ther. 2025 Aug;42(8):3882-3901. doi: 10.1007/s12325-025-03226-3. Epub 2025 Jun 12.
- Derived from this study: PubMed 40171989Tachdjian R, Banerji A, Busse PJ, Agmon-Levin N, Anderson J, Cancian M, Spadaro G, Enciu C, Estepan DN, Khutoryansky N, Jain S, Recke A. Effective long-term prophylaxis with lanadelumab in adolescents with hereditary angioedema: EMPOWER/ENABLE. Pediatr Allergy Immunol. 2025 Apr;36(4):e70072. doi: 10.1111/pai.70072.
- To obtain more information on the study, click here/on this linkLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Study Director study director
Shire
29 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hereditary Angioedema (HAE), run by Shire at 29 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 29 sites in United States, Canada, Puerto Rico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Hereditary Angioedema (HAE) Attacks (time frame: From enrollment up to 36 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03845400, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Mar 2023.