Trial at a glance
What medical condition is being studied? Hereditary Angioedema (HAE)
Are placebos part of the trial? No
How many participants are being enrolled? 270
When is the trial being conducted? -
How long is participation in the trial? Participants will be enrolled in this observational study in sites in the United States and Canada as follows: 1. New lanadelumab users: a) participants who have not started lanadelumab at the time of enrollment already or b) already started lanadelumab prior to enrollment and have received <4 lanadelumab doses prior to enrollment date. 2. Prevalent lanadelumab users: participants who already started lanadelumab prior to enrollment and have received at least 4 lanadelumab doses prior to enrollment date. 3. New prophylaxis users: participants who are newly initiating HAE prophylaxis for the first time at enrollment (<4 prophylaxis HAE doses used prior to enrollment date).4. Prevalent prophylaxis users: participants who received at least 4 prophylaxis HAE doses prior to the enrollment date. Participants will be followed for 36 months after the enrollment date. Data from routine participant visits will be collected. Standardized patient-reported outcome (PRO) questionnaires will be collected from the participant via mobile phone application every 3 months. Additionally, participants will need to complete a participant HAE attack diary using the mobile phone application to self-report attacks at each time point an attack occurs.
Key requirements
Sex
All
Age
All
Accepts Healthy Volunteers?
No
Trial Details / Participation Requirements
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Trial Phase: N/A
Trial Type: Observational
Trial Arms/Groups or Cohorts:
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.
Primary Outcome Measure(s):
Number of Hereditary Angioedema (HAE) Attacks [Time Frame: From enrollment up to 36 months]
Secondary Outcome Measure(s):
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)]
Entry Criteria:
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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
RESULTS
Clinical Research Center of Alabama
504 Brookwood Blvd #250, Birmingham, AL 35209, USA
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Recruiting
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Medical Research of Arizona
7514 E Monterey Way, Scottsdale, AZ 85251, USA
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Recruiting
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AIRE Medical of Los Angeles
1301 20th St #380, Santa Monica, CA 90404, USA
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Recruiting
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Asthma and Allergy Associates, PC
2709 N Tejon St, Colorado Springs, CO 80907, USA
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Recruiting
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University of Kansas Medical Center Research Institute, Inc.
3901 Rainbow Blvd, Kansas City, KS 66160, USA
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Recruiting
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Institute for Asthma & Allergy - Chevy Chase
2 Wisconsin Cir #250, Chevy Chase, MD 20815, USA
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Recruiting
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Massachusetts General Hospital
55 Fruit St, Boston, MA 02114, USA
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Recruiting
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University of Michigan
500 S State St, Ann Arbor, MI 48109, USA
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Recruiting
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Washington University
4559 Scott Ave, St. Louis, MO 63110, USA
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Recruiting
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Jay M Kashkin, MD Allergy, Asthma and Immunology
23-00 NJ-208, Fair Lawn, NJ 07410, USA
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Recruiting
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The Mount Sinai Hospital
1468 Madison Ave, New York, NY 10029, USA
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Recruiting
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Clinical Research of Charlotte
8045 Providence Rd #300, Charlotte, NC 28277, USA
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Recruiting
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Portland Clinical Research/AAIM Care
8740 SE Sunnybrook Blvd, Clackamas, OR 97015, USA
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Recruiting
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AARA Research Center
10100 N Central Expy # 100, Dallas, TX 75231, USA
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Clinique Specialisée en Allergie de la Capitale
2600 Boulevard Laurier Bureau 880, Québec, QC G1V 4W1, Canada
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Recruiting
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Rafael H Zaragoza-Urdaz
317 Av. Ing. Manuel Domenech, San Juan, 00918, Puerto Rico
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Recruiting
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St. Michael's Hospital
30 Bond St, Toronto, ON M5B 1W8, Canada
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Will be Recruiting
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CHUM Hôtel-Dieu
3840 Rue Saint-Urbain, Montréal, QC H2W 1T8, Canada
Will be Recruiting
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University of California San Diego
9500 Gilman Dr, La Jolla, CA 92093, USA
Recruitment Complete
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Recruitment Complete
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University of South Florida Asthma, Allergy & Immunology
4503 N Armenia Ave, Tampa, FL 33603, USA
Recruitment Complete
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Riverside Medical Group, Belleville
5 S, Franklin Ave Suite 302, Belleville, NJ 07109, USA
Recruitment Complete
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Duke Asthma, Allergy & Airway Center
1821 Hillandale Rd Suite 25-A, Durham, NC 27705, USA
Recruitment Complete
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Bernstein Clinical Research Center, LLC
8444 Winton Rd, Cincinnati, OH 45231, USA
Recruitment Complete
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Penn State Univ. Milton S. Hershey Medical Center
700 HMC Cres Rd, Hershey, PA 17033, USA
Recruitment Complete
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University of Calgary - Heritage Medical Research Clinic
3310 Hospital Dr NW, Calgary, AB T2N 4N1, Canada
Recruitment Complete
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McMaster University Health Sciences Center
1200 Main St W, Hamilton, ON L8N 3Z5, Canada
Recruitment Complete
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Mid West Immunology Clinic
15700 37th Ave N STE 110, Plymouth, MN 55446, USA
Completed
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View all (28)
Trial Protocol ID: SHP643-403
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