- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04861090
A Study in Teenagers and Adults With Hereditary Angioedema (HAE) Type I or Type II Who Use Lanadelumab as Long-Term Prophylaxis (INTEGRATED)
Retrospective, Observational Chart Review Study Evaluating Clinical Effectiveness and Disease/Treatment Management Among Patients Who Initiated Long-term Prophylaxis With Takhzyro® in a Real-world Setting
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.
Study Overview
Status
Conditions
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
-
Graz, Austria, 8036
- LKH-Universitätsklinikum Klinikum Graz
-
Linz, Austria, 4021
- Kepler Universitatsklinikum Linz
-
Wien, Austria, 1090
- Medizinische Universitat Wien (Medical University of Vienna)
-
-
-
-
-
Grenoble, France, 38043
- CHU de Grenoble
-
Lille, France, 59800
- CHRU Lille
-
Lyon, France, 69437
- Groupement Hospitalier Edouard Herriot
-
Montpellier, France, 34295
- CHU Montpellier - Hôpital St Eloi
-
Paris, France, 75571
- Hôpital Saint Antoine
-
Paris, France, 75181
- Hôtel Dieu de Paris Hospital
-
Rouen, France, 76031
- Centre Hospitalier Universitaire Hôpitaux de Rouen
-
-
-
-
-
Berlin, Germany, 10117
- Charité Campus Mitte
-
Frankfurt am Main, Germany, 60596
- Universitatsklinikum Frankfurt
-
Hannover, Germany, 30625
- Medizinische Hochschule Hannover
-
Munich, Germany, 80802
- Klinikum rechts der Isa der Technischen Universitaet Muenchen
-
Mörfelden-Walldorf, Germany, 64546
- Hämophilie Zentrum Rhein Main GmbH
-
Münster, Germany, 48149
- Universitätsklinikum Münster
-
Ulm, Germany, 89075
- Universitätsklinikum Ulm
-
-
-
-
-
Athens, Greece, 115 27
- Laiko General Hospital of Athens
-
Athens, Greece, 115 21
- Navy Hospital of Athens
-
Larissa, Greece, 15125
- University General Hospital of Larissa
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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.
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Retrospective
Cohorts and Interventions
Group / Cohort |
---|
Participants With Hereditary Angioedema
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Percentage of Participants Who Are Free of Hereditary Angioedema (HAE) Attacks Treated With Lanadelumab
Time Frame: Up to Month 12
|
Percentage of participants who are free of HAE attacks will be reported.
A HAE attack is defined as the symptoms or signs consistent with an attack in at least 1 of the following locations: peripheral angioedema (cutaneous swelling involving an extremity, the face, neck, torso, and/or genitourinary region), abdominal angioedema (abdominal pain, with or without abdominal distention, nausea, vomiting, or diarrhea), laryngeal angioedema (stridor, dyspnea, difficulty speaking, difficulty swallowing, throat tightening, or swelling of the tongue, palate, uvula, or larynx).
|
Up to Month 12
|
Percentage of Participants Who Are Free of HAE Attacks Treated With Lanadelumab Administered Every Two Weeks
Time Frame: Up to Month 12
|
Percentage of participants who are free of HAE attacks treated with lanadelumab which was administered every two weeks will be reported.
|
Up to Month 12
|
Percentage of Participants Who Are Free of HAE Attacks Treated With Lanadelumab Administered Every Four Weeks
Time Frame: Up to Month 12
|
Percentage of participants who are free of HAE attacks treated with lanadelumab which was administered every four weeks will be reported.
|
Up to Month 12
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Percentage of Participants With Specific HAE Attack Occurrence
Time Frame: Up to Month 12
|
Percentage of participants with specific HAE attack occurrence (e.g.
attacks of specific localization, attacks requiring on-demand medication, life-threatening attacks) will be reported.
|
Up to Month 12
|
Percentage of Participants Who are Free of HAE Attacks Relative to Prior Treatment
Time Frame: Up to Month 12
|
Percentage of participants who are free of HAE attacks relative to prior treatment (e.g.
prior prophylaxis treatment or on-demand medications) among participants treated with lanadelumab will be reported.
|
Up to Month 12
|
Number of Participants Characterized With Every Four Weeks Adjustment
Time Frame: Every 4 weeks from start of treatment (Up to Month 12)
|
Number of participants will be characterized with every four weeks adjustment (e.g.
weight, age, duration of disease, history of life-threating attacks, length of attack-free interval during lanadelumab treatment) will be reported.
|
Every 4 weeks from start of treatment (Up to Month 12)
|
Number of Participants Characterized Based on Primary Reasons for Down Titration
Time Frame: Up to Month 12
|
Number of participants will be characterized based on primary reasons for down titration will be reported.
|
Up to Month 12
|
Collaborators and Investigators
Sponsor
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Cardiovascular Diseases
- Vascular Diseases
- Skin Diseases
- Immunologic Deficiency Syndromes
- Immune System Diseases
- Hypersensitivity, Immediate
- Genetic Diseases, Inborn
- Skin Diseases, Vascular
- Hypersensitivity
- Urticaria
- Hereditary Complement Deficiency Diseases
- Primary Immunodeficiency Diseases
- Angioedema
- Angioedemas, Hereditary
Other Study ID Numbers
- TAK-743-4006
- MACS-2020-081002 (Other Identifier: Takeda)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- Study Protocol
- Statistical Analysis Plan (SAP)
- Informed Consent Form (ICF)
- Clinical Study Report (CSR)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Hereditary Angioedema (HAE)
-
CENTOGENE GmbH RostockCompletedHereditary Angioedema | Hereditary Angioedema Type I | Hereditary Angioedema Type II | C1 Esterase Inhibitor Deficiency | HAE | Angio Edema | C4 Deficiency | Hereditary Angioedema Type IIITurkey, Armenia, Georgia, India, Peru, Poland, Romania
-
TakedaNot yet recruitingHereditary Angioedema (HAE)
-
CSL BehringRecruitingHereditary Angioedema (HAE)United States, Israel
-
TakedaRecruitingHereditary Angioedema (HAE)United Kingdom
-
TakedaRecruitingHereditary Angioedema (HAE)Japan
-
TakedaRecruitingHereditary Angioedema (HAE)Poland
-
ShireTakeda Development Center Americas, Inc.RecruitingHereditary Angioedema (HAE)France, Austria, Australia, Spain, Czechia, Italy, United Kingdom, Germany, Israel, Ireland, Brazil, Denmark, Greece, Sweden
-
ShireTakeda Development Center Americas, Inc.CompletedHereditary Angioedema (HAE)Canada, United States, Puerto Rico
-
ShireCompletedHereditary Angioedema (HAE)United States, Jordan, Canada
-
ShireDyax Corp.CompletedHereditary Angioedema (HAE)United States, Canada, Germany, Italy, Jordan, Puerto Rico, United Kingdom