A Study of Lanadelumab in Teenagers and Adults With Hereditary Angioedema (HAE) in Argentina
Post Authorization Study to Monitor Efficacy, Effectiveness and Safety of Lanadelumab (Takhzyro®) in Patients Aged 12 Years and Older With Hereditary Angioedema (HAE) in Argentina
1 other identifier
observational
48
1 country
1
Brief Summary
The main aim of this study is to learn about the safety profile of lanadelumab in teenagers and adults with hereditary angioedema (HAE) in Argentina as part of routine routine practice. This study is about collecting data only. The study sponsor will not be involved in how participants are treated but will provide instructions on how the clinics will record what happens during the study. The study will collect data from the participant's medical records. Participants do not need to visit their doctor in addition to their normal visits.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Jul 2021
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 30, 2021
CompletedFirst Posted
Study publicly available on registry
July 9, 2021
CompletedStudy Start
First participant enrolled
July 28, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 7, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
August 7, 2023
CompletedOctober 4, 2023
October 1, 2023
2 years
June 30, 2021
October 3, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Percentage of Participants With Adverse Events of Special Interest (AESIs)
An adverse event (AE) is any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. Percentage of participants with AESIs such as hypersensitivity, immunogenicity, liver toxicity, and embryo-fetal toxicity will be reported.
Baseline up to end of study (up to 24 months)
Percentage of Participants With Serious and Non-serious Adverse Events (AEs)
An AE is any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. Serious AE is any untoward medical occurrence (whether considered to be related to study assigned treatment or not) that at any dose resulted in death, is life-threatening event, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, results in a congenital abnormality/birth defect, or was an important medical event. AEs including both serious and non-serious adverse events will be reported.
Baseline up to end of study (up to 24 months)
Secondary Outcomes (4)
Monthly Mean Rate of Investigator Confirmed HAE Attacks
At Weeks 12 and 24
Monthly Mean Rate of Investigator Confirmed Moderate or Severe HAE Attacks
At Weeks 12 and 24
Monthly Mean Rate of Investigator Confirmed HAE Attacks Requiring Acute Treatment
At Weeks 12 and 24
Percentage of Participants who are Attack Free
At Weeks 12 and 24
Study Arms (1)
All Participants
Participants with diagnosis of HAE who have received at least one dose of lanadelumab according to currently approved indications in routine clinical practice settings in Argentina will be observed in this study.
Eligibility Criteria
Study will include all participants treated with lanadelumab according to approved indications in routine clinical practice settings in Argentina.
You may qualify if:
- Participants (\>=12 years) with investigator confirmed diagnosis of HAE.
- Have received at least one dose of lanadelumab according to approved indications.
- Signed the mandatory consent that has been agreed with national regulatory authorities (ANMAT) as applicable.
You may not qualify if:
- \- Hypersensitivity to the active substance or to any of the excipients.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Takedalead
Study Sites (1)
Ic Projects Srl
Ciudad Autónoma de Buenos Aires, Buenos Aires, C1055ADD, Argentina
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Study Director
Takeda
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 30, 2021
First Posted
July 9, 2021
Study Start
July 28, 2021
Primary Completion
August 7, 2023
Study Completion
August 7, 2023
Last Updated
October 4, 2023
Record last verified: 2023-10
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF, CSR
- Access Criteria
- IPD from eligible studies will be shared with qualified researchers according to the criteria and process described on https://vivli.org/ourmember/takeda/. For approved requests, the researchers will be provided access to anonymized data (to respect patient privacy in line with applicable laws and regulations) and with information necessary to address the research objectives under the terms of a data sharing agreement.
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.