A Study of Takhzyro in Teenagers and Adults With Hereditary Angioedema (HAE) in South Korea
ConditionHereditary Angioedema (HAE)
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age12+
SponsorTakeda
About this trial
Takhzyro is an approved treatment for hereditary angioedema (HAE) in South Korea. HAE is a rare condition which causes sudden swelling under the skin and inside the body, like in the belly, throat, or genitals. The main aim of this study is to check how safe Takhzyro is in teenagers and adults with HAE in everyday medical care in South Korea. Another aim is to see how well Takhzyro works in everyday medical care.
The treatment of participants and any check-ups will be determined by the treating doctors according to their normal practice. Participants may visit the study clinic several times during the study.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Participants aged 12 years or older at time of initiation of Takhzyro.
Participants who are treated or will be treated with Takhzyro according to the approved label of South Korea.
The participant or legally authorized representative agrees to participate.
Disqualifiers
Any of the contraindications included in the Prescribing Information (PI) for TAKHZYRO apply.
Participant is currently enrolled in an interventional trial.
Trial population
Participants diagnosed with HAE who are currently receiving Takhzyro or who initiate Takhzyro treatment for the first time.
Trial design
Design model
Cohort
Time perspective
Other
Treatments tested in this trial
No intervention
Other interventionThis is a non-interventional study.
Treatment groups
35 Participants
are divided into 1 treatment groupGroup A: All Participants1 intervention
Trial outcomes
Primary outcomes
1
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
An AE is any untoward medical occurrence in a study participant administered a medicinal product and which does not necessarily have to have a causal relationship with this treatment. SAE is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly; medically important events.
Time frame
Up to approximately 12 months2
Number of Participants With Expected and Unexpected AEs and SAEs
Unexpected AE is defined as AE that differs from the information in the product label in nature, severity, specificity, or outcome.
Time frame
Up to approximately 12 months3
Number of Participants With Adverse Drug Reactions (ADRs), Expected and Unexpected ADRs, Serious ADRs (SADRs), Expected and Unexpected SADRs
An ADR is an AE for which there is at least a reasonable suspicion of a causal relationship between an AE and a suspected medicinal product. Unexpected ADR is defined as an ADR that differs from the information in the ADR section of the product label in nature, severity, specificity, or outcome.
Time frame
Up to approximately 12 monthsSecondary outcomes
1
Number of HAE Attacks
Number of HAE attacks will be estimated across the pre- and post-treatment periods.
Time frame
Up to approximately 12 months2
Monthly HAE Attack Rate
Monthly HAE attack rate is defined as the number of HAE attacks collected from each study participant, adjusted to 28 days (1 month).
Time frame
Up to approximately 12 months3
Number of HAE Attacks Requiring Acute Treatment
Number of HAE attacks requiring acute treatment will be reported.
Time frame
Up to approximately 12 months4
Monthly HAE Attack Rate Requiring Acute Treatment
Monthly HAE attack rate requiring acute treatment will be reported.
Time frame
Up to approximately 12 monthsLocations
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: