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NCT07251933
A Study of Lanadelumab in Children With Hereditary Angioedema (HAE) in Multiple Countries
Conditions: Hereditary Angioedema (HAE)
Sex: All
Ages: 2 Years – 11 Years
Healthy volunteers: No
Enrollment: 40
Sponsor: Takeda
Location: Hospital de Ninos Sor Maria Ludovica La Plata Buenos Aires
Summary
HAE is a rare condition. It causes sudden swelling under the skin and inside the body, like in the belly, throat, or genitals. This swelling happens because of a temporary leak in blood vessels but does not cause itching or hives. HAE is classified based on the amount of a protein in the blood called C1 inhibitor (C1-INH): HAE with normal C1-INH levels and HAE with limited or insufficient C1-INH levels (C1-INH deficiency). This study will concentrate on children with HAE C1-INH deficiency who have received Takhzyro (Lanadelumab) as prophylactic treatment.
The main goal of the study is to assess how well lanadelumab works in children with HAE-C1INH deficiency in everyday life. This will be measured by checking how long children who receive lanadelumab will be free of HAE attacks.
Other goals are to understand how children with HAE-C1INH deficiency are being treated with lanadelumab, how well the treatment works for them, how safe it is and how often these children need to use healthcare services (like doctor visits, hospital stays, etc.) because of their condition.
The study will only look at data already existing in the participants' medical records. No treatment will be given as part of the study.
Eligibility Criteria
Inclusion Criteria:
1. Participant is aged 2 to less than (\
Source: ClinicalTrials.gov (NCT07251933). StuddyBuddy aggregates publicly available trial information.