Expanded Access for the Prevention of Acute Attacks of 1) Hereditary Angioedema (HAE) in Childrenā¦ (NCT04583007) | Clinical Trial Compass
NO_LONGER_AVAILABLENot Applicable
Expanded Access for the Prevention of Acute Attacks of 1) Hereditary Angioedema (HAE) in Children and 2) Non-histaminergic Angioedema With Normal C1-Inhibitor (C1-INH) in Teenagers and Adults
United States
Plain-language summary
The expanded access program allows people to gain access to an unlicensed treatment on compassionate grounds. Lanadelumab, also known as TAK-743, is a medicine to help prevent angioedema attacks. This expanded access program enables these participants with a high unmet medical need to continue receiving lanadelumab during the interim period between completion of either the SHP643-301 (NCT04070326; SPRING study) or the TAK-743-3001 (NCT04444895) study and potential licensure of lanadelumab for the respective age group and/or treatment.
Who can participate
Age range2 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
TAK-743-6001 Study (Acute Attacks of HAE):
* Pediatric participants, 2 to \<12 years of age, with HAE who completed the SHP643-301 (SPRING) study and are deriving continued clinical benefit from lanadelumab treatment will be invited to take part in this program
* Participants have no suitable alternative treatment options and cannot enter a lanadelumab clinical trial
* Participant has a parent(s)/legal guardian who is informed of the nature of the expanded access program and can provide written informed consent for the child to participate (with assent from child when appropriate) prior to treatment
* Participants does not have any of the following liver function test abnormalities : alanine aminotransferase (ALT) greater than (\>)3x upper limit of normal (ULN), or aspartate aminotransferase (AST) \>3x ULN, or total bilirubin \>2x ULN (unless the bilirubin elevation is a result of Gilbert's syndrome)
* Participant does not have any condition that in the opinion of the Investigator may compromise their safety
* Participant does not have a known hypersensitivity to lanadelumab or its components
* Participant (greater than or equal to \>or=6 years) and/or caregiver is willing to self-administer lanadelumab at home and has received documented training on self-administration during the SHP643-301 (SPRING) Study
For Female participants of childbearing potential only:
* Participant has agreed to be abstinent or agreed to comply with the applicable contraceptiā¦