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Expanded Access for the Prevention of Acute Attacks of Hereditary Angioedema (HAE) in Pediatric Participants Aged 2 to Less Than (<) 12 Years

IDENTIFIERS
Trial Protocol: TAK-743-6001
Clinicaltrials.gov: NCT04583007
PURPOSE

The primary purpose of this expanded access program is to evaluate clinical benefit, safety of lanadelumab in pediatric participants in the United States (US) with acute attacks of HAE who have completed the SHP643-301 (NCT04070326 [SPRING study]).

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Trial at a glance

What medical condition is being studied?   Hereditary Angioedema (HAE)
What is the trial testing?   Lanadelumab

Key requirements

Sex   
All
Age   
2 - 11 Years

Trial Details / Participation Requirements

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Trial Type:   Expanded Access
Trial Arms/Groups or Cohorts:   
:
Intervention:   Lanadelumab
Entry Criteria:
Inclusion Criteria: - 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: i) Participant has agreed to be abstinent or agreed to comply with the applicable contraceptive requirements of this protocol for the duration of the expanded access program and for 70 days after completion ii) Participant is not pregnant or breast-feeding Note: Participants who does not satisfy the above criteria will be excluded.

Trial Locations

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RESULTS
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Trial Protocol ID: TAK-743-6001
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