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]).
This expanded access program enables the pediatric participants with a high unmet medical need to continue receiving lanadelumab during the interim period between completion of the SHP643-301 (NCT04070326 [SPRING study]) and Food and Drug Administration (FDA) review and potential approval in the age group (2 to <12 years) has been granted and when the product is commercially approved for this age group .
Drug: Lanadelumab
Participants will receive subcutaneous (SC) injection of lanadelumab at a dose of 150 milligrams (mg) at the same frequency (for every 2 weeks [q2wks] or for every 4 weeks [q4wks]) given at the completion of SPRING study until benefit-risk no longer favors the individual participant or an appropriate alternative therapy becomes available or lanadelumab 150 mg/ 1 milliliter (mL) becomes commercially available or the participants turns 12 years of age or participant chooses to discontinue treatment. For participants aged 6-12 years, a dose frequency may be modified based on a benefit-risk assessment and medical decision from the treating physician.
Other Name: TAK-743
Other Name: SHP643
Other Name: DX-2930
Inclusion Criteria: - Pediatric participants, 2 to )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.
AIRE Medical of Los Angeles
Santa Monica, California, 90404
Investigator: Site Contact
Contact: 310-998-0060
Investigator: Raffi Tachdjian, MD, MPH
Allergy & Asthma Clinical Research
Walnut Creek, California, 94598
Investigator: Site Contact
Contact: 925-935-2599
Investigator: Joshua Jacobs, MD
IMMUNOe Research Centers
Centennial, Colorado, 80112
Investigator: Site Contact
Contact: 303-771-9000
Investigator: Isaac Melamed, MD
Institute Asthma and Allergy
Chevy Chase, Maryland, 20815
Investigator: Site Contact
Contact: 301-986-0670
Investigator: Henry Li, MD
Washington University School of Medicine
Saint Louis, Missouri, 63110
Investigator: Site Contact
Contact: 314-996-8339
Investigator: James Wedner, MD
Hudson-Essex Allergy
Belleville, New Jersey, 07109
Investigator: Site Contact
Contact: 973-759-5842
Investigator: Mark Weinstein, MD
Icahn School of Medicine at Mount Sinai
New York, New York, 10029
Investigator: Site Contact
Contact: 212-241-0493
Investigator: Paula Busse, MD
Clinical Research Center of Charlotte
Charlotte, North Carolina, 28277
Investigator: Site Contact
Contact: 980-999-2054
Investigator: Douglas Johnston, DO
Bernstein Clinical Research Center
Cincinnati, Ohio, 45231
Investigator: Site Contact
Contact: 513-354-1750
Investigator: Jonathan Bernstein, MD
Toledo Institute of Clinical Research Asthma & Allergy Center
Toledo, Ohio, 43617
Investigator: Site Contact
Contact: 419-843-8815
Investigator: Syed Rehman, MD
AARA Research Center
Dallas, Texas, 75231
Investigator: Site Contact
Contact: 214-365-0365
Investigator: William Lumry, MD
Shire Contact
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