Official Title
Expanded Access Program: Lanadelumab for the Prevention of Acute Attacks of Hereditary Angioedema (HAE) in Pediatric Patients 2 to
Brief Summary

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]).

Detailed Description

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 .

Available
Individual Patients
Hereditary Angioedema (HAE)

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

Eligibility Criteria

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.

Eligibility Gender
All
Eligibility Age
Minimum: 2 Years~Maximum: 11 Years
Countries
Canada
Germany
Hungary
Spain
United States
Locations

AIRE Medical of Los Angeles
Santa Monica, California, 90404

Available

Investigator: Site Contact
Contact: 310-998-0060
Karen@airedoc.com

Investigator: Raffi Tachdjian, MD, MPH

Allergy & Asthma Clinical Research
Walnut Creek, California, 94598

Available

Investigator: Site Contact
Contact: 925-935-2599
awise@bayareaallergy.com

Investigator: Joshua Jacobs, MD

IMMUNOe Research Centers
Centennial, Colorado, 80112

Available

Investigator: Site Contact
Contact: 303-771-9000
mcollins@immunoe.com

Investigator: Isaac Melamed, MD

Institute Asthma and Allergy
Chevy Chase, Maryland, 20815

Available

Investigator: Site Contact
Contact: 301-986-0670
iaaresearchwan@gmail.com

Investigator: Henry Li, MD

Washington University School of Medicine
Saint Louis, Missouri, 63110

Available

Investigator: Site Contact
Contact: 314-996-8339
tmantia@wustl.edu

Investigator: James Wedner, MD

Hudson-Essex Allergy
Belleville, New Jersey, 07109

Available

Investigator: Site Contact
Contact: 973-759-5842
DScalcione@ProHEALTHcare.com

Investigator: Mark Weinstein, MD

Icahn School of Medicine at Mount Sinai
New York, New York, 10029

Available

Investigator: Site Contact
Contact: 212-241-0493
naushin.ali@mssm.edu

Investigator: Paula Busse, MD

Clinical Research Center of Charlotte
Charlotte, North Carolina, 28277

Available

Investigator: Site Contact
Contact: 980-999-2054

304 GGibson@crcharlotte.com

Investigator: Douglas Johnston, DO

Bernstein Clinical Research Center
Cincinnati, Ohio, 45231

Available

Investigator: Site Contact
Contact: 513-354-1750
CherylKB@bernsteincrc.com

Investigator: Jonathan Bernstein, MD

Toledo Institute of Clinical Research Asthma & Allergy Center
Toledo, Ohio, 43617

Available

Investigator: Site Contact
Contact: 419-843-8815
abbas.zaidi@ohmiallergy.com

Investigator: Syed Rehman, MD

AARA Research Center
Dallas, Texas, 75231

Available

Investigator: Site Contact
Contact: 214-365-0365
daguilar@aararesearch.com

Investigator: William Lumry, MD

Contacts

Shire Contact
+1 866 842 5335
ClinicalTransparency@shire.com

Shire
Takeda Development Center Americas, Inc.
NCT Number
MeSH Terms
Angioedema
Angioedemas, Hereditary
Intervention Name
Lanadelumab