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

Available
Individual Patients
Hereditary Angioedema (HAE)
Angioedema

Drug: Lanadelumab 150 mg
TAK-743-6001: Participants will receive subcutaneous (SC) injection of lanadelumab at a dose of 150 milligrams (mg) at the same frequency (for every 2 weeks [Q2W] or for every 4 weeks [Q4W]) 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

Drug: Lanadelumab 300 mg
TAK-743-5012: Participants will receive SC injection of lanadelumab in prefilled syringe at a dose of 300 mg, Q2W or Q4W if well controlled for 26 weeks across Study TAK-743-3001 and this (TAK-743-5012) program.
Other Name: TAK-743
Other Name: SHP643
Other Name: DX-2930

Eligibility Criteria

Inclusion Criteria:

TAK-743-6001 Study (Acute Attacks of HAE): - 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: - 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; - Participant is not pregnant or breast-feeding

Note: Participants who do not satisfy the above criteria will be excluded.

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TAK-743-5012 Study (Acute Attacks of Non-histaminergic Angioedema With Normal C1-Inhibitor
(C1-INH)): - Participant has completed the treatment period of the TAK-743-3001 study (all Visit 14 assessments have been completed). - Participant is demonstrating continued benefit from lanadelumab treatment. - Participant and/or a parent(s)/legal guardian is informed of the nature of the expanded access program and can provide written informed consent for themselves or the child to participate (with assent from child when appropriate) prior to treatment). - Participant does not have any condition including lab test that in the opinion of the Investigator may compromise their safety. - Participant does not have a known hypersensitivity to lanadelumab or its components. - Participant and/or caregiver is willing to self-administer lanadelumab at home and has received documented training on self-administration during the Study TAK-743-3001 OR the participant and/or caregiver is willing to self-administer lanadelumab at home and will receive training at the first two dose administrations in accordance with protocol.

Female Participants of childbearing potential only: - 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 of the last dose. - Participant is not pregnant or breast-feeding.

Male Participants only: - Participant has agreed to comply with the applicable contraceptive requirements of this protocol for the duration of the expanded access program and for 70 days following the last dose of lanadelumab - Participant has agreed to not donate sperm during the course of the program and for 70 days following the last dose of lanadelumab.

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

Medical Research of Arizona
Scottsdale, Arizona, 85251

Available

Investigator: Site Contact
mm@medicalresearchaz.com

Investigator: Michael Manning

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

Henry J. Kanarek- Allergy, Asthma & Immunology
Overland Park, Kansas, 66211

Available

Investigator: Site Contact
drkanarek@kallergy.com

Investigator: Henry Kanarek

Institute Asthma and Allergy
Chevy Chase, Maryland, 20815

Available

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

Investigator: Henry Li, MD

Institute For Asthma and Allergy
Chevy Chase, Maryland, 20815

Available

Investigator: Site Contact
hl@allergyasthma.us

Investigator: Henry Li

University of Michigan Allergy and Immunology Specialty Clinic
Ann Arbor, Michigan, 48109-5008

Available

Investigator: Site Contact
abaptist@med.umich.edu

Investigator: Alan Baptist

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

Optimed Research, LTD
Columbus, Ohio, 43235

Available

Investigator: Site Contact
mcneil@optimed.us.com

Investigator: Donald McNeil

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

Takeda Contact
+1 866 842 5335
ClinicalTransparency@takeda.com

Shire
Takeda Development Center Americas, Inc.
NCT Number
MeSH Terms
Angioedema
Angioedemas, Hereditary
Antibodies, Monoclonal