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.
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
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.
Medical Research of Arizona
Scottsdale, Arizona, 85251
Investigator: Site Contact
Investigator: Michael Manning
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
Henry J. Kanarek- Allergy, Asthma & Immunology
Overland Park, Kansas, 66211
Investigator: Site Contact
Investigator: Henry Kanarek
Institute Asthma and Allergy
Chevy Chase, Maryland, 20815
Investigator: Site Contact
Contact: 301-986-0670
Investigator: Henry Li, MD
Institute For Asthma and Allergy
Chevy Chase, Maryland, 20815
Investigator: Site Contact
Investigator: Henry Li
University of Michigan Allergy and Immunology Specialty Clinic
Ann Arbor, Michigan, 48109-5008
Investigator: Site Contact
Investigator: Alan Baptist
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
Optimed Research, LTD
Columbus, Ohio, 43235
Investigator: Site Contact
Investigator: Donald McNeil
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
Takeda Contact
+1 866 842 5335
ClinicalTransparency@takeda.com