An expanded access record providing Lanadelumab 150 mg and Lanadelumab 300 mg in Hereditary Angioedema (HAE) and Angioedema, sponsored by Shire. No longer available at 20 sites in 5 countries. Open to participants aged 2 Years and older. Per ClinicalTrials.gov, last updated 2023-07-24.
Sponsored by Shire · Expanded access
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.
164 studies on the registry are indexed under Angioedema; 19 are open to participants now.
Browse Angioedema studies →Shire is the lead sponsor of 346 studies on the registry; 2 are open to participants now.
Of its 47 completed or terminated interventional studies of FDA-regulated products, 47 (100%) have results posted.
Counted across the registry records on this site, refreshed daily.
Inclusion Criteria:
TAK-743-6001 Study (Acute Attacks of HAE):
For Female participants of childbearing potential only:
TAK-743-5012 Study (Acute Attacks of Non-histaminergic Angioedema With Normal C1-Inhibitor (C1-INH)):
Female Participants of childbearing potential only:
Male Participants only:
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.
Also known as: TAK-743, SHP643, DX-2930
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.
Also known as: TAK-743, SHP643, DX-2930
Expanded access is arranged between your doctor and the company. Ask your care team to contact the provider listed on this record.
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