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| ID | Type | Description | Link |
|---|---|---|---|
| TAK-743-5012 | Other Identifier | Takeda |
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| Name | Class |
|---|---|
| Takeda Development Center Americas, Inc. | INDUSTRY |
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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lanadelumab 150 mg | Drug | 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. |
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| Lanadelumab 300 mg | Drug | 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. |
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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:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medical Research of Arizona | Scottsdale | Arizona | 85251 | United States | ||
| AIRE Medical of Los Angeles |
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| Label | URL |
|---|---|
| To obtain more information on the study, click here/on this link | View source |
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| Santa Monica |
| California |
| 90404 |
| United States |
| Allergy & Asthma Clinical Research | Walnut Creek | California | 94598 | United States |
| Henry J. Kanarek- Allergy, Asthma & Immunology | Overland Park | Kansas | 66211 | United States |
| Institute Asthma and Allergy | Chevy Chase | Maryland | 20815 | United States |
| Institute For Asthma and Allergy | Chevy Chase | Maryland | 20815 | United States |
| University of Michigan Allergy and Immunology Specialty Clinic | Ann Arbor | Michigan | 48109-5008 | United States |
| Hudson-Essex Allergy | Belleville | New Jersey | 07109 | United States |
| Icahn School of Medicine at Mount Sinai | New York | New York | 10029 | United States |
| Clinical Research Center of Charlotte | Charlotte | North Carolina | 28277 | United States |
| Bernstein Clinical Research Center | Cincinnati | Ohio | 45231 | United States |
| Optimed Research, LTD | Columbus | Ohio | 43235 | United States |
| Toledo Institute of Clinical Research Asthma & Allergy Center | Toledo | Ohio | 43617 | United States |
| AARA Research Center | Dallas | Texas | 75231 | United States |
| Yang Medicine | Ottawa | Ontario | K1G6C6 | Canada |
| Charité - Universitätsmedizin Berlin. | Berlin | 10117 | Germany |
| Klinikum der Johann-Wolfgang Goethe-Universitat. | Frankfurt | 60590 | Germany |
| Hämophilie Zentrum Rhein Main GmbH | Mörfelden-Walldorf | 64546 | Germany |
| Semmelweis Egyetem. | Budapest | 1125 | Hungary |
| Hospital Universitario La Paz. Paseo de la Castellana | Madrid | 28046 | Spain |
| ID | Term |
|---|---|
| D054179 | Angioedemas, Hereditary |
| D000799 | Angioedema |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D000081208 | Hereditary Complement Deficiency Diseases |
| D000081207 | Primary Immunodeficiency Diseases |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D014581 | Urticaria |
| D017445 | Skin Diseases, Vascular |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
| D007153 | Immunologic Deficiency Syndromes |
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| ID | Term |
|---|---|
| C000596550 | lanadelumab |
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