Expanded Access for the Prevention of Acute Attacks of 1) Hereditary Angioedema (HAE) in Children and 2) Non-histaminergic Angioedema With Normal C1-Inhibitor (C1-INH) in Teenagers and Adults
Public ClinicalTrials.gov record NCT04583007. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
Expanded Access Program: Lanadelumab for the Prevention of Acute Attacks of Hereditary Angioedema (HAE) in Pediatric Patients 2 to <12 Years of Age and Lanadelumab for the Prevention Against Acute Attacks of Non-histaminergic Angioedema With Normal C1-Inhibitor (C1-INH)
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT04583007
- Recruitment status
- No Longer Available
- Study type
- Expanded access
- Phase
- Not listed
- Enrollment
- Not listed
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 2 Years and older
- Sex
- All
- Healthy volunteers
- Not listed
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Not listed
- Primary completion
- Not listed
- Completion
- Not listed
- Last update posted
- Jul 24, 2023
United States locations
- U.S. sites
- 14
- U.S. states
- 10
- U.S. cities
- 13
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Medical Research of Arizona | Scottsdale | Arizona | 85251 | — |
| AIRE Medical of Los Angeles | Santa Monica | California | 90404 | — |
| Allergy & Asthma Clinical Research | Walnut Creek | California | 94598 | — |
| Henry J. Kanarek- Allergy, Asthma & Immunology | Overland Park | Kansas | 66211 | — |
| Institute Asthma and Allergy | Chevy Chase | Maryland | 20815 | — |
| Institute For Asthma and Allergy | Chevy Chase | Maryland | 20815 | — |
| University of Michigan Allergy and Immunology Specialty Clinic | Ann Arbor | Michigan | 48109-5008 | — |
| Hudson-Essex Allergy | Belleville | New Jersey | 07109 | — |
| Icahn School of Medicine at Mount Sinai | New York | New York | 10029 | — |
| Clinical Research Center of Charlotte | Charlotte | North Carolina | 28277 | — |
| Bernstein Clinical Research Center | Cincinnati | Ohio | 45231 | — |
| Optimed Research, LTD | Columbus | Ohio | 43235 | — |
| Toledo Institute of Clinical Research Asthma & Allergy Center | Toledo | Ohio | 43617 | — |
| AARA Research Center | Dallas | Texas | 75231 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 6 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT04583007, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jul 24, 2023 · Synced Oct 20, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT04583007 live on ClinicalTrials.gov.