Hereditary Angioedema (HAE) Clinical Trial
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)
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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| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
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Phase 3 | |
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| Recruiting |
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| Completed |
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Phase 3 | |
| Completed |
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EDEMA2: Evaluation of DX-88's Effect in Mitigating Angioedema
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Phase 2 | |
| Completed |
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FIRAZYR General Drug Use-Results Survey (Japan)
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| Recruiting |
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CSL312_3003 Safety and Pharmacokinetic Study in Subjects 2 to 11 Years of Age With Hereditary Angioedema
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Phase 3 | |
| Recruiting |
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| Completed |
NCT02741596 -
Long-term Safety and Efficacy Study of DX-2930 (SHP643) to Prevent Acute Angioedema Attacks in Patients With Type I and Type II HAE
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Phase 3 | |
| Completed |
NCT02093923 -
A Double-Blind, Multiple Ascending Dose Study to Assess Safety, Tolerability and Pharmacokinetics of DX-2930 in Hereditary Angioedema Participants
|
Phase 1 | |
| Completed |
NCT01541423 -
A European Post-Authorisation Observational Study Of Patients With Hereditary Angioedema
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| Completed |
NCT03845400 -
A Study of Lanadelumab in Persons With Hereditary Angioedema (HAE) Type I or II in North America
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| Completed |
NCT02586805 -
Efficacy and Safety Study of DX-2930 to Prevent Acute Angioedema Attacks in Patients With Type I and Type II HAE
|
Phase 3 | |
| Completed |
NCT02052141 -
Safety and Efficacy Study of CINRYZE for Prevention of Angioedema Attacks in Children Ages 6-11 With Hereditary Angioedema
|
Phase 3 | |
| Completed |
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A Study of Icatibant for Acute Attacks of Hereditary Angioedema in Japanese Participants
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Phase 3 | |
| Recruiting |
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A Study With Lanadelumab in Persons With Hereditary Angioedema (HAE) in Poland
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| Recruiting |
NCT05469789 -
A Study of Lanadelumab in Teenagers and Adults With Hereditary Angioedema (HAE)
|
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| Completed |
NCT05460325 -
A Study of Lanadelumab (SHP643) in Chinese Participants With Hereditary Angioedema (HAE)
|
Phase 3 | |
| Completed |
NCT01095510 -
CINRYZE for the Treatment of Hereditary Angioedema Attacks in Children Under the Age of 12
|
Phase 2 | |
| Recruiting |
NCT05578417 -
A Study to Review the Treatment and Outcomes of Teenagers and Adults With Non-histaminergic Angioedema With Normal C1 Inhibitor in Canada
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