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NCT06818474PHASE4Recruiting

Lanadelumab in Long-term Prophylaxis of Acquired Angioedema

Bernstein Clinical Research Center

Start Date

6/1/2024

Completion Date

12/1/2027

Summary

use of lanadelumab in patients with acquired angioedema

Eligibility Criteria

Age Range: 18 years to No maximum

Inclusion Criteria: * A diagnosis of AAE with recurrent attacks without urticaria (decreased C1INH functional, quantitative levels, decreased C4 and decreased C1q levels, no family history of angioedema), presence of anti-C1INH antibody and/or paraproteinemia (e.g. monoclonal gammopathy of unknown significance) * historical attack rate of \>= on attack per month prior to starting tranexamic acid (TAA) Exclusion Criteria: * History of anaphylaxis or hypersensitivity to biologics * History of major systemic disease not well controlled in opinion of the PI * Women who are pregnant or breast feeding * Concurrent participation in other clinical trials * HAE Type 1 or 2 and normal complement HAE

Interventions

BIOLOGICAL

Lanadelumab 300 mg

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Conditions

Angioedema

Locations

Bernstein Clinical Research Center, LLC

Cincinnati, Ohio 45236

United States