Recruiting NCT06818474
Lanadelumab in Long-term Prophylaxis of Acquired Angioedema
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Lanadelumab 300 mg.
- Who it may be relevant to
- Registry conditions: Angioedema. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
use of lanadelumab in patients with acquired angioedema
Interventions
- Biological Lanadelumab 300 mg
no other intervention
Primary outcome measures
- Primary Objective [Time frame: 12 months]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 1 center
- Bernstein Clinical Research Center, LLC — Cincinnati
Identifiers
NCT: NCT06818474 · Tak-02