Lanadelumab in Long-term Prophylaxis of Acquired Angioedema
ConditionAngioedema
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorBernstein Clinical Research Center
About this trial
use of lanadelumab in patients with acquired angioedema
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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)
Disqualifiers
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
Trial design
Design model
Single group
Treatments tested in this trial
Lanadelumab 300 mg
Biological/Vaccineno other intervention
Treatment groups
5 Participants
are divided into 1 treatment groupGroup A: open-label administrationOther 1 intervention
Trial outcomes
Primary outcomes
1
Primary Objective
Rate of investigator confirmed AAE attacks during study period, as measured by the ACT. AAE attack will be defined as a unique event during which the study subject will progress from no angioedema to symptoms of angioedema and no further angioedema for 24 hours after resolution of the event with rescu therapy
Time frame
12 monthsSponsors and contacts
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Source ClinicalTrials.gov