An observational study in Angioedema, sponsored by University Hospital, Grenoble. Recruiting at 2 sites in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-03-19.
Sponsored by University Hospital, Grenoble · Observational
A multicenter observational study aiming to evaluate the efficacy of kallikrein inhibition by lanadelumab in patients with bradykinin- angioedema
The bradykinin-angioedema (AE-BK) is characterized by recurrent and unpredictable episodes of swelling; it can be disabling and disfiguring and the attacks affecting the larynx can be life-threatening.
The clinical symptoms depend on accumulation of bradykinin (BK), a vasoactive peptide responsible for vasodilation and increase of vascular leakage. BK formation depends on activation of the kallikrein-kinin cascade leading to uncontrolled generation of plasma kallikrein and subsequent proteolysis of high molecular-weight kininogen (HK).
Lanadelumab is a fully human monoclonal antibody inhibitor of plasma kallikrein, thereby preventing BK production; it represents an attractive therapeutic strategy for BK-AE prophylaxis.
The aim of this study is to evaluate the kallikrein inhibition by assessing the levels of cleaved HK and the immunogenicity of the lanadelumab.
69 studies on the registry are indexed under Angioedema; 16 are open to participants now.
This study's planned enrollment of 80 is below the median of 181 across 19 observational studies indexed under Angioedema.
Browse Angioedema studies →University Hospital, Grenoble is the lead sponsor of 837 studies on the registry; 207 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Hereditary or Acquired Angiodema
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants older than 18 years that are diagnosed with Hereditary or Acquired Angioedema and treated by lanadelumab.
Evaluation of the efficacy of the kallikrein inhibition by lanadelumab in patients with bradykinin-angioedema
Levels of cleaved HK measured by Western Blot
Time frame: 3 months
Evaluation of the efficacy of kallikrein inhibition by lanadelumab in patients with bradykinin-angioedema between T0 and the others visits
Levels of cleaved HK as measured by Western Blot Ratio Day 7/ Day 0, Ratio Month 6/ Day 0, Ratio Month 12/ Day (and if possible Month 24/ Day 0) of the levels of cleaved HK as measured by Western Blot - SE2: antidrug antibodies in the sera of patients at Months 3, 6, 12 (and if possible Month 24).
Time frame: Day 7; 6, 12 and if possible 24 months
Immunogenicity of lanadelumab
Levels of antidrug antibodies in the sera of patients
Time frame: Months 3, 6, 12 (and 24 if possible)
Evaluation of therapeutic escape
Increase/absence of decrease of the number of attacks during lanadelumab administration
Time frame: Months 3, 6, 12 and if possible 24
Plan to share: No
No publications or documents are linked to this record.
Started Sep 2020 (actual). Primary completion is estimated for Sep 2025, 60 months after the start.
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