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| ID | Type | Description | Link |
|---|---|---|---|
| 2020-A01528-31 | Other Identifier | ID RCB |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Participants with Hereditary or Acquired Angioedema | Participants older than 18 years that are diagnosed with Hereditary or Acquired Angioedema and treated by lanadelumab. |
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| Measure | Description | Time Frame |
|---|---|---|
| Evaluation of the efficacy of the kallikrein inhibition by lanadelumab in patients with bradykinin-angioedema | Levels of cleaved HK measured by Western Blot | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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). |
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Inclusion Criteria:
Exclusion Criteria:
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Hereditary or Acquired Angiodema
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Federica Defendi, PhD | Contact | +330476765416 | fdefendi@chu-grenoble.fr | |
| Charlotte Kevorkian-Verguet | Contact | +330476765416 | ckevorkian-verguet@chu-grenoble.fr |
| Name | Affiliation | Role |
|---|---|---|
| Federica DEFENDI | Grenoble Alpes University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chu Grenoble Alpes | Recruiting | Grenoble | 38043 | France |
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| ID | Term |
|---|---|
| D000799 | Angioedema |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D014581 | Urticaria |
| D017445 | Skin Diseases, Vascular |
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Whole blood
| Day 7; 6, 12 and if possible 24 months |
| Immunogenicity of lanadelumab | Levels of antidrug antibodies in the sera of patients | Months 3, 6, 12 (and 24 if possible) |
| Evaluation of therapeutic escape | Increase/absence of decrease of the number of attacks during lanadelumab administration | Months 3, 6, 12 and if possible 24 |
| CHU Rouen | Recruiting | Rouen | France |
|
| D012871 |
| Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |