Hereditary Angioedema Clinical Trial
Official title:
Hereditary Angioedema Kininogen Assay: A Multicenter, Epidemiological, Observational Study.
A multicenter epidemiological observational study aiming to explore the cleaved high-molecular weight kininogen (cHMWK) including identification and characterization of other metabolite/biomarkers in HAE type 1/2 patients
Hereditary angioedema (HAE) is a rare autosomal dominant genetic disorder characterized by recurrent tissue angioedema episodes, mainly caused by mutations in the SERPING1 gene that encodes C1 inhibitor (C1-INH), a protease involved in limiting bradykinin production. Low levels of C1-INH (HAE type 1) or dysfunctional C1-INH (HAE type 2) lead to bradykinin accumulation, resulting in capillary leakage and tissue swelling. High Molecular Weight Kininogen (HMWK) proteolysis, by active plasma kallikrein, results in bradykinin and cHMWK generation. The goal of this study is to explore the cHMWK concentrations in HAE type 1/2 patients, as a biomarker for this disease. The HAEKA study is performed in collaboration with Shire. Shire is a wholly owned subsidiary of Takeda Pharmaceutical Company Limited. ;
Status | Clinical Trial | Phase | |
---|---|---|---|
Enrolling by invitation |
NCT06007677 -
A Long-term Study of STAR-0215 in Participants With Hereditary Angioedema
|
Phase 2 | |
Completed |
NCT00997204 -
EASSI - Evaluation of the Safety of Self-Administration With Icatibant
|
Phase 3 | |
Completed |
NCT00438815 -
Open-Label C1 Esterase Inhibitor (C1INH-nf) for the Treatment of Acute Hereditary Angioedema (HAE) Attacks
|
Phase 3 | |
Completed |
NCT00748202 -
Berinert P Study of Subcutaneous Versus Intravenous Administration
|
Phase 3 | |
Completed |
NCT01426763 -
A Study to Evaluate the Safety and Pharmacology of Subcutaneous Administration of CINRYZE With Recombinant Human Hyaluronidase
|
Phase 2 | |
Completed |
NCT00432510 -
Pharmacokinetics of C1 Esterase Inhibitor in Hereditary Angioedema Subjects
|
Phase 1 | |
Completed |
NCT03712228 -
A Study to Investigate CSL312 in Subjects With Hereditary Angioedema (HAE)
|
Phase 2 | |
Active, not recruiting |
NCT05453968 -
Berotralstat Treatment in Children With Hereditary Angioedema
|
Phase 3 | |
Recruiting |
NCT05505916 -
An Open-label Extension Trial to Evaluate the Long-term Safety of KVD900 for On-Demand Treatment of Angioedema Attacks in Adolescent and Adult Patients With Hereditary Angioedema (HAE)
|
Phase 3 | |
Recruiting |
NCT05511922 -
PK Subtrial in Adolescent Patients With HAE Type I or II Participating in the KVD900-302 Trial
|
Phase 3 | |
Not yet recruiting |
NCT02159430 -
Hereditary AngioEdema, Neurobiology and Psychopathology
|
N/A | |
Completed |
NCT02303626 -
12-Week Safety and Efficacy Study of BCX4161 as an Oral Prophylaxis Against HAE Attacks
|
Phase 2/Phase 3 | |
Completed |
NCT01984788 -
Safety and Efficacy of Oral BCX4161 as a Prophylactic Treatment for HAE
|
Phase 2 | |
Completed |
NCT04888650 -
Assessment of the State of Health, Quality of Life and Expectations of Patients With Hereditary Angioedema
|
||
Completed |
NCT02448264 -
First-in-Human Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of BCX7353 in Healthy Western and Japanese Volunteers
|
Phase 1 | |
Completed |
NCT05118958 -
Phase 1 Crossover Study in Healthy Subjects to Evaluate the PK Profile of KVD824 Following Single and Multiple Doses of Modified Release (MR) Formulations
|
Phase 1 | |
Completed |
NCT06414252 -
Social Evaluated Cold Pressor Test in Hereditary Angioedema Patients
|
||
Active, not recruiting |
NCT04739059 -
Long-term Safety and Efficacy of CSL312 (Garadacimab) in the Prophylactic Treatment of Hereditary Angioedema Attacks
|
Phase 3 | |
Completed |
NCT02819102 -
An Open-label Drug-Drug Interaction Study to Evaluate the Effect of BCX7353 on Cytochrome P450 Enzyme Activity Using Probe Substrates
|
Phase 1 | |
Completed |
NCT01679912 -
A Call Center During HAE Attacks (SOS HAE)
|
Phase 4 |