Identification and Characterization of Genetic Variants in Hereditary Angioedema
Hereditary Angioedema With C1 Esterase Inhibitor DeficiencyThis project aims to analyse in an unbiased way the existence of genetic variants that contribute to explaining and predicting the differences in clinical expression between patients with HAE.
Safety and Pharmacokinetics of GNR-038 in Healthy Volunteers
Hereditary AngioedemaIt is an open-label dose-escalating study in sequential cohorts to assess safety and pharmacokinetics of GNR-038.
Pharmacokinetics of C1 Esterase Inhibitor in Hereditary Angioedema Subjects
Hereditary AngioedemaThe study objective was to describe the pharmacokinetics (PK) of one or two doses of C1 esterase inhibitor (C1INH-nf) in hereditary angioedema (HAE) subjects who were not experiencing an HAE attack.
A Study to Evaluate the Safety and Pharmacology of Subcutaneous Administration of CINRYZE With Recombinant...
Hereditary AngioedemaThe objectives of the study are to: Evaluate the safety and tolerability of subcutaneously administered CINRYZE with recombinant human hyaluronidase (rHuPH20) in subjects with hereditary angioedema (HAE) who previously participated in CINRYZE Study 0624-200 (NCT01095497) Characterize the pharmacokinetics and pharmacodynamics of subcutaneously administered CINRYZE with rHuPH20 Assess the immunogenicity of CINRYZE following subcutaneous (SC) administration of CINRYZE with rHuPH20
A Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of Subcutaneous CINRYZE Administration...
Hereditary AngioedemaThe objectives of the study are to: Evaluate the safety and tolerability of CINRYZE administered by subcutaneous injection in subjects with hereditary angioedema Characterize the pharmacokinetics and pharmacodynamics of CINRYZE administered by subcutaneous injection Assess the immunogenicity of CINRYZE following subcutaneous administration
Berinert P Study of Subcutaneous Versus Intravenous Administration
Hereditary AngioedemaThe study is performed to investigate the subcutaneous (s.c.) versus intravenous (i.v.) administration of Berinert P in patients with hereditary angioedema (HAE) to establish a second administration mode in cases where i.v. access is not suitable. The study is planned as a single centre, randomized, open-label, cross-over pharmacokinetic study. Subjects will either start with s.c. or i.v. pasteurised C1-Inhibitor concentrate (Berinert P) and than switch to the treatment not administered before.
Hereditary Angioedema Kininogen Assay
Hereditary AngioedemaA 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
A Study to Evaluate the Clinical Pharmacology and Safety of C1-esterase Inhibitor Administered by...
Hereditary Angioedema Types I and IIThe aim of the study is to assess what happens to C1-esterase inhibitor that is administered under the skin of subjects with hereditary angioedema. Three different dosing regimens of C1-esterase inhibitor will be assessed. Each subject will be assigned to receive 2 of the 3 dosing regimens, each for 4 weeks. The activity and concentration of C1-esterase inhibitor in the blood will be measured during each 4-week period. The study will also examine how well C1-esterase inhibitor administered under the skin is tolerated by the subjects.
Biomarker for Hereditary AngioEdema Disease
C1 Esterase Inhibitor DeficiencyAngio Edema6 moreInternational, multicenter, observational, longitudinal monitoring study to identify, validate and/or monitor Mass Spectrometry (MS)-based biomarker/s for Hereditary Angioedeme (HAE) disease and to test the clinical robustness, specificity, and predictive value of theese biomarker/s
Patient Registry Study of Berinert® in Normal Clinical Practice
Includes: Hereditary AngioedemaThe objective of this patient registry is to collect data on the safety of Berinert® in normal clinical practice in the United States. The patient registry will be maintained for a period of at least 3 years. The duration of individual patient participation will vary and is determined by the frequency of hereditary angioedema (HAE) attacks and the patient's need for Berinert® treatment.