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Angioedema clinical trials

View clinical trials related to Angioedema.

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NCT ID: NCT02218294 Completed - Clinical trials for Hereditary Angioedema

Study to Determine How BCX4161 is Metabolized and Eliminated by the Body

Start date: August 2014
Phase: Phase 1
Study type: Interventional

The purpose of the study is to assess the extent that radioactive dose of BCX4161 taken by mouth ends up in the urine, feces and expired air. If there are metabolites of BCX4161 made by the body, the chemical composition of these metabolites and their profile over time in blood and urine will be determined.

NCT ID: NCT02159430 Not yet recruiting - Depression Clinical Trials

Hereditary AngioEdema, Neurobiology and Psychopathology

HAENP
Start date: November 2014
Phase: N/A
Study type: Observational [Patient Registry]

Since 1963 Hereditary AngioEdema (HAE) is considered an autosomal dominant disorder (Donaldson and Evans), characterized by a quantitative and/or qualitative deficit of C1 esterase inhibitor (C1-INH), which affects approximately 1:50.000 individuals in the general population. From this period the link between HAE and psychiatry was interrupted, however genetic issues could not comprehensively explain the clinical evolution of the disease. Clinical studies show an evident gap between genotype and phenotype of HAE. For this still controversial question, we have designed this cross-sectional study in order to establish the relationship between HAE clinical manifestations and neurobiological/psychopatological parameters.

NCT ID: NCT02125162 Completed - Clinical trials for Hereditary Angioedema

A Study of the Relative Bioavailability of a New Formulation of BCX4161 and the Effect of Food on BCX4161

Start date: April 2014
Phase: Phase 1
Study type: Interventional

The purpose of the study is to compare how the body takes up and then eliminates the study drug BCX4161 when it is taken orally as a hard gelatin capsule and as a soft gelatin capsule. This study will also evaluate whether food has any effect on how the body takes up BCX4161.

NCT ID: NCT02093923 Completed - Clinical trials for Hereditary Angioedema (HAE)

A Double-Blind, Multiple Ascending Dose Study to Assess Safety, Tolerability and Pharmacokinetics of DX-2930 in Hereditary Angioedema Participants

Start date: May 14, 2014
Phase: Phase 1
Study type: Interventional

The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics (PK) profile of multiple subcutaneous administrations of DX-2930 across a range of doses in HAE participants.

NCT ID: NCT02052141 Completed - Clinical trials for Hereditary Angioedema (HAE)

Safety and Efficacy Study of CINRYZE for Prevention of Angioedema Attacks in Children Ages 6-11 With Hereditary Angioedema

Start date: March 20, 2014
Phase: Phase 3
Study type: Interventional

Primary Objective - To assess the relative efficacy of two dose levels of CINRYZE (500 Units and 1000 Units) administered by intravenous (IV) injection every 3 or 4 days to prevent angioedema attacks in children 6 to 11 years of age with hereditary angioedema (HAE). Secondary Objectives - To assess the safety and tolerability, characterize the pharmacokinetics (PK) and pharmacodynamics (PD), and assess the immunogenicity of two dose levels of CINRYZE administered by IV injection in children 6 to 11 years of age with HAE.

NCT ID: NCT02045264 Completed - Clinical trials for Hereditary Angioedema (HAE)

Open-label, Single-arm Study to Assess the Pharmacokinetics, Safety, and Tolerability of a Single Subcutaneous Dose of Icatibant in Healthy Japanese Volunteers

Start date: February 21, 2014
Phase: Phase 1
Study type: Interventional

This is a single-dose study to evaluate the pharmacokinetics, safety, and tolerability of icatibant administered to adult Japanese subjects.

NCT ID: NCT01984788 Completed - Clinical trials for Hereditary Angioedema

Safety and Efficacy of Oral BCX4161 as a Prophylactic Treatment for HAE

OPuS-1
Start date: November 2013
Phase: Phase 2
Study type: Interventional

The purpose of this study is to determine whether BCX4161 given as a daily oral prophylactic treatment is safe and effective in reducing the number of acute attacks in patients with hereditary angioedema.

NCT ID: NCT01923207 Completed - Clinical trials for Hereditary Angioedema (HAE)

A Single Increasing Dose Study to Assess Safety and Tolerability of DX-2930 in Healthy Subjects

Start date: August 12, 2013
Phase: Phase 1
Study type: Interventional

The purpose of this study is to assess the safety and tolerability of the study drug (DX-2930) administered subcutaneously in healthy subjects. Subjects will be randomized to receive DX-2930 or placebo.

NCT ID: NCT01919801 Completed - Clinical trials for Angiotensin Converting Enzyme Inhibitor Induced Angioedema

Blinded Safety & Efficacy Placebo Controlled Study of Icatibant for Angiotensin Converting Enzyme Inhibitor Induced Angioedema

Start date: December 2, 2013
Phase: Phase 3
Study type: Interventional

This study is being conducted to compare the safety and efficacy of icatibant with placebo in the treatment for Angiotensin-Converting Enzyme Inhibitor (ACE-I)-Induced Angioedema in Adults.

NCT ID: NCT01912456 Completed - Clinical trials for Hereditary Angioedema Types I and II

A Study to Evaluate the Clinical Efficacy and Safety of Subcutaneously Administered C1-esterase Inhibitor in the Prevention of Hereditary Angioedema

Start date: January 2014
Phase: Phase 3
Study type: Interventional

The aim of this study is to assess the efficacy of C1-esterase inhibitor in preventing hereditary angioedema attacks when it is administered under the skin of subjects with hereditary angioedema. The safety of C1-esterase inhibitor will also be assessed. Each subject will enter a run-in period of up to 8-weeks. Subjects who complete the run-in period and who are eligible will then enter the treatment phase which comprises two sequential treatment periods. In the treatment phase, subjects will be randomized to one of four arms consisting of treatment with low- or higher-volume C1-esterase inhibitor in one treatment period and treatment with low- or higher-volume placebo in the other treatment period. The study will measure the number of hereditary angioedema attacks that subjects experience while receiving each treatment.