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Angioedema clinical trials

View clinical trials related to Angioedema.

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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.

NCT ID: NCT01843530 Completed - Clinical trials for Acute ACE-induced Angioedema

Randomized, Double-blind, Two Arms, Multicenter, Phase III Study of Berinert for Treatment of ACE Induced Angioedema

Start date: November 2013
Phase: Phase 3
Study type: Interventional

This trial is a randomized, double-blind, two arms, multicenter, Phase III study of Berinert for treatment of ACE induced Angioedema. This study should show that Berinert shortens the time to complete resolution of signs and symptoms of acute ACE-induced angioedema of the upper airway tract compared to placebo when given on top of standard treatment. This study should also compare the time to onset of relief as defined by an at least one point reduction on the severity scale of ACE-induced angioedema with Berinert versus placebo.

NCT ID: NCT01826916 Completed - Clinical trials for Hereditary Angioedema (HAE)

EDEMA2: Evaluation of DX-88's Effect in Mitigating Angioedema

Start date: November 1, 2003
Phase: Phase 2
Study type: Interventional

EDEMA2 is an open-label, Phase 2 dose-ranging study designed to assess the safety and efficacy of repeated dosing of DX-88 (recombinant plasma kallikrein inhibitor) in Patients with Hereditary Angioedema.

NCT ID: NCT01760343 Completed - Clinical trials for Hereditary Angioedema Types I and II

A Study to Evaluate the Safety and Pharmacokinetics of Two Formulations of C1-esterase Inhibitor

Start date: January 2013
Phase: Phase 1
Study type: Interventional

A new formulation of Berinert (CSL830) is being investigated for the management of hereditary angioedema (HAE). The main aim of the study is to assess the safety of a single 1500 IU dose of the new formulation of Berinert. This study will also look at the pharmacokinetics of CSL830 relative to Berinert currently on the market.