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Hereditary Angioedema clinical trials

View clinical trials related to Hereditary Angioedema.

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NCT ID: NCT03697187 Completed - Clinical trials for Hereditary Angioedema

Patient Registry to Evaluate the Real-world Safety of Ruconest®

Start date: June 30, 2018
Phase:
Study type: Observational [Patient Registry]

This is a prospective, real-world, observational patient registry for patients with HAE who are receiving treatment with Ruconest for HAE.

NCT ID: NCT03485911 Completed - Clinical trials for Hereditary Angioedema

Efficacy and Safety Study of BCX7353 as an Oral Treatment for the Prevention of Attacks in HAE

APeX-2
Start date: February 6, 2018
Phase: Phase 3
Study type: Interventional

This is a phase 3, multicenter, randomized, double-blind, placebo-controlled trial to evaluate the efficacy and safety of oral BCX7353 in preventing acute angioedema attacks in patients with Type I and Type II HAE.

NCT ID: NCT03472040 Completed - Clinical trials for Hereditary Angioedema

A Long Term Safety Study of BCX7353 in Hereditary Angioedema

APeX-S
Start date: February 16, 2018
Phase: Phase 2/Phase 3
Study type: Interventional

This is an open-label study to evaluate the long term safety and effectiveness of oral treatment with BCX7353 in preventing acute angioedema attacks in patients with Type I and Type II Hereditary Angioedema (HAE).

NCT ID: NCT03202784 Completed - Clinical trials for Hereditary Angioedema

A Relative Bioavailability Study of Two Formulations of BCX7353

Start date: February 27, 2017
Phase: Phase 1
Study type: Interventional

This is an open-label, randomized study to investigate the relative bioavailability of two formulations of BCX7353 and to determine if there is a food effect

NCT ID: NCT03136237 Completed - Clinical trials for Hereditary Angioedema

A Drug-Drug Interaction Study to Evaluate Drug Transporter Interactions

Start date: February 17, 2017
Phase: Phase 1
Study type: Interventional

This is an open-label, three part study to evaluate the effect of BCX7353 on drug transporters as well as the effect of an inhibitor of drug transport on BCX7353.

NCT ID: NCT03029728 Completed - Clinical trials for Hereditary Angioedema

Biomarker for Hereditary AngioEdema Disease

BioHAE
Start date: August 20, 2018
Phase:
Study type: Observational

International, 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

NCT ID: NCT02854397 Terminated - Healthy Volunteers Clinical Trials

Determination of Specific Biomarkers of Acute Attack of Angioedema Within Pediatric Population

BRADYKID
Start date: February 15, 2016
Phase:
Study type: Observational

In emergency room, this is crucial to diagnose an acute attack of hereditary angioedema (HAE) to quickly provide the efficient treatment. Currently, there is no specific biomarker for acute attack of bradykinin-mediated angioedema to help clinicians for patient care. However, previous works are carried out for that purpose. All the potential candidate biomarkers must be validated in prospective studies to estimate their specificity and sensitivity values, and to understand their potential utility in patient care. The main goal of this clinical trial is to estimate the diagnostic value of VE-cadherin in pediatric population, for the differential diagnosis between HAE crisis and angioedema resulting of mast cell activation crisis (the main differential diagnosis of HAE).

NCT ID: NCT02819102 Completed - Clinical trials for Hereditary Angioedema

An Open-label Drug-Drug Interaction Study to Evaluate the Effect of BCX7353 on Cytochrome P450 Enzyme Activity Using Probe Substrates

Start date: March 2016
Phase: Phase 1
Study type: Interventional

This is an open-label, single sequence study to evaluate the effect of BCX7353 on hepatic and intestinal cytochrome P450 enzymes using probe substrate drugs in healthy subjects. Pharmacokinetics of the probe substrate drugs will be measured prior to and following administration of multiple doses of BCX7353.

NCT ID: NCT02670720 Terminated - Clinical trials for Hereditary Angioedema

Open-label, Long-term Safety Study of Avoralstat in Subjects With Hereditary Angioedema

OPuS-4
Start date: December 2015
Phase: Phase 3
Study type: Interventional

This is an open-label study designed to evaluate the long-term safety of prophylactic avoralstat (500 mg three times daily) when given to approximately 150 patients with hereditary angioedema (HAE) for a duration of up to 72 weeks. The study will also evaluate the long-term efficacy and impact on quality of life of avoralstat prophylactic treatment.

NCT ID: NCT02448264 Completed - Clinical trials for Hereditary Angioedema

First-in-Human Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of BCX7353 in Healthy Western and Japanese Volunteers

Start date: May 2015
Phase: Phase 1
Study type: Interventional

This is a 3-part Phase 1 dose-ranging study to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of single (Part 1) and multiple (Part 2) ascending doses of BCX7353 in healthy subjects, and single and multiple doses of BCX7353 in healthy Japanese subjects. Pharmacokinetics is an analysis of how the body handles the study drug BCX7353 and pharmacodynamics is an analysis of the activity the study drug BCX7353 may have in the body.