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EASSI - Evaluation of the Safety of Self-Administration With Icatibant

2010-07-15 17:00:00 | BioPortfolio

Summary

This study is being conducted to explore the clinical safety, local tolerability, convenience and effectiveness of self-treatment of hereditary angioedema (HAE) attacks with subcutaneous injections of icatibant.

Study Design

Control: Uncontrolled, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Conditions

Hereditary Angioedema

Intervention

Icatibant

Location

Universitätsklinik für Dermatologie und Venerologie
Graz
Austria
8036

Status

Recruiting

Source

Shire Human Genetic Therapies, Inc.

Results (where available)

View Results

Links

Published on BioPortfolio: 2010-07-15T17:00:00-0400

Clinical Trials [192 Associated Clinical Trials listed on BioPortfolio]

Subcutaneous Treatment With Icatibant for Acute Attacks of Hereditary Angioedema (HAE)

Primary Outcome Measures: Symptom relief (patient) Secondary Outcome Measures: Safety and tolerability Additional efficacy assessments Pharmacoeconomics

AMelioration of Angiotensin Converting Enzyme Inhibitor Induced Angioedema Study

This is a multicenter study recruiting patients with angioedema induced by ACEI. Open-label treatment with subcutaneous Icatibant compared to a historic group of 47 patients with ACE inhi...

Epidemiological Analysis for Hereditary Angioedema Disease (EHA Study)

To explore the feasibility of a new Dried Blood Spot (DBS) filtercard-based screening algorithm and thereby analyzing the prevalence of the Hereditary Angioedema in patients with unclear r...

The Role of the Coagulation Pathways in Recurrent Angioedema

Previous studies reported infraclinical modifications of the homeostasis in chronic urticaria, recurrent idiopathic angioedema and hereditary angioedema. This study aim to compare groups w...

Cinryze for the Treatment of Hereditary Angioedema Attacks in Children Under the Age of 12

The objectives of the study are to: 1. Evaluate the dose response and the pharmacokinetics (PK)/pharmacodynamics (PD) of intravenous (IV) administration of Cinryze for the treatmen...

PubMed Articles [372 Associated PubMed Articles listed on BioPortfolio]

Management of patients with hereditary angioedema in Germany: comparison to other countries in the Icatibant Outcome Survey.

The Icatibant Outcome Survey (IOS; NCT01034969) is a Shire-sponsored, international, observational study monitoring the safety and effectiveness of icatibant, a bradykinin B2 receptor antagonist appro...

A hereditary angioedema screening on an index case: Turkey.

Hereditary angioedema (HAE) is characterised by recurrent episodes of angioedema and can be fatal.

Pediatricians diagnosed few patients with childhood-presented hereditary angioedema: Icatibant Outcome Survey findings.

Brazilian Guidelines for Hereditary Angioedema Management - 2017 Update Part 1: Definition, Classification and Diagnosis.

Hereditary angioedema is an autosomal dominant disease characterized by recurrent angioedema attacks with the involvement of multiple organs. The disease is unknown to many health professionals and is...

Idiopathic non-histaminergic acquired angioedema vs. hereditary angioedema.

The mechanism of idiopathic non-histaminergic acquired angioedema (InH-AAE) has not yet been precisely elucidated. This condition is characterized by recurrent angioedema without wheals.

Medical and Biotech [MESH] Definitions

Forms of hereditary angioedema that occur due to mutations in the gene for COMPLEMENT C1 INHIBITOR PROTEIN. Type I hereditary angioedema is associated with reduced serum levels of complement C1 inhibitor protein. Type II hereditary angioedema is associated with the production of a non-functional complement C1 inhibitor protein.

A form of hereditary angioedema that occurs in women and is precipitated or worsened by high ESTROGEN levels. It is associated with mutations in the gene for FACTOR XII that result in its increased activity.

Swelling involving the deep DERMIS, subcutaneous, or submucosal tissues, representing localized EDEMA. Angioedema often occurs in the face, lips, tongue, and larynx.

An endogenous 105-kDa plasma glycoprotein produced primarily by the LIVER and MONOCYTES. It inhibits a broad spectrum of proteases, including the COMPLEMENT C1R and the COMPLEMENT C1S proteases of the CLASSICAL COMPLEMENT PATHWAY, and the MANNOSE-BINDING PROTEIN-ASSOCIATED SERINE PROTEASES. C1-INH-deficient individuals suffer from HEREDITARY ANGIOEDEMA TYPES I AND II.

Stable blood coagulation factor activated by contact with the subendothelial surface of an injured vessel. Along with prekallikrein, it serves as the contact factor that initiates the intrinsic pathway of blood coagulation. Kallikrein activates factor XII to XIIa. Deficiency of factor XII, also called the Hageman trait, leads to increased incidence of thromboembolic disease. Mutations in the gene for factor XII that appear to increase factor XII amidolytic activity are associated with HEREDITARY ANGIOEDEMA TYPE III.

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