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Observational Safety Study for KALBITOR (Ecallantide) in the Treatment of Acute Attacks of Hereditary Angioedema

2014-08-27 03:16:15 | BioPortfolio

Summary

The objective of this study is to evaluate the formation of antibodies, the occurence of allergic reactions, and the risk of hypercoagulability and hypocoagulability in patients treated with KALBITOR (ecallantide).

Description

The objective of this study is to evaluate immunogenicity and hypersensitivity upon exposure to KALBITOR, in particular:

1. Determine the rate of anaphylaxis and Type I hypersensitivity reactions upon exposure to KALBITOR.

2. Determine the rate of seroconversion to anti-ecallantide antibodies upon exposure to KALBITOR.

3. Determine the rate of adverse events related to disordered coagulation (hypercoagulability and hypocoagulability) upon exposure to KALBITOR.

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Conditions

Hereditary Angioedema

Location

Family Allergy and Asthma Center, PC
Atlanta,
Georgia
United States
30342

Status

Recruiting

Source

Dyax Corp.

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:16:15-0400

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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.

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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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