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CSL Behring starts Phase I/II trial of treatment candidate for hereditary angioedema

Thursday, May 03 2012 | Comments
Evidence Grade 0 What's This?
CSL Behring began a Phase I/II study to investigate a volume-reduced, subcutaneous formulation of C1-esterase inhibitor (C1-INH) concentrate in adults with hereditary angioedema (HAE) type I or type II.

The open-label trial is being conducted as part of the COMPACT program, which is assessing optimal management in preventing angioedema with low-volume, subcutaneous C1-INH replacement therapy.

After an initial IV injection of C1-INH, each of the trial participants will be assigned to receive a single subcutaneous injection of the volume-reduced formulation of C1-INH twice weekly for four weeks. The study subjects will participate in two of these treatment periods with two different doses of volume-reduced C1-INH.

During the trial, researchers will monitor C1-INH levels in the blood and will evaluate the drug's safety and tolerability at different doses.

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