ZLB BEHRING BEGINS PHASE IV STUDY OF VIVAGLOBIN
ZLB Behring has announced the start of the VIRTUE trial, a Phase IV trial of Vivaglobin (immune globulin subcutaneous, human), the first and only FDA-approved subcutaneous immunoglobulin treatment for patients with primary immunodeficiency. The trial will evaluate patient satisfaction and annual rate of serious bacterial infection using Vivaglobin subcutaneous administration for one year after switching from intravenous immunoglobulin therapy.
The study will enroll 100 primary immunodeficiency patients at 50 sites, making it the largest-ever trial of subcutaneous immunoglobulin therapy in the U.S. Patients enrolled in the study will self-administer the study medication for one year. During the trial period, patients will be asked to assess overall health-related quality of life, comparing their experience receiving the study medication and their previous intravenous treatment experience.
Vivaglobin, which was approved by the FDA in January of this year, is delivered directly under the skin via a small portable pump. In Phase III trials, the study medication was shown to be a safe and effective immunoglobulin replacement therapy. In those studies, 65 patients self-administered Vivaglobin at home every week for 12 months. The average annual rate of serious bacterial infections, the primary endpoint, was 0.04 infections per subject per year.
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