ZLB Behring (5950871) has launched VIRTUE Trial, a Phase IV clinical trial of the study medication Vivaglobin® (Immune Globulin Subcutaneous, Human), the first and only USFDA-approved subcutaneous immunoglobulin (Ig) treatment for patients with primary immunodeficiency (PI).
VIRTUE [Vivaglobin Investigator Research Trial on Use and Experience], which will enroll 100 PI patients at 50 sites across the United States is designed to evaluate patient satisfaction and annual rate of serious bacterial infection using Vivaglobin subcutaneous administration for one year after conversion from intravenous immunoglobulin therapy.
Thus, making VIRTUE the largest-ever trial of subcutaneous (i.e., under the skin) immunoglobulin therapy in the United States.
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 experience receiving the study medication and their previous intravenous treatment experience. Additionally, VIRTUE will identify which patients are more inclined to use SC treatment because of the improvement in their quality of life.
VIRTUE is now accepting applications from individuals who wish to enroll. Interested patients should call 1-800-504-5434.
Read the full press release.
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