Research Study Summary
An open-label, multi-center study to evaluate the safety and pharmacokinetics of IGSC 20% administered for 6 months in subjects with primary immunodeficiency
Primary Immunodeficiency (PI) diseases are a family of congenital disorders of the immune system that lead to an increase in frequency of infections, notably, but not limited to, bacterial infections of the respiratory tract. Patients with PI do not have the healthy antibodies to fight off the infections and often are receiving immunoglobulin therapy to repair, stimulate, or enhance the body’s natural immune responses.
This study will look to compare the blood levels of Immune Globulin Injection (Human), 10% when it is given intravenously (IV, or in the vein) to the blood levels of IGSC 20% when it is given subcutaneously (SC, or under the skin) and to find out if IGSC 20% is safe when given to adults and children. IGIV-C 10%, has been approved for sale by the Food and Drug Administration (FDA), to be given as IV and subcutaneous injections.
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CW ID: 216050
Date Last Changed:
June 14, 2016
Clinical Trial Snapshot
- Both Male and Female
- 2 to 75 Years
- Overall Status
- Grifols Therapeutics
- Facility Type
- Documented and confirmed pre-existing diagnosis of PI with features of hypogammaglobulinemia requiring IgG replacement therapy including but not limited to
the following humoral-based immunodeficiency syndromes (eg, X-linked agammaglobulinemia, common variable immunodeficiency), and combined
immunodeficiency syndromes without lymphocytopenia (eg, hyper immunoglobulin M [IgM] immunodeficiency syndrome).
- The subject has not had an SBI within the last 3 months prior to Screening.
- Currently on IgG replacement therapy (via IV or SC infusion) for ≥3 consecutive months. Subjects receiving IVIG prior to study must receive a dosage of 300 to 800 mg/kg per infusion.
- Documented (at least once within previous 3 months) IgG trough level of ≥500 mg/dL on current IgG replacement therapy regimen.
- Screening trough IgG levels must be ≥500 mg/dL.
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