Has your child been diagnosed with primary humoral immunodeficiency?
An Open-Label, Single-Arm, Historically Controlled, Prospective, Multicenter Phase III Study to Evaluate the Pharmacokinetics and Safety of Immune Globulin Intravenous (Human) GC5107 in Pediatric Subjects with Primary Humoral Immunodeficiency.
- Primary humoral immunodeficiency (PHID) occurs in persons with inherited defects of their immune systems
- Subjects are unable to mount an immune response to microorganisms and may experience recurrent protozoal, bacterial, fungal and viral infections
- Prophylactic treatment with immune globulin has been shown to increase the time free from serious bacterial infection, decrease the incidence of overall bacterial infections and to reduce the number of hospitalizations resulting from infection.
- Compensation for time and travel
- Free medication and study related care
Study Participant Criteria :
- 2 to 17 years of age
- Male or female
- Confirmed and documented clinical diagnosis of Primary Humoral Immunodeficiency, including hypogammaglobulinemia or agammaglobulinemia
Study Participant Expectations:
- 12-month treatment period
- 19 visits to research clinic
“Did You Know”
- Replacement with human immune globulin infusions is standard practice for all patients with primary antibody deficiencies