Agammaglobulinemia, Hypogammaglobulinemia, Primary Immunodeficiency Diseases (PID)
Conditions
Keywords
Gammaglobulin
Brief summary
The purpose of this study is to determine the pharmacokinetics, efficacy and safety of Immune Globulin Intravenous (Human), 10% TVR (Triple Virally Reduced) Solution in subjects with primary immunodeficiency (PID) manifesting as hypo- or agammaglobulinemia. Subjects are treated every 21 days and receive a total of 12 infusions: for the first 3 infusions subjects receive GAMMAGARD S/D to ensure a steady-state and to acquire data with a licensed product; for the remaining 9 infusions subjects receive IGIV, 10% TVR Solution.
Interventions
DRUGImmune Globulin Intravenous (Human), 10% TVR (Triple Virally Reduced) Solution
DRUGGammagard S/D (Solvent/Detergent)
Sponsors
Baxalta now part of Shire
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Subjects will be eligible for study entry if they: * are at least 18 years old * have a form of primary immunodeficiency (PID) as described by Rosen et al, 1999 16 manifesting as agammaglobulinemia (X-linked) or hypogamma-globulinemia (common variable immunodeficiency), requiring immunoglobulin replacement therapy * have had regular treatment for at least three months with either intravenous immunoglobulin preparations or immunoglobulin preparations for intramuscular use given subcutaneously * have serum IgG levels greater than or equal to 5 g/L as determined by the local laboratory at screening * if female of childbearing potential, agree to employ adequate birth control measures during the study * have given written informed consent
Exclusion criteria
Subjects will not be eligible for study entry if they: * had severe adverse reactions to treatment with immunoglobulin preparations during the last three treatments before inclusion into the study * suffer from documented selective IgA deficiency with antibodies against IgA * have an acute infection that requires intravenous antibiotic treatment (Last treatment day should be seven days before study entry.) * are known to be infected with HIV, HCV, or HBV * are at high risk of contracting blood-borne viral infections through parenteral drug abuse or life style * suffer from congestive heart failure and receive on-demand treatment with furosemide * show renal dysfunction defined as serum creatinine greater than or equal to 1.5 mg/dL at baseline visit * received another investigational drug in the three weeks preceding study entry * in case of females, are pregnant or nursing mothers
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pharmacokinetics: Trough levels of total immunoglobulin G (IgG) after treatment with Immune Globulin Intravenous (Human), 10% Triple Virally Reduced Solution (IGIV, 10% TVR Solution) | 21 days after each infusion (i.e., before the next infusion) of the study drug and at the last visit |
Countries
Finland, Sweden
Outcome results
None listed