Safety, Pharmacokinetic and Efficacy Study of a 10% Triple Virally Reduced Intravenous Immune Globulin Solution in Patients With Primary Immunodeficiency (Hypo- or Agammaglobulinemia)

Study Overview
=================
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.

Official Title
-----------------
Prospective Open-Label Study of Pharmacokinetics, Efficacy and Safety of Immune Globulin Intravenous (Human), 10% TVR Solution in Patients With Hypo- or Agammaglobulinemia

Conditions
-----------------
Primary Immunodeficiency Diseases (PID), Agammaglobulinemia, Hypogammaglobulinemia

Intervention / Treatment
-----------------
* Drug: Immune Globulin Intravenous (Human), 10% TVR (Triple Virally Reduced) Solution
* Drug: Gammagard S/D (Solvent/Detergent)


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Immune Globulin Intravenous (Human), 10% TVR (Triple Virally Reduced) Solution|nan|
|Drug: Gammagard S/D (Solvent/Detergent)|nan|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Gammaglobulin