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.

Condition	Intervention	Phase
Hypogammaglobulinemia Agammaglobulinemia Primary immunodeficiency (PID)	Drug: Immune Globulin Intravenous (Human), 10% TVR (Triple Virally Reduced) Solution  Drug: Gammagard S/D (Solvent/Detergent)	Phase II

Further Study Details: 

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

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

Finland
      Turku University Central Hospital, Turku,  205 20,  Finland
      Tampere University Hospital, Tampere,  33 521,  Finland
Sweden
      SU/Sahlgrenska, GOTHENBURG,  41345,  Sweden
      University Hospital MAS, Malmö,  205 02,  Sweden
      Sundsvall Hospital, SUNDSVALL,  851 86,  Sweden
      University Hospital Lund, Lund,  221 85,  Sweden

Study chairs or principal investigators

Baxter BioScience Investigator,  Principal Investigator,  Baxter BioScience   

Study ID Numbers:  160001
Last Updated:  September 12, 2005
Record first received:  September 8, 2005
ClinicalTrials.gov Identifier:  NCT00161993
Health Authority: Sweden: Medical Products Agency; Finland: National Agency for Medicines
ClinicalTrials.gov processed this record on 2005-09-13