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

Baxalta

Status and phase

Completed

Phase 2

Conditions

Hypogammaglobulinemia

Primary Immunodeficiency Diseases (PID)

Agammaglobulinemia

Treatments

Drug: Gammagard S/D (Solvent/Detergent)

Drug: Immune Globulin Intravenous (Human), 10% TVR (Triple Virally Reduced) Solution

Study type

Interventional

Funder types

Industry

Identifiers

NCT00161993

160001

Details and patient eligibility

About

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.

Enrollment

24 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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