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

Condition(s) targeted: Hypogammaglobulinemia; Agammaglobulinemia; Primary Immunodeficiency (PID)

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

Phase: Phase 2

Status: Completed

Sponsored by: Baxalta US Inc.

Official(s) and/or principal investigator(s):
Baxter BioScience Investigator, Principal Investigator, Affiliation: Baxter BioScience

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

Study design: Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Minimum age: 18 Years. Maximum age: N/A. Gender(s): 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

Tampere University Hospital, Tampere 33 521, Finland

Turku University Central Hospital, Turku 205 20, Finland

SU/Sahlgrenska, Gothenburg 41345, Sweden

University Hospital Lund, Lund 221 85, Sweden

University Hospital MAS, Malmö 205 02, Sweden

Sundsvall Hospital, Sundsvall 851 86, Sweden

Starting date: June 2002
Last updated: June 26, 2015