Clinical trial NCT00161993: Safety, Pharmacokinetic and Efficacy Study of a 10% Triple Virally Reduced Intravenous Immune Globulin Solution in Patients With Primary Immunodeficiency (Hypo- or Agammaglobulinemia)
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Primary Immunodeficiency Diseases (PID)
Agammaglobulinemia
Hypogammaglobulinemia
Keywords: Gammaglobulin
Lead sponsor: Takeda
Sponsor class: INDUSTRY
First posted: 2005-09-13
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Pharmacokinetics: Trough levels of total immunoglobulin G (IgG) after treatment with Immune Globulin Intravenous (Human), 10% Triple Virally Reduced Solution (IGIV, 10% TVR Solution)
timeFrame: 21 days after each infusion (i.e., before the next infusion) of the study drug and at the last visit
Secondary outcomes:
Other outcomes:
Locations:
city: Tampere
country: Finland
facility: Tampere University Hospital
city: Turku
country: Finland
facility: Turku University Central Hospital
city: Gothenburg
country: Sweden
facility: SU/Sahlgrenska
city: Lund
country: Sweden
facility: University Hospital Lund
city: Malmö
country: Sweden
facility: University Hospital MAS
city: Sundsvall
country: Sweden
facility: Sundsvall Hospital
Study officials:
affiliation: Takeda
name: Study Director
role: STUDY_DIRECTOR
References: