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

First Received on September 8, 2005.   Last Updated on October 18, 2006   History of Changes
Sponsor: Baxter Healthcare Corporation
Information provided by: Baxter Healthcare Corporation
ClinicalTrials.gov Identifier: NCT00161993
  Purpose

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

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Baxter Healthcare Corporation:

Study Start Date: June 2002
Estimated Study Completion Date: September 2003
  Eligibility

Ages Eligible for Study:   18 Years and older
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00161993

Locations
Finland
Tampere University Hospital
Tampere, Finland, 33 521
Turku University Central Hospital
Turku, Finland, 205 20
Sweden
SU/Sahlgrenska
Gothenburg, Sweden, 41345
University Hospital Lund
Lund, Sweden, 221 85
University Hospital MAS
Malmö, Sweden, 205 02
Sundsvall Hospital
Sundsvall, Sweden, 851 86
Sponsors and Collaborators
Baxter Healthcare Corporation
Investigators
Principal Investigator: Baxter BioScience Investigator Baxter BioScience
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00161993     History of Changes
Other Study ID Numbers: 160001
Study First Received: September 8, 2005
Last Updated: October 18, 2006
Health Authority: Sweden: Medical Products Agency;   Finland: Finnish Medicines Agency

Keywords provided by Baxter Healthcare Corporation:
Gammaglobulin

Additional relevant MeSH terms:
Agammaglobulinemia
Immunologic Deficiency Syndromes
Blood Protein Disorders
Hematologic Diseases
Lymphoproliferative Disorders
Lymphatic Diseases
Immune System Diseases
Antibodies
Immunoglobulins
Immunoglobulins, Intravenous
Rho(D) Immune Globulin
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on February 09, 2012