Trial | NCT00157079  Report issue

Title

Safety and Efficacy Study of a 10% Intravenous Immune Globulin Solution in Subjects With Primary Immunodeficiency Disorders
A Clinical Investigation to Assess the Safety and Efficacy of Immune Globulin Intravenous (Human), 10% in Subjects With Primary Immunodeficiency Disorders

  • Phase

    Phase 3

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    61
The purpose of this study is to assess the safety and efficacy of Immune Globulin Intravenous (Human), 10% (IGIV 10%) in subjects with primary immunodeficiency disorders.
Study Started
Jun 25
2002
Primary Completion
Dec 16
2003
Study Completion
Dec 16
2003
Last Update
Aug 24
2021

Biological Immune Globulin Intravenous (Human), 10%

Criteria 

Inclusion Criteria:

Written informed consent obtained from either the subject or the subject's legally acceptable representative prior to any study-related procedures and study product administration
Diagnosis of a PID disorder as defined by World Health Organization criteria for which the subject has been receiving a regimen of IGIV infusions every 21 to 28 days over a period of at least 4 months pre-study at a dose of 300-600 mg/kg body weight
Subjects > 24 months of age
A negative serum pregnancy test for any female subject who is of childbearing potential.

Exclusion Criteria:

Subjects sero-positive at enrollment for one or more of the following: hepatitis B surface antigen (HBsAg), antibodies to hepatitis C virus (HCV), antibodies to human immunodeficiency virus (HIV) Types 1 or 2
Subjects with levels of alanine amino transferase (ALT) and aspartate amino transferase (AST) > 2.5 times the upper limit of normal for the testing laboratory. An AST > 2.5 times the upper limit of normal is allowable, if the ALT does not exceed the upper limit of the reference range for the testing laboratory
Subjects with neutropenia (defined as an ANC >= 1,000/mm3)
Subjects with serum creatinine levels greater than two times the upper limit of normal for age and gender
Subjects with malignancy or a history of malignancy
Subjects who received any blood or blood product exposure other than an IGIV and/or immune serum globulin (ISG) preparation within the 6 months prior to study entry
Subjects with an ongoing history of hypersensitivity or persistent reactions (urticaria, breathing difficulty, severe hypotension, or anaphylaxis) following IGIV and/or ISG infusions
Subjects with selective complete IgA deficiency
Subjects with moderate levels of anti-IgA antibodies (>150), or subjects with lower anti-IgA antibodies who are naive to IGIV treatment. (Subjects with lower levels of IgA antibodies, whom the investigators know to have tolerated IgA containing IGIV preparations in the past, may be included if the investigator is comfortable with this)
Subjects receiving antibiotic therapy for the treatment of infection within 30 days prior to enrollment
Subjects who receive prophylactic antibiotics as part of their care regimen
Subjects participating in another clinical study involving an investigational product or device within 30 days prior to study entry
No Results Posted