Status:
COMPLETED
Safety and Efficacy Study of a 10% Intravenous Immune Globulin Solution in Subjects With Primary Immunodeficiency Disorders
Lead Sponsor:
Baxalta now part of Shire
Conditions:
Primary Immunodeficiency Diseases (PID)
Immune Thrombocytopenic Purpura (ITP)
Eligibility:
All Genders
24+ years
Phase:
PHASE3
Brief Summary
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.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 25 2002
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 16 2003
Estimated Enrollment :
61 Patients enrolled
Trial Details
Trial ID
NCT00157079
Start Date
June 25 2002
End Date
December 16 2003
Last Update
August 24 2021
Active Locations (11)
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1
Children´s Hospital Los Angeles
Los Angeles, California, United States, 90027
2
Stanford University Medical Center
Stanford, California, United States, 94304-8786
3
1st Allergy and Clinical Research Center
Englewood, Colorado, United States, 80112
4
Allergy Associates of the Palm Beaches
North Palm Beach, Florida, United States, 33408