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

Baxalta now part of Shire11 sites in 1 country61 target enrollmentJune 25, 2002

ConditionsPrimary Immunodeficiency Diseases (PID)Immune Thrombocytopenic Purpura (ITP)Kawasaki Syndrome

Overview

Phase: Phase 3
Intervention: Not specified
Conditions: Primary Immunodeficiency Diseases (PID)
Sponsor: Baxalta now part of Shire
Enrollment: 61
Locations: 11
Primary Endpoint: Mean number of acute serious bacterial infections per participant per year
Status: Completed
Last Updated: 4 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

June 25, 2002

End Date

December 16, 2003

Last Updated

4 years ago

Study Type

Interventional

Study Design

Crossover

Sex

All

Investigators

Sponsor

Baxalta now part of Shire

Responsible Party

Sponsor

Eligibility 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