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Safety and Efficacy Study of a 10% Intravenous Immune Globulin Solution in Subjects With Primary Immunodeficiency Disorders

Information source: Baxter Healthcare Corporation
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Primary Immunodeficiency Disorders; Immune Thrombocytopenic Purpura (ITP); Kawasaki Syndrome

Intervention: Immune Globulin Intravenous (Human), 10% (Procedure)

Phase: Phase 3

Status: Completed

Sponsored by: Baxter Healthcare Corporation

Official(s) and/or principal investigator(s):
Joseph Church, MD, Principal Investigator, Affiliation: Children´s Hospital Los Angeles, LA, CA
Roger Kobayashi, MD, Principal Investigator, Affiliation: Allergy, Asthma & Immunology Assoc., Omaha, NE
Dennis Ledford, MD, Principal Investigator, Affiliation: Asthma, Allergy & Immunology CRU, University of South Florida, Tampa, FL
Isaac Melamed, MD, Principal Investigator, Affiliation: First Allergy and Clinical Research Center, Engelwood, CO
James Moy, MD, Principal Investigator, Affiliation: Rush Presbyterian - St. Lukes Medical Center, Chicago, IL
Arye Rubinstein, MD, Principal Investigator, Affiliation: Albert Einstein College of Medicine, Bronx, NY
Lynda Schneider, MD, Principal Investigator, Affiliation: Children´s Hospital, Boston, MA
Linda Ford, MD, Principal Investigator, Affiliation: Asthma and Allergy Center, Papillion, NE
Mark Stein, MD, Principal Investigator, Affiliation: Allergy Associatesof the Palm Beaches, North Palm Beach, FL
Richard L. Wasserman, MD, Principal Investigator, Affiliation: Pediatric Allergy/Immunology Associates, Dallas, TX
Dale T. Umetsu, MD, PhD, Principal Investigator, Affiliation: Stanford University Medical Center, Stanford, CA

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.

Clinical Details

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

Study design: Treatment, Randomized, Double-Blind, Uncontrolled, Crossover Assignment, Safety/Efficacy Study

Eligibility

Minimum age: 24 Months. Maximum age: N/A. Gender(s): Both.

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

Locations and Contacts

Children´s Hospital Los Angeles, Los Angeles, California 90027, United States

Stanford University Medical Center, Stanford, California 94304-8786, United States

1st Allergy and Clinical Research Center, Engelwood, Colorado 80112, United States

University of South Florida; Asthma, Allergy & Immunology CRU, Tampa, Florida 33613, United States

Allergy Associates of the Palm Beaches, North Palm Beach, Florida 33408, United States

Rush Presbyterian - St. Lukes Medical Center, Chicago, Illinois 60612, United States

Children´s Hospital Boston, Boston, Massachusetts 02115, United States

Allergy, Asthma & Immunology Assoc., Omaha, Nebraska 68124, United States

Asthma and Allergy Center, Papillion, Nebraska 68046, United States

Montefiore Medical Center, Albert Einstein College of Medicine, Bronx, New York 10461, United States

Pediatric Allergy/Immunology Associates, Dallas, Texas 75230, United States

Additional Information

Starting date: June 2002
Ending date: December 2003
Last updated: October 18, 2006

Page last updated: June 20, 2008

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