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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00157079
Recruitment Status : Completed
First Posted : September 12, 2005
Last Update Posted : January 18, 2018
Information provided by (Responsible Party):
Shire ( Baxalta now part of Shire )

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.

Condition or disease Intervention/treatment Phase
Primary Immunodeficiency Diseases (PID) Immune Thrombocytopenic Purpura (ITP) Kawasaki Syndrome Biological: Immune Globulin Intravenous (Human), 10% Phase 3

Study Type : Interventional  (Clinical Trial)
Allocation: Randomized
Intervention Model: Crossover Assignment
Primary Purpose: Treatment
Official Title: A Clinical Investigation to Assess the Safety and Efficacy of Immune Globulin Intravenous (Human), 10% in Subjects With Primary Immunodeficiency Disorders
Actual Study Start Date : June 25, 2002
Actual Primary Completion Date : December 16, 2003
Actual Study Completion Date : December 16, 2003

Information from the National Library of Medicine

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Ages Eligible for Study:   24 Months and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00157079

United States, California
Children´s Hospital Los Angeles
Los Angeles, California, United States, 90027
Stanford University Medical Center
Stanford, California, United States, 94304-8786
United States, Colorado
1st Allergy and Clinical Research Center
Englewood, Colorado, United States, 80112
United States, Florida
Allergy Associates of the Palm Beaches
North Palm Beach, Florida, United States, 33408
University of South Florida; Asthma, Allergy & Immunology CRU
Tampa, Florida, United States, 33613
United States, Illinois
Rush Presbyterian - St. Lukes Medical Center
Chicago, Illinois, United States, 60612
United States, Massachusetts
Children´s Hospital Boston
Boston, Massachusetts, United States, 02115
United States, Nebraska
Allergy, Asthma & Immunology Assoc.
Omaha, Nebraska, United States, 68124
Asthma and Allergy Center
Papillion, Nebraska, United States, 68046
United States, New York
Montefiore Medical Center, Albert Einstein College of Medicine
Bronx, New York, United States, 10461
United States, Texas
Pediatric Allergy/Immunology Associates
Dallas, Texas, United States, 75230
Sponsors and Collaborators
Baxalta now part of Shire
Principal Investigator: Mark Stein, MD Allergy Associatesof the Palm Beaches, North Palm Beach, FL
Principal Investigator: Dale Umetsu, MD, PhD Stanford University Medical Center, Stanford, CA
Principal Investigator: Lynda Schneider, MD Children´s Hospital, Boston, MA
Principal Investigator: Linda Ford, MD Asthma and Allergy Center, Papillion, NE
Principal Investigator: Joseph Church, MD Children´s Hospital Los Angeles, LA, CA
Principal Investigator: Roger Kobayashi, MD Allergy, Asthma & Immunology Assoc., Omaha, NE
Principal Investigator: James Moy, MD Rush Presbyterian - St. Lukes Medical Center, Chicago, IL
Principal Investigator: Arye Rubinstein, MD Albert Einstein College of Medicine, Bronx, NY
Principal Investigator: Richard Wasserman, MD Pediatric Allergy/Immunology Associates, Dallas, TX
Principal Investigator: Dennis Ledford, MD Asthma, Allergy & Immunology CRU, University of South Florida, Tampa, FL
Principal Investigator: Isaac Melamed, MD First Allergy and Clinical Research Center, Engelwood, CO

Responsible Party: Baxalta now part of Shire Identifier: NCT00157079     History of Changes
Other Study ID Numbers: 160101
First Posted: September 12, 2005    Key Record Dates
Last Update Posted: January 18, 2018
Last Verified: January 2018

Studies a U.S. FDA-regulated Drug Product: Yes

Keywords provided by Shire ( Baxalta now part of Shire ):
Immune Thrombocytopenic Purpura (ITP)
Kawasaki syndrome

Additional relevant MeSH terms:
Immunologic Deficiency Syndromes
Purpura, Thrombocytopenic
Purpura, Thrombocytopenic, Idiopathic
Mucocutaneous Lymph Node Syndrome
Immune System Diseases
Blood Coagulation Disorders
Hematologic Diseases
Pathologic Processes
Skin Manifestations
Signs and Symptoms
Thrombotic Microangiopathies
Blood Platelet Disorders
Hemorrhagic Disorders
Autoimmune Diseases
Vascular Diseases
Cardiovascular Diseases
Lymphatic Diseases
Skin Diseases, Vascular
Skin Diseases
Immunoglobulins, Intravenous
Rho(D) Immune Globulin
Immunologic Factors
Physiological Effects of Drugs