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

NCT00157079 | Completed Phase 3 FDA Drug

• 1 other identifier: 160101
• Study Type: interventional
• Target: 61
• Locations: 1 country
• Sites: 11

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.

Conditions

Primary Immunodeficiency Diseases (PID); Immune Thrombocytopenic Purpura (ITP); Kawasaki Syndrome

Keywords

PID; Immunodeficiency; Immune Thrombocytopenic Purpura (ITP); Kawasaki syndrome

Outcome Measures

Primary Outcomes (1)

• Mean number of acute serious bacterial infections per participant per year

  Throughout the study period of 18 months

Interventions

Immune Globulin Intravenous (Human), 10% BIOLOGICAL

Eligibility Criteria

• Age: 24 Months+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Baxalta now part of Shire: lead

Study Sites (11)

Children´s Hospital Los Angeles

Los Angeles, California, 90027, United States

Location

Stanford University Medical Center

Stanford, California, 94304-8786, United States

Location

1st Allergy and Clinical Research Center

Englewood, Colorado, 80112, United States

Location

Allergy Associates of the Palm Beaches

North Palm Beach, Florida, 33408, United States

Location

University of South Florida; Asthma, Allergy & Immunology CRU

Tampa, Florida, 33613, United States

Location

Rush Presbyterian - St. Lukes Medical Center

Chicago, Illinois, 60612, United States

Location

Children´s Hospital Boston

Boston, Massachusetts, 02115, United States

Location

Allergy, Asthma & Immunology Assoc.

Omaha, Nebraska, 68124, United States

Location

Asthma and Allergy Center

Papillion, Nebraska, 68046, United States

Location

Montefiore Medical Center, Albert Einstein College of Medicine

The Bronx, New York, 10461, United States

Location

Pediatric Allergy/Immunology Associates

Dallas, Texas, 75230, United States

Location

MeSH Terms

Conditions

Primary Immunodeficiency Diseases; Purpura, Thrombocytopenic, Idiopathic; Mucocutaneous Lymph Node Syndrome; Immunologic Deficiency Syndromes

Interventions

gamma-Globulins

Condition Hierarchy (Ancestors)

Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Immune System Diseases; Purpura, Thrombocytopenic; Purpura; Blood Coagulation Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Thrombotic Microangiopathies; Thrombocytopenia; Blood Platelet Disorders; Cytopenia; Hemorrhagic Disorders; Autoimmune Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Skin Manifestations; Signs and Symptoms; Vasculitis; Vascular Diseases; Cardiovascular Diseases; Lymphatic Diseases; Skin Diseases, Vascular; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Study Director

  Takeda

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 8, 2005
• First Posted: September 12, 2005
• Study Start: June 25, 2002
• Primary Completion: December 16, 2003
• Study Completion: December 16, 2003
• Last Updated: August 24, 2021

Record last verified: 2021-08

Locations

US (11)