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

Primary Immunodeficiency Diseases (PID) Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00157079
• Other study ID #: 160101
• Status: Completed
• Phase: Phase 3
• Start date: June 25, 2002
• Est. completion date: December 16, 2003

Study information

• Verified date: August 2021
• Source: Takeda
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 61
• Est. completion date: December 16, 2003
• Est. primary completion date: December 16, 2003
• Accepts healthy volunteers: No
• Gender: All
• Age group: 24 Months and older

Eligibility

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

Related Conditions & MeSH terms

• Immune Thrombocytopenic Purpura (ITP)
• Immunologic Deficiency Syndromes
• Kawasaki Syndrome
• Mucocutaneous Lymph Node Syndrome
• Primary Immunodeficiency Diseases (PID)
• Purpura
• Purpura, Thrombocytopenic
• Purpura, Thrombocytopenic, Idiopathic

Intervention

Biological:
• Immune Globulin Intravenous (Human), 10%

Locations

Country	Name	City	State
United States	Children´s Hospital Boston	Boston	Massachusetts
United States	Montefiore Medical Center, Albert Einstein College of Medicine	Bronx	New York
United States	Rush Presbyterian - St. Lukes Medical Center	Chicago	Illinois
United States	Pediatric Allergy/Immunology Associates	Dallas	Texas
United States	1st Allergy and Clinical Research Center	Englewood	Colorado
United States	Children´s Hospital Los Angeles	Los Angeles	California
United States	Allergy Associates of the Palm Beaches	North Palm Beach	Florida
United States	Allergy, Asthma & Immunology Assoc.	Omaha	Nebraska
United States	Asthma and Allergy Center	Papillion	Nebraska
United States	Stanford University Medical Center	Stanford	California
United States	University of South Florida; Asthma, Allergy & Immunology CRU	Tampa	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Baxalta now part of Shire

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean number of acute serious bacterial infections per participant per year		Throughout the study period of 18 months