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

• Sponsor: Baxalta now part of Shire (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00157079
• Collaborator: (none)
• Enrollment: 61
• Locations: 11
• Actual Duration (Months): 17.7
• Patients Per Site: 5.5
• Patients Per Site Per Month: 0.3

Study Details

Study Description

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 Design

• Study Type: Interventional
• Actual Enrollment: 61 participants
• 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: Jun 25, 2002
• Actual Primary Completion Date: Dec 16, 2003
• Actual Study Completion Date: Dec 16, 2003

Outcome Measures

Primary Outcome Measures

1. Mean number of acute serious bacterial infections per participant per year [Throughout the study period of 18 months]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 24 Months and Older
• 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Children´s Hospital Los Angeles	Los Angeles	California	United States	90027
2	Stanford University Medical Center	Stanford	California	United States	94304-8786
3	1st Allergy and Clinical Research Center	Englewood	Colorado	United States	80112
4	Allergy Associates of the Palm Beaches	North Palm Beach	Florida	United States	33408
5	University of South Florida; Asthma, Allergy & Immunology CRU	Tampa	Florida	United States	33613
6	Rush Presbyterian - St. Lukes Medical Center	Chicago	Illinois	United States	60612
7	Children´s Hospital Boston	Boston	Massachusetts	United States	02115
8	Allergy, Asthma & Immunology Assoc.	Omaha	Nebraska	United States	68124
9	Asthma and Allergy Center	Papillion	Nebraska	United States	68046
10	Montefiore Medical Center, Albert Einstein College of Medicine	Bronx	New York	United States	10461
11	Pediatric Allergy/Immunology Associates	Dallas	Texas	United States	75230

Sponsors and Collaborators

• Baxalta now part of Shire

Investigators

• Study Director: Study Director, Takeda

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Baxalta now part of Shire
• ClinicalTrials.gov Identifier: NCT00157079
• Other Study ID Numbers: 160101
• First Posted: Sep 12, 2005
• Last Update Posted: Aug 24, 2021
• Last Verified: Aug 1, 2021

• Studies a U.S. FDA-regulated Drug Product: Yes
• Keywords provided by Baxalta now part of Shire: PID; Immunodeficiency; Immune Thrombocytopenic Purpura (ITP); Kawasaki syndrome
• Additional relevant MeSH terms: Mucocutaneous Lymph Node Syndrome; Purpura; Purpura, Thrombocytopenic; Purpura, Thrombocytopenic, Idiopathic; Primary Immunodeficiency Diseases; Immunologic Deficiency Syndromes; Immunoglobulins; Antibodies; gamma-Globulins; Immunoglobulins, Intravenous; Rho(D) Immune Globulin

Study Results

No Results Posted as of Aug 24, 2021