Clinical trial NCT00157079: Safety and Efficacy Study of a 10% Intravenous Immune Globulin Solution in Subjects With Primary Immunodeficiency Disorders
Official title: A Clinical Investigation to Assess the Safety and Efficacy of Immune Globulin Intravenous (Human), 10% in Subjects With Primary Immunodeficiency Disorders
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Primary Immunodeficiency Diseases (PID)
Immune Thrombocytopenic Purpura (ITP)
Kawasaki Syndrome
Keywords: PID
Immunodeficiency
Immune Thrombocytopenic Purpura (ITP)
Kawasaki syndrome
Lead sponsor: Takeda
Sponsor class: INDUSTRY
First posted: 2005-09-12
Enrollment: 61
Sex: ALL
Minimum age (years): 24
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: Mean number of acute serious bacterial infections per participant per year
timeFrame: Throughout the study period of 18 months
Secondary outcomes:
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Children´s Hospital Los Angeles
state: California
city: Stanford
country: United States
facility: Stanford University Medical Center
state: California
city: Englewood
country: United States
facility: 1st Allergy and Clinical Research Center
state: Colorado
city: North Palm Beach
country: United States
facility: Allergy Associates of the Palm Beaches
state: Florida
city: Tampa
country: United States
facility: University of South Florida; Asthma, Allergy & Immunology CRU
state: Florida
city: Chicago
country: United States
facility: Rush Presbyterian - St. Lukes Medical Center
state: Illinois
city: Boston
country: United States
facility: Children´s Hospital Boston
state: Massachusetts
city: Omaha
country: United States
facility: Allergy, Asthma & Immunology Assoc.
state: Nebraska
city: Papillion
country: United States
facility: Asthma and Allergy Center
state: Nebraska
city: Bronx
country: United States
facility: Montefiore Medical Center, Albert Einstein College of Medicine
state: New York
city: Dallas
country: United States
facility: Pediatric Allergy/Immunology Associates
state: Texas
Study officials:
affiliation: Takeda
name: Study Director
role: STUDY_DIRECTOR
References: