Phase 3 Study of Immune Globulin Intravenous (Human)IVIG-SN™ in Subjects With Primary Immunodeficiency

Completed · Phase 3

Conditions studied: Immunologic Deficiency Syndrome

In brief

The purpose of this study is to evaluate the safety, efficacy and pharmacokinetics of Immune Globulin Intravenous (Human) IVIG-SN™ in subjects with primary immunodeficiency diseases.

Key facts

Study ID: NCT01406470
Run by: Green Cross Corporation
People needed: 45
Starts: 2011-09-01
Expected to finish: 2013-07-01
Last updated by the study team: 2014-01-10

Who can join

Age: 2 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Subjects with a confirmed clinical diagnosis of a Primary Immunodeficiency Disease as defined by IUIS (International Union of Immunological Societies) and require treatment with IVIG. Documented agammaglobulinemia or hypogammaglobulinemia (preferably with documented antibody deficiency).
Male or female, ages 2 to 70 years.
The subject has received 300-900 mg/kg of a licensed IGIV therapy at 21 or 28 day intervals for at least 3 months prior to this study.
At least 2 documented IgG trough levels of ≥ 5 g/L are obtained at two infusion cycles (21 or 28 days) within 12 months prior to study enrollment.
Subject is willing to comply with all requirements of the protocol.
Females of child-bearing potential with a negative urine pregnancy test and who agree to employ adequate birth control measures during the study.
Subject, parent or guardian has signed the informed consent form and a child assent form if appropriate. Pediatric subjects are defined as 2-17 years of age at study entry and will require assent forms as appropriate per study documentation and regulations of the local jurisdiction.
Authorization to access personal health information.
Subjects currently participating in a clinical trial with another experimental IVIG may be enrolled if they have received stable IVIG therapy for at least 3 infusion cycles prior to receiving IVIG-SN™ and all inclusion and exclusion criteria are satisfied. Other IVIGs will be prohibited between the first infusion of IVIG-SN™ and Follow Up Visit 1.
Subjects currently participating in a trial of SCIG can be enrolled if they are switched to IVIG for three infusion cycles (21 or 28 days) prior to enrollment in this study.

You may not qualify if…

Subject has secondary immunodeficiency.
Subject was newly diagnosed and has not been treated with immunoglobulin or has been diagnosed with dysgammaglobulinemia or isolated IgG subclass deficiency.
Subject has a history of repeated reactions or hypersensitivity to IVIG or other injectable forms of IgG.
Subject has a history of thrombotic events including deep vein thrombosis, cerebrovascular accident, pulmonary embolism or transient ischemic attacks, or myocardial infarction, as defined by at least 1 event in subject's lifetime.
Subject has IgA deficiency and is known to have antibodies to IgA.
Subject has received blood products other than human albumin or human immunoglobulin within 12 months prior to enrollment.
Subject has significant protein losing enteropathy, nephrotic syndrome or lymphangiectasia.
Subject has an acute infection as documented by culture or diagnostic imaging and/or a body temperature exceeding 38.5 °C (101.3 °F) within 7 days prior to screening
Subject has a known history or is positive at enrollment for human immunodeficiency virus (HIV) type 1/2 by NAT or hepatitis B virus (HBsAg and NAT) or hepatitis C virus (by NAT), or hepatitis A virus (by NAT).
Subject has levels of alanine aminotransferase (ALT) or aspartate aminotransferase (AST) > 2.5 times of the upper limit of normal for the laboratory designated for the study.
Subject is using an implanted venous access device
Subject has profound anemia or persistent severe neutropenia (≤ 1000 neutrophils per mm3).
Subject has a severe chronic condition such as renal failure (creatinine concentration > 2.0 times the upper limit of normal) with proteinuria, congestive heart failure (New York Heart Association III/IV), cardiomyopathy, cardiac arrhythmia associated with thromboembolic events (e.g. atrial fibrillation), unstable or advanced ischemic heart disease, or hyperviscosity, or any other condition that the investigator believes is likely to interfere with evaluation of the study drug or with satisfactory conduct of the trial.
Subject has a history of a malignant disease other than properly treated carcinoma in situ of the cervix or basal cell or squamous cell carcinoma of the skin within 24 months prior to enrollment.
Subject has history of epilepsy or multiple episodes of migraine not completely controlled by medication.
Subject is receiving the following medication:
Steroids (oral or parenteral daily dose of ≥ 0.15 mg/kg/day of prednisone or equivalent).
Other immunosuppressive drugs or chemotherapy.
Females who are pregnant, breast feeding or planning a pregnancy during the course of the study. Women who become pregnant during the study will be withdrawn from the study.
Subject has participated in another clinical study within 3 weeks prior to study enrollment.

Where it is running

University of Alabama Hospital — Birmingham, Alabama, United States
Allergy Associates of the Palm Beaches — North Palm Beach, Florida, United States
Rush University Medical Center — Chicago, Illinois, United States
University of Iowa Hospitals and Clinics — Iowa City, Iowa, United States
Optimed Research, LTD — Columbus, Ohio, United States
Dallas Allergy Immunology — Dallas, Texas, United States
AARA Research Center — Dallas, Texas, United States
Children's Hospital of Richmond — Richmond, Virginia, United States
Bellingham Asthma, Allergy & Immunology Clinic — Bellingham, Washington, United States
Gordon Sussman Clinical Research Inc. — Toronto, Ontario, Canada
The Hospital for Sick Children — Toronto, Ontario, Canada

Full record on ClinicalTrials.gov

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