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

NCT ID: NCT01406470

Last Updated: 2014-01-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 45 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-09-30
• Study Completion Date: 2013-07-31

Brief Summary

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.

Detailed Description

This is an open-label, single-arm, historically controlled, prospective, multicenter phase III study to evaluate the safety, efficacy and pharmacokinetics of Immune Globulin Intravenous (Human) IVIG-SN™ in subjects with primary immunodeficiency diseases.

Subject will be infused every 21 to 28 days according to their previous IVIG treatment schedule. Subjects treated every 28 days will receive 13 study IVIG infusions. Subject treated every 21 days will receive 17 study IVIG infusions.

Duration of treatment:The total duration of treatment is 12 months.

Conditions

Immunologic Deficiency Syndrome

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

IVIG-SN™

Immune Globulin Intravenous (Human) 5% Liquid

Group Type: EXPERIMENTAL

Immune Globulin Intravenous (Human) 5% Liquid, IVIG-SN™

Intervention Type: DRUG

IVIG-SN™ 10g/200mL, dose is 300-900 mg/kg/infusion every 21 or 28 days, intravenously. The total duration of treatment with IVIG-SN™ will be 12 months with a 3 month follow-up.

Interventions

Immune Globulin Intravenous (Human) 5% Liquid, IVIG-SN™

IVIG-SN™ 10g/200mL, dose is 300-900 mg/kg/infusion every 21 or 28 days, intravenously. The total duration of treatment with IVIG-SN™ will be 12 months with a 3 month follow-up.

Intervention Type: DRUG

Other Intervention Names

IGIV; Immune Globulin Intravenous (Human) 5% Liquid

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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.

• 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.

• Minimum Eligible Age: 2 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Atlantic Research Group

OTHER

Sponsor Role: collaborator

Green Cross Corporation

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Chaim Roifman, MD

Role: STUDY_CHAIR

The Hospital for Sick Children

Locations

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

Countries

United States; Canada

Other Identifiers

IVIG_SN_P3

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

IVIG_SN_P3

Identifier Type: -

Identifier Source: org_study_id