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

NCT01406470 | Completed Phase 3 DMC

• 1 other identifier: IVIG_SN_P3
• Study Type: interventional
• Target: 45
• Locations: 2 countries
• Sites: 11

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.

Conditions

Immunologic Deficiency Syndrome

Keywords

IGIV; Primary Immune Deficiency; Immunoglobulin G

Outcome Measures

Primary Outcomes (4)

• Incidence of acute serious bacterial infections

  one year

• Overall incidence of adverse events that occur during or within 1 hour, 24 hours and 72 hours following an infusion of test product

  Within 72 hours after treatment with IVIG-SN

• The Pharmacokinetic (PK) Area under the curve (AUC0-t, AUC0-inf) of Immunoglobulin G (IgG).

  After 5th infusion

• The Pharmacokinetic (PK) Maximum concentration (Cmax) of Immunoglobulin G (IgG).

  After 5th infusion

Secondary Outcomes (10)

• The number of days missed work/school/kindergarten/day care or unable to perform normal daily activities due to infection.

  one year

• Days of unscheduled physician visits and hospitalizations due to infection

  One year

• Number of days on therapeutic antibiotics

  One year

• The incidence of infections other than acute serious bacterial infections

  One year

• Annual rate of fever episodes per patient

  One year

Study Arms (1)

IVIG-SN™

EXPERIMENTAL

Immune Globulin Intravenous (Human) 5% Liquid

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

Interventions

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

Also known as: IGIV, Immune Globulin Intravenous (Human) 5% Liquid

IVIG-SN™

Eligibility Criteria

• Age: 2 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Green Cross Corporation: lead
• Atlantic Research Group: collaborator

Study Sites (11)

University of Alabama Hospital

Birmingham, Alabama, 35233, United States

Location

Allergy Associates of the Palm Beaches

North Palm Beach, Florida, 33408, United States

Location

Rush University Medical Center

Chicago, Illinois, 33408, United States

Location

University of Iowa Hospitals and Clinics

Iowa City, Iowa, 52242, United States

Location

Optimed Research, LTD

Columbus, Ohio, 43235, United States

Location

Dallas Allergy Immunology

Dallas, Texas, 75230, United States

Location

AARA Research Center

Dallas, Texas, 75231, United States

Location

Children's Hospital of Richmond

Richmond, Virginia, 23219, United States

Location

Bellingham Asthma, Allergy & Immunology Clinic

Bellingham, Washington, 98225, United States

Location

Gordon Sussman Clinical Research Inc.

Toronto, Ontario, M4V1R2, Canada

Location

The Hospital for Sick Children

Toronto, Ontario, M5G1X8, Canada

Location

MeSH Terms

Conditions

Immunologic Deficiency Syndromes; Primary Immunodeficiency Diseases

Interventions

gamma-Globulins; Fluid Therapy

Condition Hierarchy (Ancestors)

Immune System Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Drug Therapy; Therapeutics

Study Officials

• Chaim Roifman, MD

  The Hospital for Sick Children

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 26, 2011
• First Posted: August 1, 2011
• Study Start: September 1, 2011
• Primary Completion: July 1, 2013
• Study Completion: July 1, 2013
• Last Updated: January 10, 2014

Record last verified: 2014-01

Locations

US (9); CA (2)