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

This study has been completed.
Sponsor:
Collaborator:
Atlantic Research Group
Information provided by (Responsible Party):
Green Cross Corporation
ClinicalTrials.gov Identifier:
NCT01406470
First received: July 26, 2011
Last updated: January 9, 2014
Last verified: January 2014
  Purpose

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.


Condition Intervention Phase
Immunologic Deficiency Syndrome
Drug: Immune Globulin Intravenous (Human) 5% Liquid, IVIG-SN™
Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Green Cross Corporation:

Primary Outcome Measures:
  • Incidence of acute serious bacterial infections [ Time Frame: one year ] [ Designated as safety issue: No ]
  • Overall incidence of adverse events that occur during or within 1 hour, 24 hours and 72 hours following an infusion of test product [ Time Frame: Within 72 hours after treatment with IVIG-SN ] [ Designated as safety issue: Yes ]
  • The Pharmacokinetic (PK) Area under the curve (AUC0-t, AUC0-inf) of Immunoglobulin G (IgG). [ Time Frame: After 5th infusion ] [ Designated as safety issue: No ]
  • The Pharmacokinetic (PK) Maximum concentration (Cmax) of Immunoglobulin G (IgG). [ Time Frame: After 5th infusion ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • The number of days missed work/school/kindergarten/day care or unable to perform normal daily activities due to infection. [ Time Frame: one year ] [ Designated as safety issue: No ]
  • Days of unscheduled physician visits and hospitalizations due to infection [ Time Frame: One year ] [ Designated as safety issue: No ]
  • Number of days on therapeutic antibiotics [ Time Frame: One year ] [ Designated as safety issue: No ]
  • The incidence of infections other than acute serious bacterial infections [ Time Frame: One year ] [ Designated as safety issue: No ]
  • Annual rate of fever episodes per patient [ Time Frame: One year ] [ Designated as safety issue: No ]
  • All adverse events regardless of causality assessment by investigator [ Time Frame: One year ] [ Designated as safety issue: Yes ]
  • The proportion and number of IGIV infusions for which the infusion rate was decreased due to adverse events [ Time Frame: One year ] [ Designated as safety issue: Yes ]
  • The proportion of adverse events considered by the investigator to be product related [ Time Frame: One year ] [ Designated as safety issue: Yes ]
  • To monitor viral safety (freedom from transmission of blood borne virus diseases) [ Time Frame: One year ] [ Designated as safety issue: Yes ]
  • Descriptive analyses of PK parameters for specific antibodies (anti-Hemophilus influenza type b, anti-Streptococcus pneumonia serotypes, anti-Tetanus toxoid, anti-cytomegalovirus (CMV), anti-measles) will be performed. [ Time Frame: One year ] [ Designated as safety issue: No ]

Enrollment: 45
Study Start Date: September 2011
Study Completion Date: July 2013
Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: IVIG-SN™
Immune Globulin Intravenous (Human) 5% Liquid
Drug: 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.
Other Names:
  • IGIV
  • Immune Globulin Intravenous (Human) 5% Liquid

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.

  Eligibility

Ages Eligible for Study:   2 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  • 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.

Exclusion Criteria:

  • 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01406470

Locations
United States, Alabama
University of Alabama Hospital
Birmingham, Alabama, United States, 35233
United States, Florida
Allergy Associates of the Palm Beaches
North Palm Beach, Florida, United States, 33408
United States, Illinois
Rush University Medical Center
Chicago, Illinois, United States, 33408
United States, Iowa
University of Iowa Hospitals and Clinics
Iowa City, Iowa, United States, 52242
United States, Ohio
Optimed Research, LTD
Columbus, Ohio, United States, 43235
United States, Texas
AARA Research Center
Dallas, Texas, United States, 75231
Dallas Allergy Immunology
Dallas, Texas, United States, 75230
United States, Virginia
Children's Hospital of Richmond
Richmond, Virginia, United States, 23219
United States, Washington
Bellingham Asthma, Allergy & Immunology Clinic
Bellingham, Washington, United States, 98225
Canada, Ontario
The Hospital for Sick Children
Toronto, Ontario, Canada, M5G1X8
Gordon Sussman Clinical Research Inc.
Toronto, Ontario, Canada, M4V1R2
Sponsors and Collaborators
Green Cross Corporation
Atlantic Research Group
Investigators
Study Chair: Chaim Roifman, MD The Hospital for Sick Children
  More Information

No publications provided

Responsible Party: Green Cross Corporation
ClinicalTrials.gov Identifier: NCT01406470     History of Changes
Other Study ID Numbers: IVIG_SN_P3, IVIG_SN_P3
Study First Received: July 26, 2011
Last Updated: January 9, 2014
Health Authority: United States: Food and Drug Administration
Canada: Health Canada

Keywords provided by Green Cross Corporation:
IGIV
Primary Immune Deficiency
Immunoglobulin G

Additional relevant MeSH terms:
Immunologic Deficiency Syndromes
Immune System Diseases
Antibodies
Immunoglobulins
Immunoglobulins, Intravenous
Rho(D) Immune Globulin
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 28, 2014