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

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT01406470
• Date of registration: 26/07/2011
• Prospective Registration: Yes
• Primary sponsor: Green Cross Corporation
• Public title: Phase 3 Study of Immune Globulin Intravenous (Human)IVIG-SN™ in Subjects With Primary Immunodeficiency
• Scientific 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
• Date of first enrolment: September 2011
• Target sample size: 45
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT01406470
• Study type: Interventional
• Study design: Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
• Phase: Phase 3

Countries of recruitment

Canada, United States

Contacts

• Name: Chaim Roifman, MD
• Affiliation: The Hospital for Sick Children

Key inclusion & exclusion 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.



Age minimum: 2 Years
Age maximum: 70 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Immunologic Deficiency Syndrome

Intervention(s)

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

Primary Outcome(s)

The Pharmacokinetic (PK) Area under the curve (AUC0-t, AUC0-inf) of Immunoglobulin G (IgG). [Time Frame: After 5th infusion]

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]

The Pharmacokinetic (PK) Maximum concentration (Cmax) of Immunoglobulin G (IgG). [Time Frame: After 5th infusion]

Incidence of acute serious bacterial infections [Time Frame: one year]

Secondary Outcome(s)

Number of days on therapeutic antibiotics [Time Frame: One year]

The proportion and number of IGIV infusions for which the infusion rate was decreased due to adverse events [Time Frame: One year]

Annual rate of fever episodes per patient [Time Frame: One year]

To monitor viral safety (freedom from transmission of blood borne virus diseases) [Time Frame: One year]

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]

All adverse events regardless of causality assessment by investigator [Time Frame: One year]

Days of unscheduled physician visits and hospitalizations due to infection [Time Frame: One year]

The incidence of infections other than acute serious bacterial infections [Time Frame: One year]

The number of days missed work/school/kindergarten/day care or unable to perform normal daily activities due to infection. [Time Frame: one year]

The proportion of adverse events considered by the investigator to be product related [Time Frame: One year]

Secondary ID(s)

IVIG_SN_P3

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Atlantic Research Group