Efficacy and Safety Study of Kedrion IVIG 10% to Treat Subjects With Primary Immunodeficiency (PID)
Condition: Primary Immunodeficiency; Agammaglobulinemia; Hypogammaglobulinemia; Antibody Deficiency
MeSH terms: Agammaglobulinemia; Primary Immunodeficiency Diseases; Immunologic Deficiency Syndromes
Intervention: Kedrion IVIG 10%
Intervention description: Dosage form - Intravenous (IV) infusion of Kedrion IVIG 10%; Dosage - 300 to 900 mg/kg body weight (bw); Frequency - every 21 to 28 days; Treatment duration - 12 months
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 45.0
Sex: All
Minimum age: 2 Years
Maximum age: 70 Years
Healthy volunteers: No
Keywords: Primary Immunodeficiency; PID; Agammaglobulinemia; Hypogammaglobulinemia; Antibody deficiency

Summary:

      The purpose of this study is to determine whether Kedrion IVIG 10% (an immunoglobulin
      solution) is effective in treating Primary Immunodeficiency (PID).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Confirmed clinical diagnosis of a Primary Immunodeficiency Disease

          -  Male or female, ages 2 to 70 years

          -  Received 300-900 mg/kg of a licensed IVIG therapy at 21 or 28 day intervals for at
             least 3 months prior to this study

          -  2 documented IgG trough levels of ≥ 5 g/L are obtained at two infusion cycles (21 or
             28 days) within 12 months (one must be within 6 months) prior to study enrolment

          -  Non-pregnant females of child-bearing potential who agree to use adequate birth
             control during the study

          -  Subject is willing to comply with the protocol

          -  Authorization to access personal health information.

          -  Signed the informed consent form and a child assent form, if appropriate.

          -  If 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 Kedrion IVIG 10% and all inclusion and exclusion criteria are
             satisfied

          -  If 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 enrolment in this study

        Exclusion Criteria:

          -  Has secondary immunodeficiency.

          -  Newly diagnosed and has not been treated with immunoglobulin or has been diagnosed
             with dysgammaglobulinemia or isolated IgG subclass deficiency.

          -  Has a history of repeated reactions or hypersensitivity to IVIG or other injectable
             forms of IgG.

          -  Has a history of thrombotic events defined by at least 1 event in subject's lifetime.

          -  Has IgA deficiency and is known to have antibodies to IgA.

          -  Has received blood products other than human albumin or human immunoglobulin within 12
             months prior to enrolment.

          -  Has significant protein losing enteropathy, nephrotic syndrome or lymphangiectasia.

          -  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

          -  Has a known history or is positive at enrolment for human immunodeficiency virus (HIV)
             type 1 by NAT, hepatitis B virus (HBsAg and NAT), hepatitis C virus (by NAT), or
             hepatitis A virus (by NAT).

          -  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.

          -  Has an implanted venous access device

          -  Has profound anemia or persistent severe neutropenia (≤ 1000 neutrophils per mm3)or
             lymphopenia of less than 500 cells per microliter.

          -  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, 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.

          -  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 enrolment.

          -  Has history of epilepsy or multiple episodes of migraine (defined as at least one
             episode within 6 months of enrolment) not completely controlled by medication.

          -  Is receiving steroids (oral or parenteral daily dose of ≥ 0.15 mg/kg/day of prednisone
             or equivalent) OR 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.

          -  Has participated in another clinical study within 3 weeks prior to study enrolment.