A Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of Immune Globulin (Human) 10% (Gamunex-C) PEG Process (IVIG-PEG) Compared to Gamunex-C in Participants With Primary Humoral Immunodeficiency
Condition: Primary Immunodeficiency
MeSH terms: Primary Immunodeficiency Diseases; Immunologic Deficiency Syndromes
Intervention: Gamunex-C; IVIG-PEG
Intervention description: Intravenous infusion.; Intravenous infusion.
Intervention MeSH terms: Immunoglobulins, Intravenous
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Sequential Assignment
Intervention model description: The study model for this is Single-Sequence crossover.
Masking: None (Open Label)
Enrollment: 33.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to demonstrate bioequivalence of IVIG-PEG with Gamunex-C
      (IVIG-C) at steady-state as determined by comparing total Immunoglobulin G (IgG) area under
      the concentration-time curve during the defined dosing interval ([AUC0-τ] either every 3
      weeks [AUC0-21 days] or every 4 weeks [AUC0-28 days]) and maximum concentration in a dosing
      interval (Cmax) in participants diagnosed with primary humoral immunodeficiency (PI)
      currently receiving chronic IVIG replacement treatment.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female between 18 and 75 years of age (inclusive) at Screening

          -  Documented and confirmed pre-existing diagnosis of PI with features of
             hypogammaglobulinemia requiring IV IgG replacement therapy including but not limited
             to the following humoral-based immunodeficiency syndromes (example, X-linked
             agammaglobulinemia, common variable immunodeficiency), and combined immunodeficiency
             syndromes without lymphocytopenia (example, hyper immunoglobulin M [IgM]
             immunodeficiency syndrome).

          -  IgG trough level ≥500 milligrams per deciliter (mg/dL) at screening visit. Note:
             Patients entering Group 1 must additionally have trough levels ≥500 mg/dL documented
             within the previous year. For patients entering Group 2, if Screening trough levels
             are not ≥500 mg/dL, the subject will be a Screen Failure, but may be rescreened
             following dose adjustment of their original IV IgG replacement therapy regimen and
             recording an IgG trough level ≥500 mg/dL

          -  Has not had an SBI within the last 6 months prior to screening or during the
             screening.

          -  Medical records are available to document diagnosis, previous infections, and
             treatment.

          -  Willing to comply with all aspects of the study protocol, including blood sampling,
             for the duration of the study.

          -  Signed and dated a written informed consent form (ICF) confirming his or her
             willingness to participate in study GC1902.

        Exclusion Criteria:

          -  Has an acquired medical condition that is known to cause secondary immune deficiency
             such as chronic lymphocytic leukemia, lymphoma, multiple myeloma, chronic or recurrent
             neutropenia (absolute neutrophil count less than 1000per microliters (1000/μL) [1.0 x
             10^9/L]), or human immunodeficiency virus (HIV) infection/acquired immune deficiency
             syndrome (AIDS).

          -  Has known selective Immunoglobulin A (IgA) deficiency (with or without antibodies to
             IgA). (Note: exclusion is for the specific diagnostic entity. It does not exclude
             other forms of primary humoral immunodeficiency which have decreased IgA in addition
             to decreased IgG requiring IgG replacement).

          -  Has isolated IgG subclass deficiency or an isolated specific antibody deficiency
             disorder, or transient hypogammaglobulinemia of infancy

          -  The subject has had a known serious adverse reaction to immunoglobulin or any severe
             anaphylactic reaction to blood or any blood-derived product.

          -  Has a history of thrombotic complications following IVIG therapy.

          -  Has a history of or current diagnosis of deep venous thrombosis (DVT) or
             thromboembolism (e.g., myocardial infarction, cerebrovascular accident or transient
             ischemic attack); history refers to an incident in the year prior to the Screening
             Visit or 2 episodes over lifetime or has thrombosis risk factors (e.g., prolonged
             immobilization, use of estrogens, indwelling central vascular catheters).

          -  Has a known hyperviscosity syndrome or hypercoagulable states.

          -  Has liver enzyme levels (alanine aminotransferase [ALT], aspartate aminotransferase
             [AST], gammaglutamyl transferase [GGT], or lactate dehydrogenase [LDH]) greater than
             2.5 times the upper limit of normal (ULN) at the screening visit as defined by the
             testing laboratory.

          -  Has pre-existing renal impairment (defined by serum creatinine greater than 1.5 times
             the ULN or blood urea nitrogen [BUN] greater than 2.5 times the ULN, or any subject
             who is on dialysis) at the screening visit or any history of acute renal injury.

          -  Has clinically significant history of drug or alcohol abuse or dependence in the
             opinion of the Investigator (must be within the past 12 months and noted in the
             subject's medical records or documented at screening).

          -  Clinical evidence of any significant acute or chronic medical condition (e.g., renal
             disease or predisposing conditions for renal disease, coronary artery disease, or
             protein losing state) that, in the opinion of the Investigator, may interfere with the
             conduct of the study or may place the subject at undue medical risk.

          -  Females of childbearing potential who are pregnant, have a positive pregnancy test at
             Screening (human chorionic gonadotropin [HCG]-based assay), are breastfeeding, or
             unwilling to practice a highly effective method of contraception (eg, oral, injectable
             or implanted hormonal methods of contraception, placement of an intrauterine device
             [IUD] or intrauterine system [IUS], condom or occlusive cap with spermicidal
             foam/gel/film/cream/suppository, male sterilization, or true abstinence) throughout
             the study. Note: True abstinence: When this is in line with the preferred and usual
             lifestyle of the subject. (Periodic abstinence [e.g., calendar, ovulation,
             symptothermal, postovulation methods], declaration of abstinence for the duration of a
             trial, and withdrawal are not acceptable methods of contraception).

          -  Receiving any of the following medications: (a) immunosuppressants including
             chemotherapeutic agents, (b) immunomodulators, (c) long-term systemic corticosteroids
             defined as daily dose >1 mg of prednisone equivalent/kg/day for >30 days. Note:
             Intermittent courses not exceeding >1mg of prednisone equivalent/kg/day for >30 days
             would not exclude the subject. Inhaled or topical corticosteroids are allowed.

          -  Has uncontrolled arterial hypertension (systolic blood pressure [SBP] >160 mm Hg
             and/or diastolic blood pressure [DBP] >100 mm Hg)

          -  Has hemoglobin <11 g/dL at the Screening Visit

          -  Unable or unwilling to provide a storage serum sample at the Screening Visit. Note: A
             pre-treatment serum sample to be stored at -94°F (-70ºC) for possible future testing
             is required.

          -  Received any live virus vaccine within 5 months prior to the Screening Visit and not
             willing to postpone receiving any live virus vaccines until 6 months after completing
             study treatment

          -  Has a known previous infection with or clinical signs and symptoms consistent with
             current hepatitis B virus (HBV) or hepatitis C virus (HCV) infection

          -  Has participated in another clinical trial within 30 days prior to Screening or has
             received any investigational product, with the exception of other IgG products, within
             the previous 3 months prior to the Screening Visit