A Study to Assess the Efficacy and Safety of IGIV-C in Patients With Myasthenia Gravis Exacerbations
Condition: Myasthenia Gravis Exacerbations
MeSH terms: Myasthenia Gravis; Muscle Weakness
Intervention: IGIV-C
Intervention description: An IV dose of 2 g/kg of IGIV-C was administered over 2 consecutive days at a dose of 1 g/kg per day.
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 49.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This was a multicenter, prospective, open-label, non-controlled study to assess the efficacy
      and safety of an IV dose of 2 g/kg of IGIV-C in subjects with MG exacerbations.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Was male or female aged ≥18 years.

          -  Subjects must be willing and able to provide written informed consent (if applicable,
             a legally authorized representative may provide informed consent on behalf of the
             subject).

          -  Subjects who met the clinical criteria for diagnosis of MG with an exacerbation
             defined as worsening of MG symptoms as defined by an Myasthenia Gravis Foundation of
             America (MGFA) classification IVb or V.

          -  Subjects on long-term (8 weeks) corticosteroid treatment for MG.

          -  Female subjects of child-bearing potential must have a negative test for pregnancy
             (human chorionic gonadotropin [HCG]-based assay).

          -  Subjects must be willing to comply with all aspects of the clinical trial protocol,
             including blood sampling and long-term storage of extra samples, for the entire
             duration of the study.

        Exclusion Criteria:

          -  Subjects who had received immune globulin treatment given by IV, subcutaneous or
             intramuscular route within the last 30 days.

          -  Subjects with documentation of a lack of clinical response to intravenous
             immunoglobulin (IVIg) therapy for MG.

          -  Subjects documented positive for antibodies directed against Muscle specific kinase
             (MuSK).

          -  Subjects with corticosteroid (CS) treatment initiated within the last 8 weeks or
             modified within the last 2 weeks.

          -  Subjects with plasma exchange (PLEX) within the last 30 days.

          -  Subjects with MG exacerbation attributable to change in medication or infection or
             evident infection as defined by, but not limited to, the presence of at least one of
             the following diagnostic features: 1) axillary temperature ≥38°C, 2) positive blood
             culture of infective microorganism, 3) white blood cell count >12×10^9/L and
             differential white blood cell count of >10% band neutrophils (>1.2×10^9/L), and 4)
             pulmonary infiltrate with consolidation on chest X-ray. Alternatively, other signs and
             symptoms may be considered for the diagnosis of evident infection according to the
             Investigator's judgement.

          -  Subjects with inadequate venous access.

          -  Subjects with a history of anaphylactic reactions or severe reactions to any
             blood-derived product.

          -  Subjects with a history of intolerance to any component of the investigational
             products.

          -  Subjects with a documented diagnosis of thrombotic complications to polyclonal IVIG
             therapy in the past.

          -  Subjects with a history of recent (within the last year) myocardial infarction, stroke
             or uncontrolled hypertension.

          -  Subjects who suffered from uncontrolled congestive heart failure, embolism or
             documented electrocardiogram (ECG) changes indicative of myocardial ischemia or atrial
             fibrillation.

          -  Subjects with current known hyperviscosity or hypercoagulable state.

          -  Subjects currently receiving anti-coagulation therapy.

          -  Subjects with a history of chronic alcoholism or illicit drug abuse (addiction) in the
             12 months preceding the Baseline Visit.

          -  Subjects currently receiving, or having received within 3 months prior to the Baseline
             Visit, any investigational medicinal product or device.

          -  Subjects with a known Immunoglobulin A (IgA) deficiency and anti-IgA serum antibodies.

          -  Subjects with renal impairment (i.e., serum creatinine exceeds more than 1.5 times the
             upper limit of normal [ULN] for the expected normal range for the testing laboratory).

          -  Subjects with aspartate aminotransferase (AST) or alanine aminotransferase (ALT)
             levels exceeding more than 2.5 times the ULN for the expected normal range for the
             testing laboratory.

          -  Subjects with haemoglobin levels <9 g/dL.