A Study to Assess the Efficacy and Safety of IGIV-C in Patients With Myasthenia Gravis Exacerbations

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 thesubject).

• Subjects who met the clinical criteria for diagnosis of MG with an exacerbationdefined as worsening of MG symptoms as defined by an Myasthenia Gravis Foundation ofAmerica (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 entireduration of the study.

Exclusion Criteria:

• Subjects who had received immune globulin treatment given by IV, subcutaneous orintramuscular route within the last 30 days.

• Subjects with documentation of a lack of clinical response to intravenousimmunoglobulin (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 ormodified 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 orevident infection as defined by, but not limited to, the presence of at least one ofthe following diagnostic features: 1) axillary temperature ≥38°C, 2) positive bloodculture of infective microorganism, 3) white blood cell count >12×10^9/L anddifferential 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 andsymptoms may be considered for the diagnosis of evident infection according to theInvestigator's judgement.

• Subjects with inadequate venous access.

• Subjects with a history of anaphylactic reactions or severe reactions to anyblood-derived product.

• Subjects with a history of intolerance to any component of the investigationalproducts.

• Subjects with a documented diagnosis of thrombotic complications to polyclonal IVIGtherapy in the past.

• Subjects with a history of recent (within the last year) myocardial infarction, strokeor uncontrolled hypertension.

• Subjects who suffered from uncontrolled congestive heart failure, embolism ordocumented electrocardiogram (ECG) changes indicative of myocardial ischemia or atrialfibrillation.

• 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 BaselineVisit, 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 theupper 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 thetesting laboratory.

• Subjects with haemoglobin levels <9 g/dL.