A Study Investigating Intravenous Human Normal Immunoglobulin 10% in Adults With Chronic Immune Thrombocytopenia (ITP)

Exclusion Criteria36

• Patients with secondary ITP (all forms of immune-mediated thrombocytopenia except primary ITP). e.g., lupus erythematosus, rheumatoid arthritis, drug-related ITP, and Human Immunodeficiency Virus (HIV).
• Patients with Evans Syndrome.
• Patients known to be infected with hepatitis B virus, hepatitis C virus, or HIV.
• History of thrombotic events including deep vein thrombosis, cerebrovascular accident, pulmonary embolism, transient ischemic attacks, or myocardial infarction.
• Patient with a history of hypersensitivity to IVIg, other injectable forms of IVIg, or to any of the excipients.
• Patient unresponsive previously to IVIg or anti-D Ig treatment.
• Patient with known Immunoglobulin A (IgA) deficiency and antibodies against IgA.
• Splenectomy within 4 weeks of the Baseline Visit or planned splenectomy throughout the study period.
• Subjects with known inherited thrombocytopenia. e.g., MYH-9 disorders.
• Subjects with myelodysplastic syndrome (MDS).
• Administration of IVIg, anti-D immunoglobulin, mercaptopurine, vinca alkaloid, or platelet enhancing drugs (including thrombopoietin receptor agonists \[TPO-RA\], immunosuppressive, or other immunomodulatory drugs) within 3 weeks of the Baseline Visit, except for:
• patients on a stable dose of TPO-RA within 4 weeks of the Baseline Visit
• patients on a stable dose of Mycophenolate Mofetil within 3 months of the Baseline Visit
• patients on stable dose of Danazol within 3 months of the Baseline Visit
• long-term corticosteroid therapy for ITP, when the dose had been stable within 3 weeks of the Baseline Visit and no dosage change was planned until the EOS Visit
• long-term azathioprine cyclophosphamide or attenuated androgen therapy when the dose had been stable within 3 months of the Baseline Visit, and no dosage change was planned until after study completion.
• Received any blood, blood product, or blood derivative within 1 month of the Baseline Visit.
• Received rituximab within 6 months of the Baseline Visit.
• Had a platelet transfusion or receipt of blood products containing platelets within 7 days of Visit 1 (Day 1).
• Received recombinant activated factor VII within 7 days of the Baseline Visit.
• Had therapy with live attenuated virus vaccines within 3 months of the Baseline Visit.
• Use of loop diuretics within 1 week of the Baseline Visit.
• Patients at high risk of thrombotic events.
• Uncontrolled hypertension \[i.e., diastolic blood pressure \>100 mmHg and/or systolic blood pressure \>160 mmHg\]. If a single measure exceeds this limit, a triple repeat measurement may be performed and the average of the three measurements used.
• Congestive heart failure as per New York Heart Association III/IV, cardiomyopathy, cardiac arrhythmia associated with thromboembolic events (e.g., atrial fibrillation), unstable or advanced ischemic heart disease, hyperviscosity.
• Patients with significant protein losing enteropathy, nephrotic syndrome, or lymphangiectasia.
• Patients with hyperproteinemia, increased serum viscosity, and/or hyponatremia.
• Severe liver or kidney disease (normal reference ranges of laboratory doing the analysis):
• alanine aminotransferase (ALT) or aspartate amino transferase (AST) 2.5x \> upper limit of normal
• creatinine \> 120 μmol/L
• blood urea nitrogen (BUN) \> 2.5x the upper limit of normal.
• Signs of severe anemia: Hemoglobin of less than 7 g/dL, hemodynamically unstable due to active bleeding, and/or when evidence of end-organ ischemia secondary to severe anemia is present.
• Body mass index \> 40 kg/m2 or an IVIg dose that puts the patient at risk of fluid overload.
• History of a malignant disease within 3 years of the Baseline Visit other than properly treated carcinoma in situ of the cervix or basal cell or squamous cell carcinoma of the skin.
• Patient has participated in an interventional, investigational clinical study within 30 days of the Baseline Visit.
• Any condition that the Investigator believes is likely to interfere with evaluation of the study drug or with satisfactory conduct of the trial.