Study to Evaluate Safety and Efficacy of Three Different Dosages of NewGam in Patients With Chronic Inflammatory Demyelinating Poly (Radiculo) Neuropathy

Exclusion Criteria

• •1. Unifocal forms of Chronic inflammatory demyelinating polyneuropathy (CIDP)
• •2. Pure sensory Chronic inflammatory demyelinating polyneuropathy (CIDP)
• •3. Multifocal motor neuropathy (MMN) with conduction block \[van den Bergh et al., 2010\]
• •4. Patients who previously failed immunoglobulin treatment
• •5. Treatment with immunomodulatory/suppressive agents (cyclosporin, methotrexate, mitoxantrone, mycophenolate mofetil or azathioprine) during the six months prior to baseline visit
• •6. Patients on or treated with rituximab, alemtuzumab, cyclophosphamide, or other intensive chemotherapeutic regimens, previous lymphoid irradiation or stem cell transplantation during the 12 months prior to baseline visit
• •7. Respiratory impairment requiring mechanical ventilation
• •8. Myelopathy or evidence of central nervous system demyelination or significant persisting neurological deficits from stroke, or central nervous system (CNS) trauma
• •9. Clinical evidence of peripheral neuropathy from another cause such as
• •1. connective tissue disease or systemic lupus erythematosus (SLE)
• •2. HIV infection, hepatitis, Lyme disease
• •3. cancer (with the exception of basal cell skin cancer)
• •4. IgM paraproteinemia with anti-myelin associated glycoprotein antibodies
• •10. Diabetic neuropathy
• •11. Cardiac insufficiency (New York Heart Association \[NYHA\] III/IV), cardiomyopathy, significant cardiac dysrhythmia requiring treatment, unstable or advanced ischemic heart disease
• •12. Severe liver disease (ALAT 3x \> normal value)
• •13. Severe kidney disease (creatinine 1.5x \> normal value)
• •14. Hepatitis B, hepatitis C or HIV infection
• •15. Thromboembolic events: patients with a history of deep vein thrombosis (DVT) within the last year prior to baseline visit or pulmonary embolism ever; patients with susceptibility to embolism or deep vein thrombosis (DVT)
• •16. Body mass index (BMI) ≥40 kg/m2
• •17. Patients with uncompensated hypothyroidism (abnormally high Thyroid-Stimulating Hormone \[TSH\] and abnormally low Thyroxine \[T4\]) or known vitamin B12 deficiency if patients don't receive adequate substitution therapy
• •18. Medical conditions whose symptoms and effects could alter protein catabolism and/or Immunoglobulin G (IgG) utilization (e.g. protein-losing enteropathies, nephrotic syndrome)
• •19. Known Immunoglobulin A (IgA) deficiency with antibodies to Immunoglobulin A (IgA)
• •20. History of severe hypersensitivity, e.g. anaphylaxis or severe systemic response to immuno-globulin, blood or plasma derived products, or any component of NewGam
• •21. Known blood hyperviscosity, or other hypercoagulable states
• •22. Use of other blood or plasma-derived products within three months prior to Visit 2
• •23. Patients with a past or present history of drug abuse or alcohol abuse within the preceding five years prior to baseline visit
• •24. Patients unable or unwilling to understand or comply with the study protocol
• •25. Participation in another interventional clinical study with investigational medicinal product (IMP) treatment currently or during the three months prior to Visit 2
• •26. Women who are breast feeding, pregnant, or planning to become pregnant, or are unwilling to use an effective birth control method (such as implants, injectables, combined oral contraceptives, some intrauterine devices (IUDs), sexual abstinence or vasectomized partner) while on study