Safety and Efficacy Study of Three Different Dosages of NewGam in Patients With CIDP

• Status: Terminated
• Trial end date: 2012-10-01
• Target enrollment: 0
• Participant gender: All

Summary

NewGam (current working title for a new IGIV formulation) is a newly developed human normal immunoglobulin solution ready for intravenous administration (IGIV). This study will evaluate the safety and efficacy of three different dosages of NewGam 10% in patients with Chronic Inflammatory Demyelinating Polyradiculoneuropathy.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Octapharma

Criteria

Inclusion Criteria:

• Patients diagnosed as having CIDP based on fulfilment of clinical criteria of the INCAT Group and the definite electrophysiological criteria for CIDP ; patients with MADSAM or pure motor CIDP will be included provided they fulfil these criteria

• Worsening of disability and objective increase in weakness or sensory deficit during the 6 months prior to screening

• >=18 years of age

Exclusion Criteria:

• Unifocal forms of CIDP

• Pure sensory CIDP

• MMN with conduction block

• Treatment of CIDP with immunoglobulins (intravenous or subcutaneous) at any time prior to study entry

• Steroids of any type equivalent to prednisolone or prednisone > 10 mg/day or equivalent plasma exchange (PE) during the last 3 months prior to baseline visit

• Treatment with cyclosporin, methotrexate, mitoxantrone, mycophenolate mofetil, interferon or other immunosuppressive or immunomodulatory drugs during the three months prior to baseline visit

• Clinical evidence of peripheral neuropathy from another

• Known diabetes mellitus

• Other serious medical condition complicating assessment or treatment

• Thromboembolic events: patients with a history of deep vein thrombosis (DVT) within the last year prior to baseline visit or pulmonary embolism ever

• Known IgA deficiency with antibodies to IgA

• History of hypersensitivity, anaphylaxis or severe systemic response to immunoglobulin, blood or plasma derived products, or any component of NewGam

• Known blood hyperviscosity