Phase III Clinical Trial of NPB-01maintenance Therapy in Patients With Chronic Inflammatory Demyelinating Polyneuropathy.
Status:
Completed
Trial end date:
2015-09-01
Target enrollment:
Participant gender:
Summary
Patients diagnosed with Chronic Inflammatory Demyelinating Polyneuropathy were confirmed
based on the European Federation of Neurological Societies/ Peripheral. Nerve Society
Guideline. Patients who meet all inclusion criteria and do not conflict with the exclusion
criteria will receive NPB-01 (intravenous immunoglobulin) 400mg/kg/day for five consecutive
days. Subsequently, patients receive NPB-01 1g/kg every 3weeks and evaluate the Inflammatory
Neuropathy Cause and Treatment（INCAT） score and INCAT sensory sumscore（ISS） et al.
As a safety endpoint, the safety of NPB-01 will be investigated the occurrence of adverse
events by one year after the start of the study treatment.