NCT01824251

Phase III Clinical Trial of NPB-01maintenance Therapy in Patients With Chronic Inflammatory Demyelinating Polyneuropathy.

NPB-01(Intravenous Immunoglobulin) Maintenance Therapy for Patients With Chronic Inflammatory Demyelinating Polyneuropathy.

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 49 (actual)
• Sponsor: Nihon Pharmaceutical Co., Ltd · Industry
• Sex: All
• Age: 20 Years – 100 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Chronic Inflammatory Demyelinating Polyneuropathy

Interventions

Type	Name	Description
DRUG	NPB-01

Timeline

• Start date: 2013-04-01
• Primary completion: 2015-09-01
• Completion: 2015-09-01
• First posted: 2013-04-04
• Last updated: 2016-01-20

Locations

1 site across 1 country: Japan