drugset / Trial / NCT01225276

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

NCT01225276

Phase 2/3 Terminated 2 enrolled Octapharma
RandomizedParallel-groupDouble-blindTreatment

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.

Timeline

Start
2011-10
Primary completion
2012-10
Completion
2012-10

Drugs

EvaluationDrugModalityDoseRoute
Subject Immune Globulin Intravenous (Human) Protein / enzyme biologic 0.4 g/kg Intravenous
Subject Immune Globulin Intravenous (Human) Protein / enzyme biologic 1 g/kg Intravenous
Subject Immune Globulin Intravenous (Human) Protein / enzyme biologic 2 g/kg Intravenous