Overview

Immune Globulin Intravenous (IGIV) For Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)

Status:
Completed
Trial end date:
2006-06-01
Target enrollment:
Participant gender:
Summary
The intent of this study is to demonstrate the efficacy and safety of Immune Globulin Intravenous (Human), 10% Caprylate/Chromatography Purified (IGIV-C) in newly or previously diagnosed CIDP subjects. Eight courses of treatment with either placebo or IGIV-C will occur every 3 weeks. Neurological function will be measured by Inflammatory Neuropathy Cause and Treatment (INCAT) scores. Patients who deteriorate or show no improvement between day 16 and month 6 will receive the alternate study drug for an additional 6 months.
Phase:
Phase 3
Details
Lead Sponsor:
Grifols Therapeutics Inc.
Grifols Therapeutics LLC
Treatments:
Antibodies
gamma-Globulins
Immunoglobulin G
Immunoglobulins
Immunoglobulins, Intravenous
Rho(D) Immune Globulin