At a glance
ClinicalIndex Comparison Record- ✓Documented CIDP diagnosis by experienced neurologist based on progressive/relapsing motor and sensory dysfunction in multiple limbs over ≥2 months, and CSF <50 white cells/µL
- ✓Fulfillment of INCAT neurophysiological criteria for focal demyelinating polyradiculoneuropathy
- ✓Overall INCAT score 2-9 with significant disability in upper or lower limb function in at least 2 limbs
- ✕IGIV or plasma treatment within 3 months prior to entry
- ✕Steroids (Prednisolone or equivalent) >10 mg/day or >20 mg every 2 days during last 3 months
- ✕Immunomodulatory/immunosuppressive agents (azathioprine, tacrolimus, cyclosporine, OKT3, interferons, cyclophosphamide, methotrexate, mitoxantrone) within 6 months; prior lymphoid irradiation
- ✕Fish oil supplements within 30 days prior to entry
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Multicenter, Randomized, Double-blind, Placebo-controlled, Study to Evaluate the Efficacy and Safety of IGIV-Chromatography (IGIV-C), 10% Treatment in Subjects With Chronic Inflammatory Demyelinating Polyneuropathy
In Brief
A Phase 3 clinical trial evaluating Immune Globulin IV (Human), 10% Caprylate/Chromatography Purified and Albumin (Human) 25%, United States Pharmacopeia (USP) for Polyradiculoneuropathy, Chronic Inflammatory Demyelinating. Completed, enrolled 117 participants across 32 sites in 10 countries.
Detailed 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.
Study Details
Timeline
Interventions
2 g/kg body weight ideally over 2-4 days . Thereafter, study drug infusion (IGIV-C) will be administered every 3 weeks at a dose of 1 g/kg bw, given over 1-2 days for a total of 7 additional infusions
Albumin 25%, USP diluted with dextrose 5% to a final concentration of 0.1% as an intravenous infusion. Alternatively, it may be a bottled placebo of 0.1% Albumin (Human) in 0.2 M Glycine, 1.1 mm sodium caprylate, 0.25% sodium chloride. 2 g/kg body weight ideally over 2-4 days . Thereafter, infusion (placebo) will be administered every 3 weeks at a dose of 1 g/kg bw, given over 1-2 days for a total of 7 additional infusions