Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as Intravenous Immune Globulin, Immune Globulin Intravenous (Human)
Immune Globulin · 7 trials · 10 indications
The primary efficacy objective was the comparison of IGIV-C and Placebo group Responder rates. An Efficacy Period Responder was defined as a subject with ≥ 1 point improvement in the adjusted Inflammatory Neuropathy Case And Treatment (INCAT) score, with the improvement maintained through the end of Week 24 in the Efficacy Period. Measurements are reported in INCAT scale of 0-5 in both lower and upper extremities, for a total score of 0 to 10. INCAT scores for arm disability: 0 = no upper limb problems; 5 = inability to use either arm for any purposeful movement. INCAT scores for leg disability: 0= walking not affected; 5 = restricted to wheelchair, unable to stand and walk a few steps with help
Geometric least-squares mean of steady-state plasma concentration of total IgG vs. time profile (AUC).
Using the LogMAR score, lower values correspond to higher visual acuity. For example, a visual acuity of 20/20 corresponds to a LogMAR value of zero (0), and a visual acuity of 20/100 corresponds to a LogMAR value of 0.7.
Free hemoglobin as a measure to assess hemolysis.
Hematocrit as a measure to assess hemolysis
Red blood cells as a measure to assess hemolysis
A relapse was defined for the purposes of this study as the appearance or reappearance of one or more neurological symptoms or worsening of an old symptom attributed to multiple sclerosis (MS) persisting for at least 48 hours and immediately preceded by a relatively stable or improving neurological state of at least 30 days.
| Arm | Type | Description |
|---|---|---|
| Group 1 | EXPERIMENTAL | IGIV-C |
| Group 2 | PLACEBO_COMPARATOR | - |
| Intravenous Immune Globulin + Standard Medical Treatment | EXPERIMENTAL | Participants will receive the first intravenous (IV) infusion of IVIG on Day 1 up to a net dose of 2 gram per kilogram (g/kg), based upon participant's (body weight) administered in divided doses as infusions of 500 milligram per kilogram (mg/kg), based upon participant's body weight, over 4 days or 400 mg/kg, based upon participant's body weight, over 5 days. Participants will also receive all standard of care interventions while hospitalized, from Day 1 to Day 29. |
| Standard Medical Treatment | ACTIVE_COMPARATOR | Participants will receive all standard of care interventions required throughout the participant's hospitalization, from Day 1 to Day 29 |
| Immune Globulin Intravenous (Human) | EXPERIMENTAL | Immune Globulin Intravenous (Human), 10%, Caprylate/Chromatography Purified |
| Group 3 | PLACEBO_COMPARATOR | placebo (0.1% albumin) 4 ml/kg bw/infusion |
| Name | Type | Description |
|---|---|---|
| Immune Globulin IV (Human), 10% Caprylate/Chromatography Purified | DRUG | 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 (Human) 25%, United States Pharmacopeia (USP) | DRUG | 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 |
| Immune Globulin Intravenous [Human], 10% Caprylate/Chromatography Purified | DRUG | - |
| Dextrose, 5% in Water | DRUG | - |
| Intravenous Immune Globulin | BIOLOGICAL | IVIG Intravenous infusion |
| Standard Medical Treatment | DRUG | SMT |
| Immune Globulin Intravenous (Human) | BIOLOGICAL | This trial was an open-label, single-sequence, study. The enrolled subjects received IGIV-C via two routes of administration (IV for 4 -5 weeks and SC for 24 weeks) in order to compare the PK variables, safety and tolerability of SC administration of IGIV-C. Certain subjects required IV IGIV-C dosing during a Run-in Phase (3 - 4 months) for steady-state conditions prior to the IV phase. Subjects received two IV infusions of IGIV (between 200 - 600 mg based on the subject's previous IgG dosing regimen, 3 to 4 weeks apart) until a steady-state was reached at which time PK profiling was performed. Subjects began weekly SC administration (1.37 times the weekly equivalency of each subject's monthly IV dose) 1 week following last IV dose and followed for a period of six months. |
| Immune Globulin IV [Human], 10% Caprylate/Chromatography Purified | DRUG | IGIV-C 10% at a dose of 1.0g/kg was to be given on 2 occasions as a single daily infusion: Group 1 were to receive their first IGIV-C, 10-% infusion at a rate of 0.08 mL/kg/min and a second infusion at 0.14 mL/kg/min. and Group 2 were to receive their first IGIV-C, 10-% infusion at a rate of 0.14 mL/kg/min and a second infusion at a rate of 0.08 mL/kg/min. |
Inclusion Criteria: * Documented diagnosis of CIDP must be made by a neurologist specializing/experienced in neuromuscular diseases based on: a) Progressive or relapsing motor and sensory dysfunction of more than one limb resulting from neuropathy over the 2 months prior to the date informed consen...
Immune Globulin is being studied in several conditions, including COVID-19, immunologic deficiency syndrome, age-related macular degeneration, relapsing-remitting multiple sclerosis, chronic inflammatory demyelinating polyradiculoneuropathy, and idiopathic thrombocytopenic purpura. It is an investigational therapy and has not been approved for these uses.
Immune Globulin is developed by Grifols, S.A., which trades under the ticker GRFS. Grifols is a global healthcare company focused on plasma-derived medicines and transfusion medicine.
Immune Globulin is in Phase 2 clinical development. The program includes completed Phase 2 trials in COVID-19 and immunologic deficiency syndrome, with additional completed Phase 2 studies in macular degeneration and relapsing-remitting multiple sclerosis.
Immune Globulin has been evaluated in completed Phase 2 trials, including NCT04432324 in hospitalized COVID-19 patients, NCT00389324 in primary immunodeficiency, NCT00220805 in age-related macular degeneration, and NCT00220779 in relapsing-remitting multiple sclerosis. No active trials are currently listed.
Yes, Immune Globulin is also known as intravenous immune globulin, immune globulin IV [human], and immune globulin intravenous (human). The 10% caprylate/chromatography purified formulation is one specific version of this product.