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IGIV-C 10%

Phase 3

Primary Immunodeficiency | Monoclonal antibody | Immunology |Grifols, S.A.|Last Updated: Oct 4, 2019

Success Probability

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Market & Valuation

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Trial Design

ACTIVE_CONTROLLED
Total Trials1
Total Enrollment53

FDA Designations

No designations recorded

Clinical trial landscape

IGIV-C 10% · 1 trial · 1 indication

Phase 3 1
NCT02604810Safety and Pharmacokinetics of IGSC 20% in Subjects With Primary ImmunodeficiencyPrimary Immunodeficiency
COMPLETED53 Analytics
PHASE3COMPLETED
Safety and Pharmacokinetics of IGSC 20% in Subjects With Primary Immunodeficiency
Primary Immunodeficiency
NCT0260481053
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Study Endpoints

Primary Endpoints

AUC in the IV Phase and SC Phases: Steady-state AUC of Total IgG Over a Regular Dosing Interval
For intravenous infusion, predose, 0,1,3-16 hours and 1,2,3,5,7,14,21 or 28 days (2, 7, 21, or 28 days for pediatric subjects) post-dose and for subcutaneous infusion, pre-dose,1,3,4,5,7 days (3 and 7 days for pediatric subjects) post-dose

The primary PK endpoint (steady-state AUC values) analysis was performed using analysis of variance (ANOVA) using PK data from a total of 49 subjects from the IV phase and 39 subjects from the SC phase.

Secondary Endpoints

Mean Steady-state Trough (Pre-dose) Concentration of Total IgG Following IV Administration of IGIV-C 10% or SC Administration of IGSC 20%
For intravenous infusion, pre-dose at Week 1 and Week 3 or Week 4 and for subcutaneous infusion, predose at Weeks 13, 14, 17, and 21
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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelSEQUENTIAL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
IGIV-C 10%ACTIVE_COMPARATORIV dose of Immune Globulin Injection (Human), 10% Caprylate/Chromatography Purified (Grifols)
IGSC 20%EXPERIMENTALImmune Globulin Subcutaneous (Human), 20% Caprylate/Chromatography Purified (Grifols)

Interventions

NameTypeDescription
IGIV-C 10%BIOLOGICALIGIV-C 10% infusions every 3 to 4 weeks based on previous IgG regimen
IGSC 20%BIOLOGICALIGSC 20% weekly infusions with dose calculated based on previous IgG regimen
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Eligibility Criteria

Age Range2 Years to 75 Years
SexALL
Healthy VolunteersNo
Study Sites25

Inclusion Criteria: * Pre-existing diagnosis of primary immunodeficiency with features of hypogammaglobulinemia requiring IgG replacement therapy * No serious bacterial infection within the last 3 months prior to or during Screening * Currently on IgG replacement therapy (via IV or SC infusion) for...

Countries:United StatesCanada
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Frequently asked questions about IGIV-C 10%

What is IGIV-C used for?

IGIV-C is an investigational intravenous immunoglobulin product being studied for use in myasthenia gravis, including generalized myasthenia gravis and myasthenia gravis exacerbations, as well as primary immunodeficiency. It is being developed by Grifols, S.A. (GRFS) and is currently in clinical trials.

Who makes IGIV-C?

IGIV-C is being developed by Grifols, S.A., a biopharmaceutical company traded on the NASDAQ under the ticker GRFS. The company is conducting clinical trials to evaluate the efficacy and safety of IGIV-C in patients with myasthenia gravis and primary immunodeficiency.

What phase is IGIV-C in?

IGIV-C is in Phase 2 clinical development for generalized myasthenia gravis and myasthenia gravis. It has also been studied in Phase 3 trials for myasthenia gravis exacerbations and primary immunodeficiency. All trials listed for IGIV-C have been completed.

What clinical trials has IGIV-C been in?

IGIV-C has been studied in several completed clinical trials, including NCT02413580 for myasthenia gravis exacerbations, NCT02473952 for generalized myasthenia gravis, NCT02473965 for corticosteroid dependent myasthenia gravis, and NCT02604810 for primary immunodeficiency. These trials were randomized, double-blind, and placebo-controlled.

Is IGIV-C the same as IGSC 20%?

IGIV-C is not the same as IGSC 20%. IGIV-C is an intravenous immunoglobulin product, while IGSC 20% is a subcutaneous immunoglobulin product. Both are being studied by Grifols for different conditions, with IGIV-C evaluated in myasthenia gravis and IGSC 20% evaluated in primary immunodeficiency.