Gamunex-C

BIOLOGICAL6 trials

Conditions

Anterior Segment InflammationCIDP (Chronic Inflammatory Demyelinating Polyradiculoneuropathy)COVID-19Corneal Graft FailureCorneal NeovascularizationImmune-Mediated Necrotizing MyopathyPrimary Immunodeficiency

Phase 1

Subconjunctival IVIg (Gamunex-C) Injection for Corneal Neovascularization and Inflammatory Conditions

WithdrawnNCT02042027

University of UtahAnterior Segment Inflammation, Corneal Graft Failure, Corneal Neovascularization

Start: 2014-07-31End: 2016-07-31Updated: 2016-08-05

Phase 2

Monotherapy IVIG Gamunex-C for HMG-CoA Reductase Auto-Antibody Positive Necrotizing Myopathy Treatment (The MIGHT Trial)

WithdrawnNCT04450654

University of WashingtonImmune-Mediated Necrotizing Myopathy

Start: 2022-05-31End: 2022-07-25Updated: 2022-10-24

Study to Evaluate the Safety and Efficacy of High Dose Intravenous Immune Globulin (IVIG) Plus Standard Medical Treatment (SMT) Versus SMT Alone in Participants in Intensive Care Unit (ICU) With Coronavirus Disease (COVID-19)

CompletedNCT04480424

Grifols Therapeutics LLCCOVID-19

Start: 2020-09-17End: 2021-10-25Updated: 2022-10-07

Phase 3

A Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of Immune Globulin (Human) 10% (Gamunex-C) PEG Process (IVIG-PEG) Compared to Gamunex-C in Participants With Primary Humoral Immunodeficiency

CompletedNCT04561115

Grifols Therapeutics LLCPrimary Immunodeficiency

Start: 2020-09-02End: 2022-03-28Updated: 2023-06-05

A Study to Evaluate the Pharmacokinetics and Safety of XEMBIFY Versus Gamunex-C in Participants With Chronic Inflammatory Demyelinating Polyradiculoneuropathy

RecruitingNCT07540221

Grifols Therapeutics LLCCIDP (Chronic Inflammatory Demyelinating Polyradiculoneuropathy)

Start: 2026-04-02End: 2027-12-31Target: 40Updated: 2026-09-04

Phase 4

Pharmacokinetics, Safety, and Tolerability of Subcutaneous GAMUNEX-C in Pediatric Subjects With Primary Immunodeficiency

CompletedNCT01465958

Grifols Therapeutics LLCPrimary Immunodeficiency

Start: 2011-11-30End: 2013-10-31Updated: 2015-03-13

Related Papers

Pharmacokinetics, Safety, and Tolerability of Subcutaneous Immune Globulin Injection (Human), 10 % Caprylate/Chromatography Purified (GAMUNEX®-C) in Pediatric Patients with Primary Immunodeficiency Disease.

2016-06-255 citations