Gamunex-C: Clinical Trials

3 completed, 2 withdrawn, 1 recruiting, 1 terminated. 3 Phase 3, 2 Phase 2, 1 Phase 1, 1 Phase 4.

By phase and status

Phase	Trials	Status
Phase 3	3	Completed 1, Recruiting 1, Terminated 1
Phase 2	2	Completed 1, Withdrawn 1
Phase 1	1	Withdrawn 1
Phase 4	1	Completed 1

Follow Gamunex-C: new trials by email Literature Review of Gamunex-C trials Research Report on Gamunex-C

Trials newest first · largest first

Tick up to 5 trials to compare them side by side (eligibility, arms, endpoints, adverse events) in a Literature Matrix.

Trial	Phase	Status	Sponsor	Enrollment	Start	Updated
A Study to Evaluate the Pharmacokinetics and Safety of XEMBIFY Versus Gamunex-C in Participants With Chronic Inflammatory Demyelinating Polyradiculoneuropathy Gamunex-C, Xembify - CIDP (Chronic Inflammatory Demyelinating Polyradiculoneuropathy)	Phase 3	Recruiting	Grifols Therapeutics LLC	40	2026-04-02	2026-10-09
Monotherapy IVIG Gamunex-C for HMG-CoA Reductase Auto-Antibody Positive Necrotizing Myopathy Treatment (The MIGHT Trial) Gamunex-C, Albumin - Immune-Mediated Necrotizing Myopathy	Phase 2	Withdrawn	University of Washington		2022-05-01	2022-10-24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) GAMUNEX-C, Standard Medical Treatment - COVID-19	Phase 2	Completed	Grifols Therapeutics LLC	100	2020-09-17	2022-10-07
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 Gamunex-C, IVIG-PEG - Primary Immunodeficiency	Phase 3	Completed	Grifols Therapeutics LLC	33	2020-09-02	2023-06-05
IVIG in Patients With VGKC Ab Associated Autoimmune Epilepsy Intravenous Immunoglobulin, Placebos, Normal Saline - Autoimmune Epilepsy	Phase 3	Terminated	Mayo Clinic	17	2016-02-01	2019-12-30
Subconjunctival IVIg (Gamunex-C) Injection for Corneal Neovascularization and Inflammatory Conditions Gamunex-C - Corneal Neovascularization, Corneal Graft Failure	Phase 1	Withdrawn	University of Utah		2014-07-01	2016-08-05
Pharmacokinetics, Safety, and Tolerability of Subcutaneous GAMUNEX-C in Pediatric Subjects With Primary Immunodeficiency GAMUNEX-C - Primary Immunodeficiency	Phase 4	Completed	Grifols Therapeutics LLC	12	2011-11-01	2015-03-13

Conditions studied

Primary Immunodeficiency Diseases (2)  ·  COVID-19 (1)  ·  Corneal Neovascularization (1)  ·  Coronaviridae Infections (1)  ·  Coronavirus Infections (1)  ·  Polyradiculoneuropathy, Chronic Inflammatory Demyelinating (1)  ·  Virus Diseases (1)

Sponsors

Grifols Therapeutics LLC (4)  ·  Mayo Clinic (1)  ·  University of Utah (1)  ·  University of Washington (1)

Countries

United States (7)  ·  Czechia (1)  ·  Poland (1)  ·  Romania (1)

Top investigators

Balamurali K Ambati, M.D., Ph.D., M.B.A. (1)  ·  James S Andrews, MD (1)  ·  Sean Pittock, M.D. (1)  ·  Simon Mahler, MD (1)

Results publications

PMID 27342758