Human immunoglobulin G

Generic Name: Human immunoglobulin G

Brand Names: Asceniv, Bivigam, Cuvitru, Flebogamma, Gamastan, Gammagard, Gammaked, Gammaplex, Gamunex, Hizentra, Hyqvia 5 G / 50 Ml Kit, Igivnex, Kiovig, Octagam, Panzyga, Privigen, Xembify, HyQvia, Flebogamma DIF (previously Flebogammadif)

Drug Type: Biotech

CAS Number: 308067-58-5

Unique Ingredient Identifier: 66Y330CJHS

Background: Intravenous immunoglobulin (IVIg) is a mixture of IgG1 and other antibodies derived from healthy human plasma via Cohn fractionation. The purification process includes cold alcohol fractionation, polyethylene glycol precipitation, and ion exchange chromatography. IVIg contains the same distribution of IgG antibody subclasses as is found in the general human population. IgG subclasses are fully represented in the following proportions: 70.3% IgG1, 24.7% IgG2, 3.1% IgG3, and 1.9% IgG4. IVIg is used in the treatment of immunodeficiencies, as well as autoimmune and inflammatory disorders.

Indication: Human immunoglobulin G is indicated for the following conditions:

Associated Conditions: Acute Idiopathic Thrombocytopenic Purpura, Bacterial Infections, Chronic Idiopathic Thrombocytopenic Purpura, Chronic Inflammatory Demyelinating Polyradiculoneuropathy, Coronary Artery Aneurysm, Dermatomyositis (DM), Hepatitis A, Measles, Multifocal Motor Neuropathy (MMN), Primary humoral immunodeficiency, Rubella, Secondary humoral immunodeficiency, Varicella

Associated Therapies: Maintenance therapy

Clinical Trials

Study of IgPro20 to Prevent Infection in People With Multiple Myeloma and Hypogammaglobulinemia

Phase 2

Recruiting

Conditions: Multiple Myeloma
Hypogammaglobulinemia
Hypogammaglobulinemia, Acquired

Interventions: Drug: IgPro20

First Posted Date: 2025-05-16

Last Posted Date: 2025-05-16

Lead Sponsor: Memorial Sloan Kettering Cancer Center

Target Recruit Count: 100

Registration Number: NCT06976476

Locations: 🇺🇸
Memorial Sloan Kettering Basking Ridge (All Protocol Activities), Basking Ridge, New Jersey, United States
🇺🇸
Memorial Sloan Kettering Monmouth (All Protocol Activities), Middletown, New Jersey, United States
🇺🇸
Memorial Sloan Kettering Bergen (All Protocol Activities), Montvale, New Jersey, United States

and more 5 locations

V-IMMUNE: A Novel Immunoglobulin Therapy for Immunodeficiency

Phase 3

Not yet recruiting

Conditions: Immunodeficiencies
Primary Immunodeficiencies (PID)
Agammaglobulinemia

Interventions: Biological: Intravenous immunoglobulin (IVIG)

First Posted Date: 2025-05-01

Last Posted Date: 2025-05-08

Lead Sponsor: On Pharma Importadora, Exportadora e Distribuidora de Medicamentos LTDA.

Target Recruit Count: 50

Registration Number: NCT06954441

A Study of TAK-881 and HyQvia in Healthy Adults

Phase 1

Recruiting

Conditions: Healthy Volunteers

Interventions: Biological: TAK-881
Biological: HyQvia
Device: SC Investigational Needle Sets

First Posted Date: 2025-03-26

Last Posted Date: 2025-05-07

Lead Sponsor: Takeda

Target Recruit Count: 30

Registration Number: NCT06895967

Locations: 🇺🇸
Celerion, Tempe, Arizona, United States

Targeting Collagen VII Antibodies with IV IgG in Dystrophic Epidermolysis Bullosa

Phase 1

Not yet recruiting

Conditions: Epidermolysis Bullosa
Epidermolysis Bullosa Acquisita
Dystrophic Epidermolysis Bullosa
Recessive Dystrophic Epidermolysis Bullosa

Interventions: Biological: Immunoglobulin G

First Posted Date: 2025-02-19

Last Posted Date: 2025-02-19

Lead Sponsor: M. Peter Marinkovich

Target Recruit Count: 8

Registration Number: NCT06834035

Locations: 🇺🇸
Stanford University, Redwood City, California, United States

Phase 1 Study of ART5803 Safety and PK After IVIG in Healthy Participants

Phase 1

Recruiting

Conditions: Autoimmune Encephalitis Caused by N-Methyl D-Aspartate Receptor Antibody
Autoimmune Encephalitis Caused by N-Methyl D-Aspartate Receptor Antibody (Disorder)
Autoimmune Encephalitis

Interventions: Drug: ART5803
Drug: Intravenous immunoglobulin (IVIG)

First Posted Date: 2024-12-31

Last Posted Date: 2025-04-11

Lead Sponsor: Arialys Therapeutics

Target Recruit Count: 6

Registration Number: NCT06753955

Locations: 🇦🇺
Nucleus Network Pty Ltd, Melbourne, Victoria, Australia

A Study to Compare TAK-881 and HYQVIA in Adults With Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP)

Phase 3

Not yet recruiting

Conditions: Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP)

Interventions: Biological: TAK-881
Biological: HYQVIA
Device: SC Investigational Needle Sets

First Posted Date: 2024-12-24

Last Posted Date: 2024-12-24

Lead Sponsor: Takeda

Target Recruit Count: 59

Registration Number: NCT06747351

Double-blind, Randomized, Placebo-controlled Study Evaluating Efficacy and Safety of IgPro20 in Post-COVID-19 POTS

Phase 3

Recruiting

Conditions: Post-COVID Postural Orthostatic Tachycardia Syndrome

Interventions: Biological: Placebo
Biological: IgPro20

First Posted Date: 2024-07-29

Last Posted Date: 2025-04-16

Lead Sponsor: CSL Behring

Target Recruit Count: 177

Registration Number: NCT06524739

Locations: 🇺🇸
Sunbeam Clinical Research, McKinney, Texas, United States
🇺🇸
Hope Research Network, Miami, Florida, United States
🇺🇸
Well Pharma Medical Research, Corp, Miami, Florida, United States

and more 35 locations

Add-on Intravenous Immunoglobulins in Early Myositis

Phase 2

Recruiting

Conditions: Dermatomyositis
Antisynthetase Syndrome
Immune-Mediated Necrotizing Myopathy
Polymyositis
Myositis
Inflammatory Myopathy, Idiopathic

Interventions: Drug: Immune Globulin Intravenous (Human)
Drug: Placebo

First Posted Date: 2023-04-27

Last Posted Date: 2023-04-27

Lead Sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Target Recruit Count: 48

Registration Number: NCT05832034

Locations: 🇳🇱
Department of Neurology, Amsterdam UMC, location AMC, Amsterdam, North- Holland, Netherlands

A Study About How TAK-881 is Processed by the Body and Side Effects in People With Primary Immunodeficiency Diseases

Phase 2

Active, not recruiting

Conditions: Primary Immunodeficiency Diseases (PID)

Interventions: Biological: TAK-881
Biological: HYQVIA

First Posted Date: 2023-03-06

Last Posted Date: 2025-05-02

Lead Sponsor: Takeda

Target Recruit Count: 65

Registration Number: NCT05755035

Locations: 🇺🇸
University of California Irvine Medical Center, Irvine, California, United States
🇺🇸
Allergy and Asthma Clinical Research, Walnut Creek, California, United States
🇺🇸
National Jewish Medical And Research Center, Denver, Colorado, United States

and more 38 locations

Evaluating Efgartigimod in Patients with Guillain-Barré Syndrome

Phase 2

Recruiting

Conditions: Guillain-Barre Syndrome

Interventions: Drug: Efgartigimod Alfa-Fcab
Drug: Intravenous Immunoglobulin (IVIg)

First Posted Date: 2023-01-27

Last Posted Date: 2025-03-30

Lead Sponsor: Chafic Karam

Target Recruit Count: 30

Registration Number: NCT05701189

Locations: 🇺🇸
Hospital of University of Pennsylvania, Philadelphia, Pennsylvania, United States

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