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

Therapies for Down Syndrome Regression Disorder

Phase 2

Recruiting

Conditions: Down Syndrome
Regression

Interventions: Drug: Lorazepam
Drug: Intravenous immunoglobulin (IVIG)
Drug: Tofacitinib

First Posted Date: 2022-12-22

Last Posted Date: 2025-03-27

Lead Sponsor: University of Colorado, Denver

Target Recruit Count: 66

Registration Number: NCT05662228

Locations: 🇺🇸
Children's Hospital Los Angeles, Los Angeles, California, United States
🇺🇸
Children's Hospital Colorado, Aurora, Colorado, United States

A Study to Evaluate Efficacy, Safety, and PK of XEMBIFY®+Standard Medical Treatment (SMT) Compared to Placebo+SMT to Prevent Infections in Participants With HGG and Recurrent or Severe Infections Associated With B-cell Chronic Lymphocytic Leukemia, Multiple Myeloma, and Non-Hodgkin Lymphoma

Phase 3

Recruiting

Conditions: Hypogammaglobulinemia
Bacterial Infections
B-cell Chronic Lymphocytic Leukemia
Multiple Myleoma
Non-Hodgkin Lymphoma

Interventions: Drug: Xembify
Drug: Placebo

First Posted Date: 2022-12-09

Last Posted Date: 2025-05-02

Lead Sponsor: Grifols Therapeutics LLC

Target Recruit Count: 386

Registration Number: NCT05645107

Locations: 🇧🇦
GC2202 Study Site 701, Sarajevo, Bosnia and Herzegovina
🇺🇸
GC2202 Decentralized Study Site 114, Morrisville, North Carolina, United States
🇧🇬
GC2202 Study Site 211, Sofia, Bulgaria

and more 52 locations

A Study of ELAPRASE in Treatment-naïve Participants With Hunter Syndrome (Mucopolysaccharidosis [MPS] II)

Phase 4

Recruiting

Conditions: Mucopolysaccharidosis (MPS)
Hunter Syndrome

Interventions: Drug: ELAPRASE
Drug: Rituximab
Drug: Methotrexate
Drug: Intravenous Immunoglobulin (IVIG)

First Posted Date: 2022-08-10

Last Posted Date: 2025-03-04

Lead Sponsor: Takeda

Target Recruit Count: 5

Registration Number: NCT05494593

Locations: 🇺🇸
Phoenix Childrens Hospital, Phoenix, Arizona, United States
🇺🇸
Children's Hospital and Research Center at Oakland, Oakland, California, United States
🇺🇸
Rady Childrens Hospital San Diego - PIN, San Diego, California, United States

and more 5 locations

Usage of Spirometry in Managing IgG Therapy in CVID with Airway Disease

Phase 4

Recruiting

Conditions: Common Variable Immunodeficiency

Interventions: Drug: Hizentra

First Posted Date: 2022-01-18

Last Posted Date: 2025-03-11

Lead Sponsor: University of Alabama at Birmingham

Target Recruit Count: 22

Registration Number: NCT05193552

Locations: 🇺🇸
Community Health 20, Birmingham, Alabama, United States

BIVV020 (SAR445088) n Prevention and Treatment of Antibody-mediated Rejection (AMR)

Phase 2

Active, not recruiting

Conditions: Transplant Rejection

Interventions: Drug: BIVV020 (SAR445088)
Drug: Antithymocyte globulin (ATG)
Drug: Intravenous immunoglobulin (IVIg)
Drug: Rituximab or biosimilar
Drug: Corticosteroids
Drug: Tacrolimus
Drug: Mycophenolate

First Posted Date: 2021-12-14

Last Posted Date: 2025-01-10

Lead Sponsor: Sanofi

Target Recruit Count: 48

Registration Number: NCT05156710

Locations: 🇺🇸
Massachusetts General Hospital- Site Number : 8400007, Boston, Massachusetts, United States
🇺🇸
Cedars-Sinai Medical Center- Site Number : 8400100, Los Angeles, California, United States
🇺🇸
University of California Los Angeles Medical Center- Site Number : 8400103, Los Angeles, California, United States

and more 24 locations