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 Combined Therapy of Aspirin and "IVIG-SN" in Kawasaki Disease

Phase 4

Completed

Conditions: Kawasaki Disease

Interventions: Drug: immunoglobulin G

First Posted Date: 2012-02-02

Last Posted Date: 2012-09-20

Lead Sponsor: Green Cross Corporation

Target Recruit Count: 45

Registration Number: NCT01524939

Locations: 🇰🇷
Seoul ST. Mary's Hospital, Seoul, Korea, Republic of
🇰🇷
Kyung Hee university medical center, Seoul, Korea, Republic of
🇰🇷
Kyung Hee university at Gangdong, Seoul, Korea, Republic of

and more 4 locations

Evaluation of Efficacy and Tolerability of Hizentra®

Not Applicable

Conditions: Primary Immunodeficiency Disorders

Interventions: Drug: Hizentra

First Posted Date: 2011-05-17

Last Posted Date: 2012-07-17

Lead Sponsor: University of South Florida

Target Recruit Count: 50

Registration Number: NCT01354587

Locations: 🇺🇸
University of South Florida, St. Petersburg, Florida, United States

Efficacy and Safety of Immunoglobulin Intravenous (Human) 10% (NewGam) in Primary Immune Thrombocytopenia

Phase 3

Completed

Conditions: Primary Thrombocytopenia

Interventions: Drug: NewGam

First Posted Date: 2011-05-09

Last Posted Date: 2017-06-07

Lead Sponsor: Octapharma

Target Recruit Count: 40

Registration Number: NCT01349790

Locations: 🇩🇪
Abdulgabar Salama, Berlin, Germany

GCIV as an Adjuvant Therapy for Community-Acquired Severe Sepsis or Septic Shock

Phase 3

Terminated

Conditions: Severe Sepsis
Septic Shock

Interventions: Drug: Immunoglobulin G

First Posted Date: 2011-03-15

Last Posted Date: 2013-04-30

Lead Sponsor: Green Cross Corporation

Target Recruit Count: 214

Registration Number: NCT01315496

Locations: 🇰🇷
Kangdong Sacred Heart Hospital, Seoul, Korea, Republic of
🇰🇷
Gyrongsang National University Hospital, Jinju-si, Gyeongsangnam-do,, Korea, Republic of
🇰🇷
Kangnam Sacred Heart Hospital, Seoul, Korea, Republic of

and more 14 locations