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

Double-blind, Randomized, Placebo-controlled, Prospective Phase III Study Evaluating Efficacy and Safety of Panzyga in Primary Infection Prophylaxis in Patients With Chronic Lymphocytic Leukemia ("PRO-SID" Study)

Phase 3

Active, not recruiting

Conditions: Hypogammaglobulinemia
Chronic Lymphocytic Leukemia

Interventions: Biological: Panzyga
Other: Placebo

First Posted Date: 2020-08-06

Last Posted Date: 2024-10-23

Lead Sponsor: Octapharma

Target Recruit Count: 247

Registration Number: NCT04502030

Locations: 🇹🇷
Octapharma Research Site, Melikgazi/Kayseri, Turkey

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

Phase 2

Withdrawn

Conditions: Immune-Mediated Necrotizing Myopathy

Interventions: Drug: Gamunex-C
Drug: Albumin

First Posted Date: 2020-06-29

Last Posted Date: 2022-10-24

Lead Sponsor: University of Washington

Registration Number: NCT04450654

Locations: 🇺🇸
University of Washington, Seattle, Washington, United States

Study of SOC Plus IVIG Compared to SOC Alone in the Treatment of COVID-19

Phase 4

Completed

Conditions: Sars-CoV2

Interventions: Drug: Octagam

First Posted Date: 2020-06-02

Last Posted Date: 2021-06-25

Lead Sponsor: George Sakoulas, MD

Target Recruit Count: 34

Registration Number: NCT04411667

Locations: 🇺🇸
Sharp Grossmont Hospital, La Mesa, California, United States
🇺🇸
Sharp Memorial Hospital, San Diego, California, United States

Convalescent Plasma vs Human Immunoglobulin to Treat COVID-19 Pneumonia

Phase 3

Completed

Conditions: COVID-19 Pneumonia

Interventions: Drug: Plasma from COVID-19 convalescent patient
Drug: Human immunoglobulin

First Posted Date: 2020-05-11

Last Posted Date: 2020-11-30

Lead Sponsor: Centenario Hospital Miguel Hidalgo

Target Recruit Count: 196

Registration Number: NCT04381858

Locations: 🇲🇽
Centenario Hospital Miguel Hidalgo, Aguascalientes, Mexico

Polyvalent Immunoglobulin in COVID-19 Related ARds

Phase 3

Completed

Conditions: COVID-19
Acute Respiratory Distress Syndrome

Interventions: Drug: Placebo
Drug: Human immunoglobulin

First Posted Date: 2020-04-17

Last Posted Date: 2021-08-19

Lead Sponsor: Centre Hospitalier St Anne

Target Recruit Count: 146

Registration Number: NCT04350580

Locations: 🇫🇷
CH Aulnay, Aulnay-sous-Bois, France
🇫🇷
Hopital de Vannes, Vannes, France
🇫🇷
Hopital d'instruction des armées Percy, Clamart, France

and more 39 locations

rATG Versus rATG Combined With Intravenous Immunoglobulin (IVIG) Induction Immunosuppression in HLA Incompatible Transplantation (INHIBIT)

Phase 3

Completed

Conditions: Kidney Transplantation

Interventions: Drug: Privigen
Drug: Thymoglobulin
Other: Plasma Exchange

First Posted Date: 2020-03-10

Last Posted Date: 2024-08-15

Lead Sponsor: Institute for Clinical and Experimental Medicine

Target Recruit Count: 17

Registration Number: NCT04302805

Locations: 🇨🇿
Institute for Clinical and Experimental Medicine, Prague, Czechia

Safety and Efficacy of IGIV 10% in Patients With Autoimmune Encephalitis:

Phase 2

Completed

Conditions: Autoimmune Encephalitis

Interventions: Drug: Immunoglobulin G

First Posted Date: 2019-11-25

Last Posted Date: 2020-06-30

Lead Sponsor: Green Cross Corporation

Target Recruit Count: 23

Registration Number: NCT04175522

Locations: 🇰🇷
Seoul National University Hospital, Seoul, Korea, Republic of

IVIG in the Treatment of Autoimmune Small Fiber Neuropathy with TS-HDS, FGFR-3, or Plexin D1 Antibodies

Phase 2

Active, not recruiting

Conditions: Immune-Mediated Neuropathy
Autoimmune Small Fiber Neuropathy
Small Fiber Neuropathy
Inflammatory Polyneuropathy

Interventions: Drug: Panzyga IVIG
Drug: Placebo

First Posted Date: 2019-11-06

Last Posted Date: 2025-03-24

Lead Sponsor: Henry Ford Health System

Target Recruit Count: 20

Registration Number: NCT04153422

Locations: 🇺🇸
Henry Ford Health, Detroit, Michigan, United States

A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of IgPro20 in Adults With Dermatomyositis (DM)

Phase 3

Terminated

Conditions: Dermatomyositis

Interventions: Drug: Placebo
Drug: human immunoglobulin G

First Posted Date: 2019-08-05

Last Posted Date: 2025-02-24

Lead Sponsor: CSL Behring

Target Recruit Count: 126

Registration Number: NCT04044690

Locations: 🇺🇸
8401210 - University of Pennsylvania, Philadelphia, Pennsylvania, United States
🇯🇵
3920125 - Tokyo Medical And Dental University Medical Hospital, Bunkyo, Tokyo, Japan
🇲🇽
4840081 - Centro Integral en Reumatologia, SA de CV, Guadalajara, Jalisco, Mexico

and more 73 locations

Study of Combined Therapy IVIG-SN 10% and Acetylsalicylic Acid in Kawasaki Disease

Phase 4

Completed

Conditions: Kawasaki Disease

Interventions: Drug: Immunoglobulin G
Drug: Acetylsalicylic acid

First Posted Date: 2019-07-01

Last Posted Date: 2020-05-21

Lead Sponsor: Green Cross Corporation

Target Recruit Count: 45

Registration Number: NCT04003844

Locations: 🇰🇷
Hallym University Sacred Heart Hospital, Anyang, Korea, Republic of
🇰🇷
Kyung Hee University Medical Center, Seoul, Korea, Republic of
🇰🇷
The Catholic University of Korea Seoul St. Mary's Hospital, Seoul, Korea, Republic of

and more 4 locations

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