DeepMed Research

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

Ig PRx in AECOPD: Pilot Study

Phase 2

Completed

Conditions: Chronic Obstructive Pulmonary Disease

Interventions: Drug: Intravenous immunoglobulin (IVIG)
Drug: Normal Saline

First Posted Date: 2016-02-24

Last Posted Date: 2019-11-27

Lead Sponsor: Ottawa Hospital Research Institute

Target Recruit Count: 48

Registration Number: NCT02690038

Locations: 🇨🇦
The Ottawa Hospital, General Campus, Ottawa, Ontario, Canada

Study to Evaluate Safety and Efficacy of Three Different Dosages of NewGam in Patients With Chronic Inflammatory Demyelinating Poly (Radiculo) Neuropathy

Phase 3

Completed

Conditions: Chronic Inflammatory Demyelinating Poly(Radiculo)Neuropathy

Interventions: Drug: NewGam

First Posted Date: 2015-12-23

Last Posted Date: 2021-02-16

Lead Sponsor: Octapharma

Target Recruit Count: 142

Registration Number: NCT02638207

Locations: 🇧🇬
St. Naum Hospital, Sofia, Bulgaria
🇷🇺
Neurology Research Centre, Moscow, Russian Federation
🇭🇺
Jahn Ferenc Del Pesti Korhaz, Budapest, Hungary

and more 23 locations

Efficacy and Safety of HyQvia (Immunoglobulin 10% With Recombinant Hyaluronidase) in Multifocal Motor Neuropathy (MMN)

Phase 2

Completed

Conditions: Multifocal Motor Neuropathy

Interventions: Drug: HyQvia
Drug: Subcuvia

First Posted Date: 2015-09-22

Last Posted Date: 2018-05-17

Lead Sponsor: Johannes Jakobsen

Target Recruit Count: 18

Registration Number: NCT02556437

Locations: 🇩🇰
Department of Neurology, Aarhus University Hospital, Aarhus C, Denmark
🇩🇰
Department of Neurology, Rigshospitalet, Copenhagen, Denmark

Effect of Privigen Against Graft Loss

Phase 3

Completed

Conditions: Kidney Transplantation

Interventions: Drug: Privigen (Human normal immunoglobulin G (IgG > 98 % purity))

First Posted Date: 2015-03-02

Last Posted Date: 2021-03-09

Lead Sponsor: Assistance Publique - Hôpitaux de Paris

Target Recruit Count: 18

Registration Number: NCT02374736

Locations: 🇫🇷
Service de Néphrologie et transplantation rénale - HU Saint-Louis, Paris, Ile De France, France

Efficacy and Safety Study of I10E in the Maintenance Treatment of Patients With CIDP: Extension of PRISM Study I10E-1302

Phase 3

Terminated

Conditions: Chronic Inflammatory Demyelinating Polyradiculoneuropathy

Interventions: Drug: I10E

First Posted Date: 2014-12-16

Last Posted Date: 2021-04-20

Lead Sponsor: Laboratoire français de Fractionnement et de Biotechnologies

Target Recruit Count: 19

Registration Number: NCT02317562

Locations: 🇹🇷
Ankara university medical school Neurology, Ankara, Turkey
🇮🇹
IRRCS Istutito Nazionale Neurologico Besta, Milano, Italy
🇫🇷
CHU de Bordeaux - Hôpital Pellegrin, Bordeaux, France

and more 27 locations

Efficacy and Safety Study of I10E in Treatment of Patients With CIDP

Phase 3

Completed

Conditions: Chronic Inflammatory Demyelinating Polyradiculoneuropathy

Interventions: Drug: I10E

First Posted Date: 2014-11-18

Last Posted Date: 2021-01-27

Lead Sponsor: Laboratoire français de Fractionnement et de Biotechnologies

Target Recruit Count: 44

Registration Number: NCT02293460

Locations: 🇫🇷
Hôpital Pontchaillou, Rennes, France
🇫🇷
Hôpital général du CHU de Dijon, Dijon, France
🇫🇷
CHU Paris - Hôpital Pitié salpétrière, Paris, France

and more 30 locations

An Open-Label Study to Evaluate the Efficacy of High-Dose Gammaplex in Children on the Autism Spectrum

Phase 4

Conditions: Asperger's Disorder
Autism
PDD
Autistic Disorder
Pervasive Developmental Disorder

Interventions: Drug: Gammaplex 5%

First Posted Date: 2014-07-25

Last Posted Date: 2015-04-16

Lead Sponsor: Isaac Melamed

Target Recruit Count: 30

Registration Number: NCT02199925

Locations: 🇺🇸
IMMUNOe International Research Centers, Centennial, Colorado, United States

Open Label Study of Subcutaneous Immunoglobulin (SCIg) in Myasthenia Gravis

Phase 2

Completed

Conditions: Myasthenia Gravis

Interventions: Drug: HIZENTRA ®

First Posted Date: 2014-04-01

Last Posted Date: 2021-06-02

Lead Sponsor: Mazen Dimachkie, MD

Target Recruit Count: 23

Registration Number: NCT02100969

Locations: 🇺🇸
University at Buffalo, Buffalo, New York, United States
🇺🇸
University of Texas Southwestern Medical Center, Dallas, Texas, United States
🇺🇸
Phoenix Neurological Associates, Phoenix, Arizona, United States

and more 2 locations

Subconjunctival IVIg (Gamunex-C) Injection for Corneal Neovascularization and Inflammatory Conditions

Phase 1

Withdrawn

Conditions: Corneal Neovascularization
Corneal Graft Failure
Anterior Segment Inflammation

Interventions: Drug: Gamunex-C

First Posted Date: 2014-01-22

Last Posted Date: 2016-08-05

Lead Sponsor: University of Utah

Registration Number: NCT02042027

Locations: 🇺🇸
John A. Moran Eye Center, Salt Lake City, Utah, United States

Safety Study of Intravenous Immunoglobulin (IVIG) Post-Portoenterostomy in Infants With Biliary Atresia

Phase 1

Completed

Conditions: Biliary Atresia

Interventions: Drug: Intravenous immunoglobulin (IVIG)

First Posted Date: 2013-05-16

Last Posted Date: 2019-10-01

Lead Sponsor: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Target Recruit Count: 30

Registration Number: NCT01854827

Locations: 🇺🇸
Children's Healthcare of Atlanta, Atlanta, Georgia, United States
🇺🇸
Children's Hospital Medical Center, Cincinnati, Ohio, United States
🇺🇸
Children's Hospital at Pittsburgh, Pittsburgh, Pennsylvania, United States

and more 4 locations

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