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
Subcutaneous Immunoglobulin Treatment for Multifocal Motor Neuropathy
- Conditions
- Multifocal Motor Neuropathy
- Interventions
- First Posted Date
- 2005-12-22
- Last Posted Date
- 2008-02-21
- Lead Sponsor
- University of Aarhus
- Target Recruit Count
- 10
- Registration Number
- NCT00268788
- Locations
- 🇩🇰
Aarhus University Hospital, Department of Neyrology, Aarhus, Denmark
Stem Cell Transplant for Immunologic or Histiocytic Disorders
- Conditions
- Hemophagocytic LymphohistiocytosisX-Linked Lymphoproliferative DisordersImmunologic Deficiency SyndromesChediak-Higashi SyndromeGriscelli SyndromeLangerhans-Cell Histiocytosis
- Interventions
- Procedure: Stem Cell TransplantDrug: Anti-thymocyte globulin (ATG)
- First Posted Date
- 2005-09-15
- Last Posted Date
- 2017-12-28
- Lead Sponsor
- Masonic Cancer Center, University of Minnesota
- Target Recruit Count
- 19
- Registration Number
- NCT00176865
- Locations
- 🇺🇸
Masonic Cancer Center University of Minnesota, Minneapolis, Minnesota, United States
Safety, Pharmacokinetic and Efficacy Study of a 10% Triple Virally Reduced Intravenous Immune Globulin Solution in Patients With Primary Immunodeficiency (Hypo- or Agammaglobulinemia)
- Conditions
- AgammaglobulinemiaPrimary Immunodeficiency Diseases (PID)Hypogammaglobulinemia
- First Posted Date
- 2005-09-13
- Last Posted Date
- 2021-08-24
- Lead Sponsor
- Baxalta now part of Shire
- Target Recruit Count
- 24
- Registration Number
- NCT00161993
- Locations
- 🇫🇮
Turku University Central Hospital, Turku, Finland
🇸🇪University Hospital MAS, Malmö, Sweden
🇸🇪Sundsvall Hospital, Sundsvall, Sweden
Efficacy and Safety of Xepol (Human Immunoglobulin) in Subjects With Post-Polio Syndrome (PPS)
- Conditions
- Post Polio Syndrome, PPS
- First Posted Date
- 2005-09-12
- Last Posted Date
- 2007-04-03
- Lead Sponsor
- Calliditas Therapeutics AB
- Target Recruit Count
- 124
- Registration Number
- NCT00160082
- Locations
- 🇸🇪
Huddinge University Hospital, Stockholm, Sweden
🇸🇪Uppsala Academic Hospital, Uppsala, Sweden
🇸🇪Sahlgrenska University Hospital, Gothenburg, Sweden
Intravenous Immunoglobulin (IVIg) for the Treatment of Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)
- Conditions
- Demyelinating DiseasesParaproteinemias
- First Posted Date
- 2002-12-10
- Last Posted Date
- 2008-03-04
- Target Recruit Count
- 60
- Registration Number
- NCT00001287
- Locations
- 🇺🇸
National Institute of Neurological Disorders and Stroke (NINDS), Bethesda, Maryland, United States
Drug Development Updates
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