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 PHASE III STUDY TO MONITOR THE SAFETY, TOLERABILITY AND EFFICACY OF SUBCUTANEOUS HUMAN IMMUNOGLOBULIN (OCTANORM) IN PATIENTS WITH PRIMARY IMMUNODEFICIENCY DISEASES, INCLUDING (BUT NOT LIMITED TO) THOSE WHO HAVE COMPLETED THE SCGAM-01 TRIAL
- First Posted Date
- 2019-04-08
- Last Posted Date
- 2020-10-27
- Lead Sponsor
- Octapharma
- Target Recruit Count
- 27
- Registration Number
- NCT03907241
- Locations
- 🇨🇦
Octapharma Research Site, Edmonton, Alberta, Canada
Study to Evaluate the Efficacy and Safety of PANZYGA in Pediatric Patients With Chronic Immune Thrombocytopenia (ITP)
- First Posted Date
- 2019-03-07
- Last Posted Date
- 2024-08-07
- Lead Sponsor
- Octapharma
- Target Recruit Count
- 6
- Registration Number
- NCT03866798
- Locations
- 🇺🇸
Octapharma Research Site, Houston, Texas, United States
Immunoglobulin Replacement Therapy for Immunoglobulin G Subclass 2 Deficient Patients With Bronchiectasis
- Conditions
- Immunoglobulin Subclass DeficiencyBronchiectasis
- Interventions
- First Posted Date
- 2018-11-09
- Last Posted Date
- 2021-09-29
- Lead Sponsor
- University of Edinburgh
- Registration Number
- NCT03737617
- Locations
- 🇬🇧
Royal Infirmary of Edinburgh, Edinburgh, United Kingdom
Humoral Immunodeficiency in CLL and Therapy With Subcutaneous Ig
- First Posted Date
- 2018-11-05
- Last Posted Date
- 2020-08-26
- Lead Sponsor
- Rochester General Hospital
- Target Recruit Count
- 20
- Registration Number
- NCT03730129
- Locations
- 🇺🇸
Allergy, Immunology, Rheumatology at Rochester Regional Health, Rochester, New York, United States
Intravenous Immunoglobulins for the Treatment of Primary Sjögren's Syndrome Associated Painful Sensory Neuropathies
- Conditions
- Primary Sjögren's Syndrome Painful Sensory Neuropathies
- Interventions
- Drug: NaCl 0,9%
- First Posted Date
- 2018-10-09
- Last Posted Date
- 2024-08-29
- Lead Sponsor
- University Hospital, Strasbourg, France
- Target Recruit Count
- 24
- Registration Number
- NCT03700138
- Locations
- 🇫🇷
University Hospital, Strasbourg, france, Strasbourg, France
Two Dose Levels of Privigen in Pediatric CIDP
- Conditions
- Pediatric Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)
- Interventions
- First Posted Date
- 2018-09-25
- Last Posted Date
- 2025-05-07
- Lead Sponsor
- CSL Behring
- Target Recruit Count
- 30
- Registration Number
- NCT03684018
- Locations
- 🇺🇸
Phoenix Children's Hospital, Phoenix, Arizona, United States
🇺🇸Children's Hospital of Los Angeles, Los Angeles, California, United States
🇺🇸University of Iowa Hospitals and Clinics, Iowa City, Iowa, United States
Subcutaneous Ig in Allogeneic Stem Cell Transplant Recipients
- Conditions
- Hypogammaglobulinemia
- Interventions
- First Posted Date
- 2018-01-17
- Last Posted Date
- 2019-05-09
- Lead Sponsor
- University Health Network, Toronto
- Target Recruit Count
- 20
- Registration Number
- NCT03401268
- Locations
- 🇨🇦
Princess Margaret Hospital, Toronto, Ontario, Canada
Safety and Tolerability of Higher Infusion Parameters of IgPro20 (Hizentra) in Subjects With Primary Immunodeficiency (PID)
- First Posted Date
- 2017-01-27
- Last Posted Date
- 2020-03-25
- Lead Sponsor
- CSL Behring
- Target Recruit Count
- 49
- Registration Number
- NCT03033745
- Locations
- 🇺🇸
Icahn Medical Institute, New York, New York, United States
🇨🇦McGill University, Montréal, Quebec, Canada
🇨🇦The Ottawa Hospital, Ottawa, Ontario, Canada
Effectiveness of Intravenous Immunoglobulins (IVIG) in Toxic Shock Syndromes in Children
- Conditions
- Staphylococcal InfectionStreptococcal Infection
- Interventions
- First Posted Date
- 2016-09-14
- Last Posted Date
- 2021-05-03
- Lead Sponsor
- Hospices Civils de Lyon
- Registration Number
- NCT02899702
- Locations
- 🇫🇷
Hôpital Femme Mère Enfant, Bron, France
Study Evaluating Efficacy and Safety of Octagam 10% in Patients With Dermatomyositis (Idiopathic Inflammatory Myopathy)
- First Posted Date
- 2016-04-05
- Last Posted Date
- 2021-12-23
- Lead Sponsor
- Octapharma
- Target Recruit Count
- 95
- Registration Number
- NCT02728752
- Locations
- 🇷🇺
Orenburg State Medical University Based On Regional Clinical Hospital, Orenburg, Russian Federation
🇺🇸Arthritis & Osteoporosis Clinic, Waco, Texas, United States
🇭🇺Semmelweis University Dermatology Clinic, Budapest, Hungary
Drug Development Updates
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