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Vivaglobin (Immune Globulin Subcutaneous Human) - Summary



Vivaglobin®, Immune Globulin Subcutaneous (Human) is a pasteurized, polyvalent human normal immunoglobulin for subcutaneous infusion.

Vivaglobin®, Immune Globulin Subcutaneous (Human) is indicated for the treatment of patients with primary immune deficiency (PID).

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Published Studies Related to Vivaglobin (Immune Globulin Subcutaneous Human)

Treatment of diffuse systemic sclerosis with hyperimmune caprine serum (AIMSPRO): a phase II double-blind placebo-controlled trial. [2014]
biomarkers... CONCLUSIONS: These results confirm tolerability and safety of this novel

Increasing the time of exposure to aerosol measles vaccine elicits an immune response equivalent to that seen in 9-month-old Mexican children given the same dose subcutaneously. [2011.08.01]
BACKGROUND: A 30-second aerosol measles vaccination successfully primes children 12 months of age and older but is poorly immunogenic when given to 9-month-old children. We examined the immune responses when increasing the duration to aerosol exposure in 9-month-olds... CONCLUSIONS: Increasing exposure time to aerosol measles vaccine elicits immune responses that are comparable to those seen when an equivalent dose is administered by the subcutaneous route in 9-month-old infants.

Effects of ustekinumab administration on primate/human antigen-recall and humoral immune response functions. [2010.06]
BACKGROUND: Ustekinumab, a fully human immunoglobulin (Ig) G1K monoclonal antibody directed against the p40 subunit of interleukin (IL)-12/23, has demonstrated efficacy in patients with moderate-to-severe psoriasis. OBJECTIVE: To evaluate the effect of IL-12/23 inhibition on immunocompetency by antigen-recall response in a preclinical multiple-dose toxicology study and three single-dose, phase 1 studies... CONCLUSION: Results in nonhuman primates and human patients suggest that ustekinumab treatment does not significantly impair recall humoral immune system functions.

GAD65 vaccination: 5 years of follow-up in a randomised dose-escalating study in adult-onset autoimmune diabetes. [2009.07]
AIMS/HYPOTHESIS: The aim of this study was to ascertain whether treatment of GAD65 autoantibody (GADA)-positive diabetic patients with alum-formulated recombinant GAD65 (GAD-alum) is safe and does not compromise beta cell function... INTERPRETATION: The primary outcome of safety was achieved, since no severe study-related adverse events occurred. TRIAL REGISTRATION: Because the study was initiated before 1 July 2005, the protocol was not registered in a registry.

Effect of therapeutic integrin (CD11a) blockade with efalizumab on immune responses to model antigens in humans: results of a randomized, single blind study. [2008.11]
Efalizumab is a humanized monoclonal CD11a antibody approved for treatment of psoriasis. Its immunomodulatory effects led us study how immune responses are modified and the possible consequences for vaccinations in clinical practice... These results expand our knowledge of how immune responses are modulated in humans by CD11a blockade and have implications for vaccinations of patients treated with this agent.

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Clinical Trials Related to Vivaglobin (Immune Globulin Subcutaneous Human)

Pharmacokinetics, Safety, and Tolerability of Subcutaneous GAMUNEX-C in Pediatric Subjects With Primary Immunodeficiency [Recruiting]
The purpose of this open-label study is to evaluate the pharmacokinetics, safety, and tolerability of subcutaneously (SC; under the skin) administered GAMUNEX®-C compared to intravenously (IV; through the vein) administered GAMUNEX®-C in subjects 2-16 years of age with Primary Immunodeficiency.

Study of Subcutaneous Immune Globulin in Patients Requiring IgG Replacement Therapy (Japan Study) [Not yet recruiting]
The objective of this study is to assess the efficacy, safety, tolerability, and pharmacokinetics of a subcutaneous immune globulin (IgPro20) in subjects with primary immunodeficiency (PID). In addition, the study will assess the health-related quality of life and pharmacoeconomic aspects related to treatment with IgPro20.

Tolerability and Safety of Immune Globulin Subcutaneous Solution and rHuPH20 in Primary Immunodeficiency Diseases (PID) [Recruiting]
The purpose of the study is to assess the long-term safety, tolerability, and practicability of the subcutaneous treatment with Immune Globulin Subcutaneous (IGSC) facilitated with recombinant human hyaluronidase (rHuPH20) in subjects with Primary Immunodeficiency Diseases (PID) who have completed Baxter Clinical Study Protocol No. 160603

Multicenter Study of Long-Term Clinical Outcomes of Subcutaneous Immune Globulin IgPro20 in Subjects With Primary Immunodeficiency (Japan Study) [Not yet recruiting]
The purpose of this study is to assess the long-term efficacy, tolerability, and safety of IgPro20 in subjects with primary immunodeficiency (PID) as an extension to the preceding follow-up study ZLB07_001CR (NCT01458171).

Evaluation of Efficacy and Tolerability of Hizentra� [Recruiting]

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Reports of Suspected Vivaglobin (Immune Globulin Subcutaneous Human) Side Effects

Headache (7)OFF Label USE (4)Infusion Site Swelling (4)Transmission of AN Infectious Agent VIA A Medicinal Product (4)Fatigue (3)Thrombocytopenia (3)Back Pain (3)Dyspnoea (3)Herpes Simplex Serology Positive (3)Vertigo (3)more >>

Page last updated: 2014-11-30

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