Clinical trials: Intravenous Immunoglobulin
Primary Immunodeficiency Disease
IVIG Boya: Safety, Efficacy, and Pharmacokinetics
The goal of this phase 3, open-label, single-group clinical trial is to assess the efficacy of Boya IVIG in maintaining the mean number of serious bacterial infections to less than one per year in participants with primary…
- Trial name
- BoyaIVIG (NCT06150833)
- Testing
- Boya IVIG
- Volunteers
- 50 people
- Sponsor
- Azidus Brasil
RSV Illness in ≤12 Months of Participants
A Study to Evaluate a Single Intravenous Dose of Motavizumab for the Treatment of Children Hospitalized With Respiratory Syncytial Virus (RSV) Illness
The primary objective of this study is to describe the effect of a single dose of medication compared to placebo in the upper respiratory tract in previously healthy children less than or equal to 12 months of age who are…
- Trial name
- NCT00421304
- Testing
- Motavizumab
- Where
- 35 sites in United States, Australia and 3 more
- Volunteers
- 118 people
- Sponsor
- MedImmune LLC
Agammaglobulinemia, IgG Deficiency
Efficacy and Safety of Intravenous Immunoglobulin IVIG-F10 in Patients With Primary Immunodeficiencies (PID)
The purpose of this study is to demonstrate the effect of IVIG-F10 on the prevention of serious bacterial infections in patients with primary immunodeficiency.
- Conditions
- Agammaglobulinemia, IgG Deficiency, Common Variable Immunodeficiency
- Trial name
- NCT00168012
- Testing
- Immunoglobulins Intravenous (Human)
- Volunteers
- 42 people
- Sponsor
- CSL Behring
Hepatitis B Virus Associated Liver Disease
Pilot Study to Assess the Pharmacokinetics of Intravenous Nabi 5% Hepatitis B Immune Globulin (Boca HBVIg) Used in Combination With Lamivudine for Patients With Hepatitis B Virus (HBV) Associated Liver Disease Undergoing Liver Transplantation
The purpose of this study is to find the best monthly dose schedule for the new Hepatitis Immune Globulin (Boca HBVIg, a study drug) when used in combination with an antiviral agent Lamivudine after liver transplantation.
- Trial name
- NCT01421212
- Testing
- Hepatitis B Immune Globulin (Boca HBVIg)
- Where
- 11 sites in United States
- Volunteers
- 30 people
- Sponsor
- Biotest Pharmaceuticals Corporation
Primary Immune Deficiency Disorder
Follow-up Study of Subcutaneous Immune Globulin in Patients Requiring IgG Replacement Therapy (Japan Study)
The objective of this study is to assess the long-term safety, tolerability, and efficacy of IgPro20 in subjects with primary immunodeficiency (PID) as a follow-up to the pivotal study ZLB06_002CR (NCT01199705).
- Trial name
- NCT01458171
- Testing
- Immune globulin subcutaneous (Human)
- Where
- 9 sites in Japan
- Volunteers
- 23 people
- Sponsor
- CSL Behring
Primary Immune Deficiency
Multicenter Study of Long-Term Clinical Outcomes of Subcutaneous Immune Globulin IgPro20 in Subjects With Primary Immunodeficiency (Japan Study)
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).
- Trial name
- NCT01461018
- Testing
- Immune globulin subcutaneous (Human)
- Where
- 9 sites in Japan
- Volunteers
- 22 people
- Sponsor
- CSL Behring
Atrophy, Geographic
Pharmacokinetic (PK) Study of GSK933776 in Healthy Volunteers
This study is intended to enable a possible transition to intramuscular (IM) or subcutaneous (SQ) administration for subsequent studies with GSK933776 by characterizing the safety, tolerability, PK and pharmacodynamic profiles…
- Trial name
- NCT02033668
- Testing
- GSK933776 for SQ administration, GSK933776 for IM administration, GSK933776 for IV administration
- Where
- United States
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Immune Thrombocytopenic Purpura (ITP)
Efficacy and Safety Study of a 10% Triple Virally Reduced Intravenous Immune Globulin Solution in Adult Subjects With Chronic Idiopathic Thrombocytopenic Purpura
The purpose of this study is to evaluate whether Immune Globulin Intravenous (Human), 10% TVR (Triple Virally Reduced) Solution is an effective and safe treatment in patients with chronic idiopathic thrombocytopenic purpura.
- Trial name
- NCT00162006
- Testing
- Immune Globulin Intravenous (Human), 10% Triple Virally Reduced Solution
- Where
- 11 sites in Czechia, Germany and 2 more
- Volunteers
- 28 people
- Sponsor
- Baxalta now part of Shire
Multifocal Motor Neuropathy
Phase III Clinical Trial of NPB-01maintenance Therapy in Patients With Multifocal Motor Neuropathy.
Patients diagnosed with Multifocal Motor Neuropathy were confirmed based on the European Federation of Neurological Societies/ Peripheral. Nerve Society Guideline.
- Trial name
- NCT01827072
- Testing
- NPB-01
- Where
- Japan
- Volunteers
- 13 people
- Sponsor
- Nihon Pharmaceutical Co., Ltd
Hepatitis C Infection, Viruses
Civacir® Polyclonal Immune Globulin (IgG) to Prevent Hepatitis C Virus (HCV) Recurrence in Liver Transplant Patients.
The purpose of this study is to test the safety and efficacy of Civacir® to prevent the recurrence of Hepatitis C Virus (HCV) after liver transplant.
- Conditions
- Hepatitis C Infection, Viruses, Hepatocellular Carcinoma, Hepatitis, Viral, Human
- Trial name
- NCT01804829
- Testing
- Civacir® 10%
- Where
- 23 sites in United States
- Volunteers
- 80 people
- Sponsor
- Biotest Pharmaceuticals Corporation
Kawasaki Disease
Study of Efficacy and Safety of Canakinumab in Pediatric Patients With Kawasaki Disease
The purpose of this trial is to evaluate whether, in Intravenous Immunoglobulin-naïve or refractory patients diagnosed with active Kawasaki disease, administration of canakinumab controls fever and acute phase reactants.
- Trial name
- NCT02980263
- Testing
- Canakinumab
- Sponsor
- Novartis Pharmaceuticals
Primary Immunodeficiency
Study of ProMetic BioTherapeutics Immune Globulin Intravenous (Human) 10%
Phase 3 multicenter, open-label study of safety, tolerability, efficacy, and pharmacokinetics (PK) of ProMetic's Immune Globulin Intravenous (Human) 10%, the investigational medicinal product [IMP]), in Adults and Children with…
- Trial name
- NCT02269163
- Testing
- Immune Globulin Intravenous, Prometic's Immune Globulin Intravenous 10%
- Where
- 13 sites in United States
- Volunteers
- 82 people
- Sponsor
- Prometic Biotherapeutics, Inc.
Bullous Pemphigoid
Clinical Trial of NPB-01 in Patients With Bullous Pemphigoid Unresponsive to Corticosteroids.
Patients diagnosed with bullous pemphigoid were confirmed based on the investigators national diagnostic criteria. Patients who meet all inclusion criteria and conflict the exclusion criteria will receive NPB-01(intravenous…
- Trial name
- NPB-01 (NCT00809822)
- Testing
- NPB-01
- Where
- Japan
- Volunteers
- 20 people
- Sponsor
- Nihon Pharmaceutical Co., Ltd
Diffuse Large B-Cell Lymphoma
Combination of SAR3419 and Rituximab in Relapsed/Refractory Diffuse Large B-Cell Lymphoma
Primary Objective: Participants Achieving an Objective Response Rate (Cheson 2007) Secondary Objectives: Progression Free Survival Overall Survival Response Duration
- Trial name
- NCT01470456
- Testing
- SAR3419, rituximab
- Where
- 13 sites in Austria, France and 1 more
- Volunteers
- 50 people
- Sponsor
- Sanofi
Agammaglobulinemia, IgG Deficiency
Safety and Efficacy of Intravenous Immunoglobulin IgPro10 in Patients With Primary Immunodeficiencies (PID)
The objectives of this trial are the assessment of safety and efficacy of IgPro10 in patients with PID, and the assessment of tolerability of high infusion rates.
- Conditions
- Agammaglobulinemia, IgG Deficiency, Common Variable Immunodeficiency
- Trial name
- NCT00322556
- Testing
- Immunoglobulins Intravenous (Human)
- Where
- 10 sites in United States
- Volunteers
- 55 people
- Sponsor
- CSL Behring
Primary Immunodeficiency Diseases
A Study of NewGam, Human Immunoglobulin 10%, in Patients With Primary Immunodeficiency Diseases
The purpose of this study was to determine the efficacy of NewGam in preventing serious bacterial infections and to determine the pharmacokinetic profile of NewGam.
- Trial name
- NCT01012323
- Testing
- NewGam
- Where
- 7 sites in United States
- Volunteers
- 51 people
- Sponsor
- Octapharma
Influenza A H3N2, Influenza A H1N1
Exploring Safety & Clinical Benefit of Anti-Influenza Immunoglobulin Intravenous in Hospitalized Adults With Influenza A
Influenza, or the flu, is an infectious respiratory disease that can range in severity from mild to severe to even death. This study aims to evaluate a treatment for people who are hospitalized with the flu.
- Trial name
- NCT03315104
- Testing
- FLU-IGIV
- Where
- 55 sites in United States, Canada and 2 more
- Volunteers
- 65 people
- Sponsor
- Emergent BioSolutions
Primary Immunodeficiency Disease (PIDD)
Monitoring of 5% Treatment Naïve Intravenous Immunoglobulin (IVIg) Primary Immunodeficiency Disease (PIDD) Patients Using the CareExchange® System: A Pilot Study Using 5% Gammaplex® IVIg in the Home Setting
The purpose of this study is to demonstrate the utility of measuring outcomes in 5% treatment naïve Intravenous Immunoglobulin (IVIg) Primary Immunodeficiency Disease (PIDD) patients using infusion nurse and patient measured…
- Trial name
- NCT02176239
- Where
- 4 sites in United States
- Volunteers
- 20 people
- Sponsor
- BriovaRx Infusion Services
Atherosclerosis
A Study to Evaluate the Safety, Tolerability, and Activity of Intravenous MLDL1278A in Patients on Standard-of-Care Therapy for Stable Atherosclerotic Cardiovascular Disease (GLACIER)
This is a Phase II (proof-of-activity), double-blind, placebo-controlled, randomized, multicenter study of MLDL1278A (also known as BI-204) involving patients on standard-of-care therapy for atherosclerotic cardiovascular disease…
- Trial name
- NCT01258907
- Testing
- MLDL1278A, statin, stable dose
- Where
- 24 sites in United States, Canada
- Volunteers
- 147 people
- Sponsor
- Genentech, Inc.
Kawasaki Disease Refractory to Initial Therapy With Intravenous Immunoglobulin
Clinical Study of TA-650 in Patients With Refractory Kawasaki Disease
The purpose of this study is to evaluate the efficacy and safety of TA-650 in comparison with a control drug Polyethylene Glycol-treated Human Immunoglobulin (VGIH) in patients with Kawasaki disease refractory to initial therapy…
- Trial name
- NCT01596335
- Testing
- TA-650, Polyethylene Glycol-treated Human Immunoglobulin (VGIH)
- Where
- 8 sites in Japan
- Volunteers
- 31 people
- Sponsor
- Tanabe Pharma Corporation