Rank |
Status |
Study |
1 |
Not yet recruiting
|
ASIS for GAMMAGARD in Primary Immunodeficiency
Condition: |
Primary Immunodeficiency |
Interventions: |
Drug: Gadolinium For abdomen; Drug: Gadolinium For lower back; Drug: Efficacy of Gammagard subcutaneously at Week 12; Drug: Efficacy of Gammagard subcutaneously at Week 24; Drug: Efficacy of Gammagard subcutaneously at Week 36; Drug: Efficacy of Gammagard subdermally at Week 36; Drug: Efficacy of Gammagard subdermally at Week 12; Drug: Efficacy of Gammagard subdermally at Week 24; Drug: Adverse Reactions of Gammagard subcutaneously at Week 12; Drug: Adverse Reactions of Gammagard subcutaneously at Week 24; Drug: Adverse Reactions of Gammagard subcutaneously at Week 36; Drug: Adverse Reactions of Gammagard subdermally at Week 12; Drug: Adverse Reactions of Gammagard subdermally at Week 24; Drug: Adverse Reactions of Gammagard subdermally at Week 36 |
Outcome Measures: |
Relative Prolongation Ability Score for Gadolinium subdermally injected; Efficacy of GAMMAGARD subcutaneously vs. subdermally in Primary Immunodeficiency |
|
2 |
Recruiting
|
Bioequivalence Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of Gammaplex® 10 and Gammaplex® 5% in Primary Immunodeficiency Diseases
Conditions: |
Primary Immune Deficiency Disorders; Common Variable Immunodeficiency; X-linked Agammaglobulinaemia; Hyper-IgM Syndrome |
Interventions: |
Biological: Gammaplex (5%); Biological: Gammaplex 10 |
Outcome Measures: |
Primary Bioequivalence analysis - area under the curve within a 28-day dosing interval (AUC0-28) in adult subjects; Secondary Bioequivalence analysis - IgG trough levels; Other pharmacokinetic parameters for IgG; Adverse events; Adverse events - Thrombotic events; Adverse events - product-related AEs; Adverse events - SUSARS; Vital signs; Laboratory testing; Viral transmission; Physical Examination; Tests for hemolysis |
|
3 |
Recruiting
|
A Double-Blind, Placebo Controlled Study of Intravenous Immunoglobulin for HIV-Associated Myelopathy
Condition: |
HIV-associated Myelopathy |
Interventions: |
Drug: Intravenous Immunoglobulin; Drug: Placebo |
Outcome Measures: |
Change in strength scores pre and post treatment; Changes in walking; Changes in urinary and bowel function; Changes in clinical disability |
|
4 |
Not yet recruiting
|
Subconjunctival IVIg (Gamunex-C) Injection for Corneal Neovascularization and Inflammatory Conditions
Conditions: |
Corneal Neovascularization; Corneal Graft Failure; Anterior Segment Inflammation |
Intervention: |
Drug: Gamunex-C |
Outcome Measures: |
Ability to regress neovascularization; Ability to regress neovascularization and promote graft survival; Need for immunosuppression; Effect on corneal infections; Visual outcome at week 28; Visual outcome at week 52; Mean number of injections through week 28; Mean number of injections through week 52; Need for rescue treatment in standard of care group |
|
5 |
Unknown †
|
Intravenous Immunoglobulins in Complex-regional Pain Syndrome
Condition: |
Complex Regional Pain Syndrome Type 1 |
Intervention: |
Biological: intravenous immunoglobulins |
Outcome Measures: |
Change in impairment Level SumScore (ISS); Pain disability score; Quality of life (SF-36); Titer of surface-binding neuronal autoantibodies in the serum; Serum concentration of B-cell activating factors BAFF, APRIL |
|
6 |
Recruiting
|
Octagam 5% Versus Comparator Post Marketing Trial
Condition: |
Primary Immune Deficiency Disorder |
Interventions: |
Biological: Octagam 5%; Biological: Other marketed IVIG product |
Outcome Measure: |
Incidence Rate of Thromboembolytic events |
|
7 |
Recruiting
|
Evaluating the Effectiveness of Intravenous Immunoglobulin Therapy in Autoimmune Autonomic Ganglionopathy
Condition: |
Autoimmune Autonomic Ganglionopathy (AAG) |
Intervention: |
Drug: IVIG |
Outcome Measures: |
The effect of intravenous immunoglobulin (IVIG) study treatment on orthostatic hypotension during head up tilt.; To determine the effects of 12 weeks of intravenous immunoglobulin (IVIG) study treatment on orthostatic hypotension compared to 6 weeks of IVIG.; To determine the effects of 12 weeks of intravenous immunoglobulin (IVIG) study treatment on autonomic symptoms.; To determine the effects of 12 weeks of intravenous immunoglobulin (IVIG) study treatment on Composite Autonomic Severity Score (CASS).; To determine the effects of 12 weeks of intravenous immunoglobulin (IVIG) study treatment on change in quality of life.; To provide a summary of the adverse events after 12 weeks of intravenous immunoglobulin (IVIG). |
|
8 |
Recruiting
|
Evaluation of the Safety and Efficacy of Standard Intravenous Immunoglobulins in Pregnant Women With Primary Cytomegalovirus Infection
Condition: |
Cytomegalovirus Congenital Infection |
Intervention: |
Biological: standard intravenous immunoglobulin |
Outcome Measures: |
Prevention of neurological damage due to Cytomegalovirus congenital infection; Evaluate safety of aspecific immunoglobulins in pregnant women with primary CMV infection |
|
9 |
Recruiting
|
IVIG Treatment in Systemic Sclerosis
Conditions: |
Systemic Sclerosis; Diffuse Scleroderma |
Intervention: |
Biological: Privigen |
Outcome Measures: |
To study the effects of IVIG on the skin in patients with scleroderma; To determine any toxicity of IVIG in scleroderma; To evaluate the effects of IVIG on pulmonary function; Muscle, joint, and inflammatory parameters |
|
10 |
Not yet recruiting
|
Antibiotic Treatment and Intravenous Immunoglobulin Trial for PANDAS
Condition: |
Pandas |
Interventions: |
Drug: Sertraline+Antibiotic (penicillin/azithromycin); Drug: Sertraline+placebo; Biological: IVIG |
Outcome Measures: |
The improvement of OC/tic symptoms will be superior in patients treated with SSRI+AB and in case with IVIG, compared with those treated with SSRI+placebo, as assessed by the YBOCS/YGTSS; The degree of treatment response is expected to correlate with the percentage reduction in antibodies titers following IVIG administration; The degree of treatment response is also expected to correlate with decreased inflammation in specific regions of the brain, as demonstrated by macroscopic changes and microstructural alterations on MRI and serum and CSF cytokines and chemokines |
|
11 |
Unknown †
|
Intravenous Immunoglobulins as Effective Treatment in Sydenham's Chorea
Conditions: |
Sydenham Chorea; Post Streptococcal Movement Disorder |
Interventions: |
Biological: Intravenous immunoglobulin; Drug: standard interventions penicillin VK and haloperidol |
Outcome Measures: |
improved scores on the sydenham chorea assessment charts; improved quality of life |
|
12 |
Not yet recruiting
|
Non-inferiority of Immunoglobulin Anti-RhD KamRho-D® Compared to Rhopphylac® in Postpartum Immunization of Rh-negative, Coombs Negative Women at Risk of Sensitization.
Condition: |
Prevention of Rh Sensitization During Pregnancy |
Interventions: |
Biological: Immunoglobulin Anti-RhD; Biological: Rhophylac |
Outcome Measures: |
The primary endpoint will be the maintenance of the negative result for the indirect Coombs test 06 months after delivery, proving that the test drug and the comparator drug had the same ability to neutralize possible fetal red blood cells.; Incidence, intensity, type and frequence of adverse event. |
|
13 |
Recruiting
|
A Safety Study of Intravenous Immunoglobulin in Patients With Chronic Immune Thrombocytopenic Purpura (ITP)
Condition: |
Immune Thrombocytopenic Purpura |
Intervention: |
Biological: IgPro10 |
Outcome Measures: |
Set of antibodies most frequently bound to red blood cells (RBCs) in subjects experiencing clinically significant intravascular hemolysis; Responder rate |
|
14 |
Unknown †
|
Intravenous Immunoglobulin (IVIG) for Resistant Neuropathic Pain
Condition: |
Neuropathic Pain |
Interventions: |
Biological: Intravenous immunoglobulin; Biological: Normal Saline |
Outcome Measures: |
The primary outcome measure will consist of change in mean daily pain diary score from baseline to each week post-treatment; Measurement of neuroinflammation (NI) markers (IL-1β, IL-6, IL-8, TNF-α, MMP-9, TIMP-1) |
|
15 |
Recruiting
|
Clinical Study of TA-650 in Patients With Refractory Kawasaki Disease
Condition: |
Kawasaki Disease Refractory to Initial Therapy With Intravenous Immunoglobulin |
Interventions: |
Drug: TA-650; Drug: Polyethylene Glycol-treated Human Immunoglobulin (VGIH) |
Outcome Measures: |
Defervescence rate within 48 hours after the start of the study drug administration; Duration of fever; Incidence of coronary artery lesions |
|
16 |
Not yet recruiting
|
A Prospective, Global, Multi-center, Treatment Registry Study of Intravenous Immunoglobulin Maintenance Therapy in Alloantibody Positive Renal Allograft Recipients
Condition: |
Renal Transplant Recipients With Anti-HLA Antibody (DSA) Positivity |
Intervention: |
|
Outcome Measures: |
This trial with evaluate the treatment effect of maintenance intravenous immunoglobulin therapy on graft survival and glomerular filtration rates in renal transplant recipients who present with anti-human leukocyte antigen (HLA) antibodies (DSA).; This trial will provide an estimate of the kinetics of the change in anti-HLA antibodies Class I and/or Class II, as it relates to IVIg therapy response rates. |
|
17 |
Recruiting
|
Intravenous Gammaglobulin for Sickle Cell Pain Crises
Conditions: |
Sickle Cell Disease; Pain |
Interventions: |
Drug: Immune Globulin Intravenous; Drug: Normal saline |
Outcome Measures: |
Duration of pain crisis; Total opioid use in equivalent of mg of IV morphine |
|
18 |
Recruiting
|
Intravenous Immunoglobulin (IVIg) for Parvovirus B19(PVB19) Mediated Cardiomyopathy
Conditions: |
Myocardial Diseases; PVB19 Viral Load |
Interventions: |
Drug: Intravenous Immunoglobulins; Drug: plasma volume expander |
Outcome Measures: |
The main study parameter is the change in cardiac ejection fraction presence of the heart from baseline to endpoint.; Secondary objectives include changes in presence of cardiotrophic viruses, inflammation , fibrosis, cardiac functional capacity, patient quality of life, other echocardiographic parameters. |
|
19 |
Not yet recruiting
|
A Trial of Eltrombopag or Intravenous Immune Globulin Before Surgery for Immune Thrombocytopenia Patients
Condition: |
Immune Thrombocytopenic Purpura |
Interventions: |
Drug: Eltrombopag; Drug: IVIG infusion |
Outcome Measures: |
Proportion of patients achieving the platelet count threshold before surgery and maintaining platelet counts within the target range without the use of ITP rescue treatment.; Time to treatment failure; Bleeding; Proportion of participants who undergo surgery as planned; Treatment satisfaction assessment; Use of blood transfusions; Pre-surgery platelet count change from baseline; Total clinic and hospital days; Venous thromboembolism and arterial thromboembolism; Adverse Events |
|
20 |
Recruiting
|
A Phase 1, Open Label, Ascending Dose Cohort Study of the Pharmacokinetics of Anti-Influenza Hyperimmune Intravenous Immunoglobulin in Healthy Subjects
Conditions: |
Influenza; Flu |
Intervention: |
Drug: Anti-influenza IVIG |
Outcome Measures: |
HAI titer levels predose, at 1 hr post-infusion, and on Days 3, 7, 14 and 28; Type and frequency of adverse events experienced by subjects receiving anti-influenza IVIG by intravenous administration at escalating dose-levels |
|