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Gamma Medical Research Studies

Up-to-date List of Gamma Medical Research Studies

What Research is Being Done?

A clinical study involves research using human volunteers (also called participants) that is intended to add to medical knowledge. There are two main types of clinical studies: clinical trials (also called interventional studies) and observational studies. Following list includes both interventional and observational studies.

Latest Gamma Medical Research Studies

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
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

These studies may lead to new treatments and are adding insight into Gamma etiology and treatment.

A major focus of Gamma research is the development of new drugs and other treatment options. Studies seek to identify new drugs to treat various related disorders and to find safer, more effective doses for medications already being used. Other research is aimed at identifying receptors or drug targets.

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