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Infusion Site Reaction Medical Research Studies

Up-to-date List of Infusion Site Reaction 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 Infusion Site Reaction Medical Research Studies

Rank Status Study
1 Recruiting European, Open-label, Prospective, Multinational, Multicenter Study in Adult Subjects With Type 1 or Type 2 Diabetes Previously on MDI or CSII Therapy. Subjects Home Setting is Considered Routine Practice.
Condition: Type 2 Diabetes, Type 1 Diabetes
Intervention: Device: Accu-Chek® Insight Insulin Pump
Outcome Measures: The primary objective is to evaluate the Accu-Chek Insight Insulin Pump and associated pump devices in routine practice. This will be expressed by the rate of error messages per 100 patient years (confirmed by pump uploads).;   Evaluate type and frequency of adverse events (serious/non-serious) possibly related or related to study devices and/or study procedures;   Evaluate subject satisfaction based on surveys of important factors of health-related quality of life;   Evaluate change in HbA1c from screening to month 3 and 6;   Evaluate utilization of pump functions (e.g. basal rate profiles, temporary basal rates, bolus types);   Evaluate change in CGM-derived parameters from month 3 to month 6;   Evaluate type and frequency of pump signals, i.e. reminders, errors, warnings, alarms, maintenance messages
2 Recruiting A Pilot Study of Zavesca® in Patients With Pompe Disease and Infusion Associated Reaction
Conditions: Pompe Disease;   Hypersensitivity Reaction
Interventions: Procedure: Blood collection for anti-GAA antibody level;   Procedure: Punch Muscle Biopsy;   Behavioral: Survey;   Drug: Zavesca® 100 mg;   Drug: Zavesca® 300 mg
Outcome Measures: Evaluate Pharmacodynamics of ERT with pre-medication Zavesca;   Evaluate pharmacokinetics of ERT with pre-medication Zavesca®;   Evaluate biodistribution of ERT with pre-medication Zavesca®.
3 Unknown  Evaluation of Efficacy and Tolerability of Hizentra®
Condition: Primary Immunodeficiency Disorders
Intervention: Drug: Hizentra
Outcome Measures: To measure the changes in the Treatment Satisfaction Questionnaire for Medication in PIDD subjects transitioning from subcutaneous Vivaglobin® to Hizentra®.;   To compare the incidence of local site reactions in subjects self-infusing with Vivaglobin® transitioning to Hizentra®.;   To compare the steady state IgG levels in subjects self-infusing with Vivaglobin® transitioning to Hizentra®.
4 Not yet recruiting Pharmacokinetics and Optimal Dose of Ertapenem in Hemodialysis Patients
Condition: End Stage Renal Disease
Intervention: Drug: Ertapenem
Outcome Measures: Mean maximum concentration (Cmax) of ertapenem in hemodialysis patients;   Mean minimum concentration (Cmin) of ertapenem in hemodialysis patients;   Mean area under the curve (AUC) of ertapenem in hemodialysis patients;   Mean terminal elimination rate constant (ke) of ertapenem in hemodialysis patients;   Mean terminal half life (t1/2) of ertpenem in hemodialysis patients;   Mean time to Cmax of ertapenem in hemodialysis patients;   Number of participants with diarrhea;   Number of participants with nausea and vomiting;   Number of participants with headache;   Number of participants with injection site reaction
5 Recruiting Management Of The Infusion-Associated Reactions In RRMS Patients Treated With LEMTRADA
Condition: Relapsing-remitting Multiple Sclerosis
Interventions: Drug: alemtuzumab GZ402673;   Drug: H1 antagonist;   Drug: H2 antagonist;   Drug: methylprednisolone;   Drug: aciclovir
Outcome Measures: Proportion of IARs that are graded mild according to the Common Toxicity Criteria (CTC). An IAR is any adverse event occurring during or within 24 hours of LEMTRADA infusion.;   Proportion of IARs;   Proportion and type of serious IARs;   Proportion by type (as defined by clinical symptoms)
6 Recruiting Donor-Alloantigen-Reactive Regulatory T Cell (darTregs) in Liver Transplantation
Condition: Liver Transplantation
Interventions: Biological: Anti-Thymocyte Globulin - Rabbit;   Biological: darTreg Infusion;   Drug: Everolimus;   Drug: Tacrolimus;   Drug: Mycophenolate mofetil;   Drug: Prednisone;   Drug: Acetaminophen;   Drug: Diphenhydramine;   Drug: Anti-Infective Prophylaxis;   Procedure: Leukapheresis;   Procedure: Blood draws;   Procedure: Liver biopsies;   Procedure: Liver transplantation
Outcome Measures: Incidence and severity of biopsy proven acute and/or chronic rejection;   Incidence of Grade 3 or higher infections;   Incidence of Grade 3 or higher wound complications;   Incidence of anemia, neutropenia, and/or thrombocytopenia;   Incidence of adverse events attributable to the darTreg infusion including infusion reaction / cytokine release syndrome, and malignant cellular transformation
7 Recruiting Study of Safety of Elotuzumab Administered Over Approximately 60 Minutes in Combination With Lenalidomide and Dexamethasone for Newly Diagnosed or Relapsed/Refractory Multiple Myeloma Patients
Condition: Multiple Myeloma
Interventions: Drug: Elotuzumab;   Drug: Lenalidomide;   Drug: Dexamethasone
Outcome Measures: Estimating the incidence of G3/4 infusion reactions by the end of Cycle 2: The number and percentage of treated patients with G3/4 infusion reactions by the end of Cycle 2;   Estimate the incidence of any grade and G3/4 infusion reactions on-study: the number and percentage of treated patients with G3/4 infusion reactions during the entire study period
8 Not yet recruiting The Application of Target Controlled Infusion of Etomidate Combined With Propofol in the Maintenance of Anesthesia During Brain Surgeries
Conditions: Target Controlled Infusion;   General Anesthesia
Interventions: Drug: propofol;   Drug: etomidate
Outcome Measures: Heart rate;   Blood pressure;   Concentration of cortisol;   Use of vasoactive agent;   The time from stop of remifentanil to awake;   Severity of agitation;   Postoperative nausea and vomiting;   Dose of etomidate and propofol;   Intraoperative awareness;   Expense of anesthetics;   Allergic reaction
9 Recruiting Standard Infusion Carboplatin Versus Prophylactic Extended Infusion Carboplatin in Patients With Patients With Recurrent, Ovary, Fallopian Tube, and Primary Peritoneal Cancer
Conditions: Ovarian Cancer;   Fallopian Tube Cancer;   Peritoneal Cancer
Intervention: Drug: carboplatin
Outcome Measures: To determine if patients have lower rates of hypersensitivity reactions compared to those treated with standard infusion carboplatin.;   Determine the rate of successful planned treatment completion of carboplatin in each group;   Perform a cost-identification analysis of extended infusion carboplatin to estimate the cost per hypersensitivity reaction prevented.;   Perform exploratory analyses to correlate hypersensitivity rate to history of atopy, prior drug allergies, number of lifetime platinum cycles, duration since last platinum, and concomitant chemotherapy agent.
10 Recruiting Dilated cardiomYopathy iNtervention With Allogeneic MyocardIally-regenerative Cells (DYNAMIC)
Conditions: Dilated Cardiomyopathy (DCM);   Ischemic Cardiomyopathy;   Nonischemic Cardiomyopathy;   Heart Failure
Intervention: Biological: Allogeneic Cardiosphere-Derived Cells (CDCs)
Outcome Measures: Proportion of subjects that experience new TIMI flow 0-2 or TIMI myocardial perfusion grade (TMPG) 0-2.;   Proportion of subjects that experience acute myocarditis, possibly attributable to CAP-1002. In order to be considered related to CAP-1002, humoral or cellular or immune reaction specific to CAP-1002 must also be documented.;   Proportion of subjects that experience ventricular tachycardia or ventricular fibrillation resulting in death, appropriate discharge of an ICD or requiring medical intervention.;   Proportion of subjects that experience sudden unexpected death occurring within one hour of symptom onset, or un-witnessed death in a person previously observed to be well within the preceding 24 hours without an identified cause.;   Proportion of subjects that experience major adverse cardiac events (MACE), including death, non-fatal myocardial infarction and re-hospitalization for cardiovascular event (including heart failure hospitalizations).;   Acute myocarditis possibly attributable to CAP-1002. In order to be considered related to CAP-1002, humoral or cellular immune reaction specific to CAP-1002 must also be documented.;   Ventricular tachycardia or ventricular fibrillation resulting in death or requiring medical intervention or appropriate discharge of an ICD.;   Sudden unexpected death defined as occurring within one hour of symptom onset, or unwitnessed death in a person previously observed to be well within the preceding 24 hours without an identified cause.;   Major adverse cardiac events (MACE), including death, non-fatal myocardial infarction, hospitalization for cardiovascular event, emergency room treatment for heart failure, left ventricular assist device or heart transplant.;   Any hospitalization due to a cardiovascular cause or related to CAP-1002 (or placebo in Phase Ib).;   Any inter-current cardiovascular illness or one related to CAP-1002 (or placebo in Phase Ib) which prolongs hospitalization.;   Development of, or an increase in the frequency of, VT with a duration of 30 seconds or longer ascertained by protocol-mandated ECG ambulatory monitoring.;   Development of increased anti-Human Leukocyte Antigen (HLA) antibody levels with development of sensitization to HLA antigens specific to the CAP-1002 CDC donor at immunologically significant titers.;   Total number of appropriate ICD firings.;   Peak elevation in troponin and CKMB levels following CAP-1002 or placebo infusion.
11 Recruiting Slowed Carboplatin Infusion for Ovarian Cancer Patients Receiving Carboplatin Re-Treatment
Conditions: Recurrent Ovarian Cancer;   Platinum Sensitive Ovarian Cancer
Intervention: Drug: Carboplatin
Outcome Measures: To determine the frequency of carboplatin infusion reactions using a slowed carboplatin infusion program;   To characterize the nature and symptoms of carboplatin reactions associated with the slowed infusion protocol.
12 Recruiting NeoGAA Extension Study
Condition: Glycogen Storage Disease Type II Pompe Disease
Intervention: Drug: GZ402666
Outcome Measures: Assessment of adverse events (AEs) and treatment-emergent adverse events (TEAEs), including infusion-associated reactions (IARs) and deaths;   Laboratory assessments including hematology, biochemistry and urinalysis;   Vital signs;   Electrocardiogram;   anti-neoGAA immunoglobulin G (IgG) antibodies, and neutralizing antibody formation in IgG seropositive patients; anti-alglucosidase alfa IgG antibodies;   Cmax;   AUC;   t1/2;   Skeletal muscle glycogen content;   Skeletal muscle magnetic resonance images for qualitative and quantitative muscle degenerative assessments;   Urinary Hex4;   plasma analyses of circulating mRNA and micro RNA;   serum analyses of skeletal muscle RNA expression
13 Recruiting Infusion of Cell Populations From Unlicensed Umbilical Cord Blood Units
Conditions: Lymphatic Diseases;   Hematopoietic Malignancy
Intervention: Biological: Umbilical Cord Blood (UCB)
Outcome Measures: Incidence of Blood Borne Pathogen Transmission from Unlicensed UCB Units.;   Incidence of Serious Infusion Reactions of Minimally Manipulated Unlicensed UCB Units;   Number of the Desired Lineage Specific Cells in Minimally Manipulated Unlicensed UCB Units;   Incidence of Mislabeled UCB Units;   Comparison of Specific Cord Blood Banks (CBBs)
14 Recruiting Phase IIIB-IV Long-Term Follow-up Study for Patients Who Participated in CAMMS03409
Condition: Relapsing Remitting Multiple Sclerosis
Intervention: Drug: alemtuzumab GZ402673
Outcome Measures: Incidence, duration, grade/intensity, relationship to study drug, and outcome of the following: Serious Adverse Events; Adverse Events;   Incidence, nature, seriousness, grade/intensity, relationship to study drug, and outcome of the following adverse events of special interest: Specific autoimmune mediated conditions, Infusion-associated reactions, Malignancy, Infections;   Changes in laboratory parameters;   Annualized relapse rate (AR);   Proportion of participants relapse free;   Change over time in Expanded Disability Status Scale (EDSS) scores;   Change over time in brain imaging findings;   Change over time in self-reported quality of life (QoL) as assessed by the Medical Outcome Study (MOS) 36-Item Short-Form Health Survey (SF-36) Version 2;   Change over time in the Functional Assessment of Multiple Sclerosis (FAMS);   Change over time in the EuroQoL in 5 Dimensions (EQ-5D);   Pharmaco-economic evaluation (Modify Health Resources Utilization Questionnaire [HRUQ] / Health Related Productivity Questionnaire [HRPQ])
15 Recruiting Rotational Thromboelastography Study in Tranexamic Acid and Colloid Infusion
Conditions: Avascular Necrosis of Femoral Head;   Degenerative Arthritis of Hip
Intervention: Drug: Tranexamic Acid
Outcome Measures: Rotational thromboelastography;   Hemoglobin;   Platelet;   International normalized ratio of prothrombin time;   Activated partial thromboplastin time;   Fibrinogen
16 Recruiting Phase II Study of Alisertib Therapy for Rhabdoid Tumors
Conditions: Malignant Rhabdoid Tumor;   Atypical Teratoid Rhabdoid Tumor
Interventions: Drug: alisertib;   Drug: methotrexate;   Drug: cisplatin;   Drug: carboplatin;   Drug: cyclophosphamide;   Drug: etoposide;   Drug: topotecan;   Drug: vincristine;   Procedure: Surgical resection;   Radiation: Radiation therapy
Outcome Measures: Sustained response rate of pediatric participants with recurrent or refractory ATRT treated with alisertib (stratum A1);   Sustained response rate of pediatric participants with recurrent or refractory MRT treated with alisertib (stratum A2);   3-year progression free survival rate (stratum B1);   1-year progression free survival rate (stratum B2);   3-year progression free survival rate (stratum C1);   1-year progression free survival rate (stratum C2);   Single dose and steady state pharmacokinetics and pharmacodynamics of alisertib;   Duration of objective response by stratum A1 and A2;   1-year progression-free survival (PFS) by stratum A1 and A2;   5-year Progression-free survival (PFS) rate in patients with newly diagnosed ATRT (strata B1, B2, B3, C1, C2);   5-year Overall survival (OS) rate in patients with newly diagnosed ATRT (strata B1, B2, B3, C1, C2);   Proportion of local and distant failure in strata B1, B2, B3, C1 and C2
17 Recruiting Neurotoxicity Characterization Study of Nab-paclitaxel Versus Conventional Paclitaxel in Metastatic Breast Cancer
Condition: Breast Cancer
Interventions: Drug: Paclitaxel 80 mg/m2;   Drug: Nab-paclitaxel 100 mg/m2 days 1, 8 and 15;   Drug: Nab-paclitaxel 150 mg/m2 days 1, 8 and 15;   Drug: Nab-paclitaxel 150 mg/m2 days 1 and 15
Outcome Measures: TNS - Total Neuropathy Score;   Evaluate the incidence of neuropathy induced by study treatment (conventional paclitaxel vs nab-paclitaxel);   Evaluate the electromyographic abnormalities and the correlation of these alterations with the assessment of the TNS scale and NCI-CTCAE (Common Toxicity Criteria for Adverse Effects) v4.0;   Determine the predictive value of genetic variants (SNPs) for the development of neuropathy;   Determine the clinical activity of both treatments (response rate, time to progression);   Determine toxicity profile and safety of study treatments (NCI-CTCAE v4.0);   Determine time to neurotoxicity onset;   Determine time to recovery from neurotoxicity;   Determine time to progression;   Assess quality of live (EORTC QLQ-C30 and EORTC QLQ-CIPN20)
18 Recruiting A Phase III Study of 2nd-line XELIRI ± Bevacizumab vs. FOLFIRI ± Bevacizumab in mCRC
Conditions: Colorectal Neoplasms;   Neoplasm Metastasis;   Intestinal Neoplasms;   Gastrointestinal Neoplasms;   Digestive System Neoplasms
Interventions: Biological: Bevacizumab;   Drug: CPT-11 (Irinotecan);   Drug: 5-FU Bolus;   Drug: 5-FU Infusion;   Drug: l-LV (dl-LV);   Biological: bevacizumab;   Drug: Capecitabine
Outcome Measures: Overall survival;   Progression-free survival (PFS);   Time to treatment failure (TTF);   Overall Response Rate (ORR);   Disease Control Rate (DCR);   Relative Dose Intensity;   Incidence of Adverse Events (Adverse Reactions);   Correlation between UGT1A1 genotype and safety
19 Recruiting Bevacizumab and Trabectedin +/- Carboplatin in Advanced Ovarian Cancer
Condition: Ovarian Epithelial Cancer Recurrent
Interventions: Drug: bevacizumab and trabectedin;   Drug: bevacizumab, trabectedin and carboplatin
Outcome Measures: Progression Free Survival at 6 months (PFS-6);   Proportion of patients with severe toxicity within 6 months from randomization.;   Progression Free Survival (PFS);   Overall survival at 12 months (OS-12);   Clinical Benefit (CB);   Incidence of Adverse Events (AEs);   Maximum toxicity grade;   Percentage of patients experiencing grade 3-4 toxicity for each specific toxicity;   Patients with at least a Serious Adverse Drug Reaction (SADR);   Patients with at least a Suspect Unexpected Serious Adverse Reaction (SUSAR).;   Percentage of patients with dose and/or time modifications;   Percentage of premature withdrawals;   Patients with at least a Serious Adverse Event (SAE);   Nature of AEs;   Severity of AEs;   Seriousness of AEs
20 Recruiting A Study of Prasugrel in Pediatric Participants With Sickle Cell Disease (SCD)
Condition: Sickle Cell Disease
Interventions: Drug: Prasugrel;   Drug: Placebo
Outcome Measures: Number of Vaso-Occlusive Crisis (VOC) Events per Participant per Year (Rate of VOC);   Monthly Rate of Days with Pain;   Monthly Mean in Faces Pain Scale-Revised Score;   Number of Painful Crisis Events per Participant per Year (Rate of Painful Crisis);   Number of Hospitalizations for VOC per Participant per Year (Rate of Hospitalizations);   Number of Acute Chest Syndrome per Participant per Year (Rate of Acute Chest Syndrome);   Number of Red Blood Cell (RBC) Transfusions due to SCD per Participant per Year (Rate of RBC Infusions);   Monthly Rate of Days of Analgesic Use;   Quarterly Rate of School Absence due to Sickle Cell Pain;   Percentage of Participants with Transient Ischemic Attack (TIA)/Ischemic Stroke;   Number of Days Hospitalized for VOC;   Time from Randomization to First and Second VOC;   Percentage of Participants with Hemorrhagic Events Requiring Medical Intervention

These studies may lead to new treatments and are adding insight into Infusion Site Reaction etiology and treatment.

A major focus of Infusion Site Reaction 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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