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Displaying 1 - 48 of 48

LT Inflammation and Immunosuppression Biomarkers

Condition: Transplant / Liver Transplant
Investigator: Yael Nobel, MD, MS
Status: Currently Recruiting
A complication that can occur after liver transplant (LT) is rejection, in which the patient's immune system damages the transplanted liver. Tacrolimus is the primary medication used in most patients to suppress the immune system and prevent this complication after LT. The main purpose of this study is to determine if bacteria in the intestine (gut…
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INTEGRATE Cohort Study

Condition: Transplant / Liver Transplant
Investigator: Elizabeth Verna, MD
Status: Currently Recruiting
The purpose of this observational research study is to identify things that contribute to outcomes in patients with alcohol-associated liver disease who are being considered for liver transplant and who have less than 6 months of sobriety. We will look at many things including images of the liver and heart, blood tests, urine tests, stool tests and liver…
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Cognitive Impairment (Problems with Thinking and Memory) in Liver Disease

Condition: Transplant / Liver Transplant
Investigator: Sloane Heller, MD
Status: Currently Recruiting
The purpose of this study is to understand how liver disease affects thinking and memory, both before and after transplant. Participants will take a cognitive test, which will be a series of tasks and questions similar to a video game, at home on their own computers, tablets, or phones. This will take approximately 45 minutes, and participants will do this…
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Characterizing Alzheimer's Disease & Related Dementias (ADRD) and risk for ADRD among liver transplant recipients with cognitive impairment

Condition: Transplant / Liver Transplant
Investigator: Elizabeth Verna, MD
Status: Currently Recruiting
The main purpose of this study is to deeply characterize cognitive function in liver transplant recipients, differentiate among different causes of cognitive impairment, and identify contributors to cognitive impairment. Participants will receive a comprehensive neurological exam, cognitive assessment, neuropsychological testing, MRI of the brain, and blood…
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SET-SAIL (Siplizumab in patients with AIH undergoing LT)

Condition: Transplant / Liver Transplant
Investigator: Elizabeth Verna, MD
Status: Currently Recruiting
The purpose of this study is to evaluate the safety of siplizumab when used as induction immunosuppression in patients with primary sclerosing cholangitis or autoimmune hepatitis undergoing liver transplantation. Induction immunosuppression drugs are very potent anti-rejection drugs that are given immediately after transplantation to prevent rejection.…
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Functional Assessment in Liver Transplantation (FrAILT) Study

Condition: Transplant / Liver Transplant
Investigator: Elizabeth Verna, MD
Status: Currently Recruiting
The purpose of this study is to learn more about the effects of functional status (also known as "frailty") using a physical test in patients with liver disease on their health outcomes. We are enrolling patients prior to liver transplantation, and will continue to assess their functional status post transplant. If you have any questions regarding…
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Liver Transplant from Donors with HIV for Recipients with HIV: Long Term Follow-up Study (HOPE)

Condition: Transplant / Liver Transplant
Investigator: Marcus Pereira, MD, MPH
Status: Currently Recruiting
The primary objective is to evaluate long-term outcomes in transplant recipients with HIV who receive livers from donors with HIV compared to donors without HIV. If you have any questions regarding this study, please contact the Transplant Clinical Research Center (TCRC).
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Live-Viral Vaccination after Pediatric Liver Transplantation

Condition: Transplant / Liver Transplant
Investigator: Steven Lobritto, MD
Status: Currently Recruiting
In this study, we will collect information from the medical record of pediatric liver transplant recipients who received live vaccines as part of their routine post-transplant care. This data will be combined with data from other centers across the United States and Canada to help give us a better understanding of the safety and efficacy of live vaccines in…
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Organ Care System (OCS) Liver Perfusion (OLP-II) Registry

Condition: Transplant / Liver Transplant
Investigator: Tomoaki Kato, MD
Status: Currently Recruiting
The purpose of this sponsor-initiated multi-center registry is to collect additional data on the performance of the FDA Approved OCS Liver System and post-transplant clinical outcomes for patients who are transplanted with an OCS Liver perfused donor liver in the real-world setting. If you have any questions regarding this study, please contact the…
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CONQUER Registry to Track Disease Progression in Systemic Sclerosis (Scleroderma)

Condition: Autoimmune Disorders
Investigator: Elana Bernstein, MD
Status: Currently Recruiting
The purpose of this study is to develop a cohort of patients with early scleroderma and to collect data on clinical outcomes, radiological tests, laboratory tests, and to obtain biological specimens for testing.
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Genome Research in African American Scleroderma Patients (GRASP Study)

Condition: Autoimmune Disorders
Investigator: Elana Bernstein, MD
Status: Currently Recruiting
This research is being done to determine how variations in genes may explain the different risks to develop scleroderma (or CREST) seen in African American patients compared to other populations. People who are African American with scleroderma (or CREST) may join. This research involves a blood draw and physical exams.
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Studies of Pediatric Liver Transplantation (SPLIT)

Condition: Transplant / Liver Transplant
Investigator: Steven Lobritto, MD
Status: Closed
The purpose of the study is to collect scientific data on pediatric liver transplantation to learn more about how children do after liver transplant. Collecting these data is expected to help researchers learn more about liver transplant in children. This information may improve medical care of your child and other children who need and who have received…
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Understanding the Life Course of Primary Immune Regulatory Disorders (PIRD) Patients and Their Family Members

Condition: Autoimmune Disorders
Investigator: Olatundun Williams, MD
Status: Closed
The purpose of this study is to understand the life course of PIRD patients and their family members that have the same gene change but do not have the same symptoms. PIRD is mostly due to inherited changes in the genes that normally have immune cells fight infections and regulate the immune system. There are many types of problems that patients with PIRD…
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A Study of HIV+ Deceased Donor Liver Transplants for HIV+ Recipients (Liver Transplant)

Condition: Transplant / Liver Transplant
Investigator: Marcus Pereira, MD, MPH
Status: Closed
The primary objective of this study is to determine if an HIV-infected donor liver (HIVD+) transplant is safe with regards to major transplant-related and HIV-related complications. This study will evaluate if receiving a liver transplant from an HIV-infected deceased liver donor is safe with regards to survival and major transplant-related and HIV-related…
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Adipose Inflammation in Rheumatoid Arthritis - AIR ART (RA Treatment Arm)

Condition: Autoimmune Disorders / Rheumatoid Arthritis
Investigator: Jon Giles, MD
Status: Closed
We are inviting patients with active Rheumatoid Arthritis (RA) to help us better understand how treatment options affect inflammation in soft tissues. With a combination of blood work, a full-body FDG PET-CT scan, questionnaires, and a soft tissue biopsy (from an area around the belly button), we hope to see how RA interacts with these multiple areas of…
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PsA-FAT

Condition: Autoimmune Disorders
Investigator: Jon Giles, MD
Status: Closed
We are looking for patients who have been diagnosed with Psoriatic Arthritis (PsA) to help us better understand the involvement of inflammation on the body. With a combination of bloodwork, a bone density scan, questionnaires, and a one-time soft tissue biopsy (from an area around the belly button), we hope to see how PsA interacts with these multiple areas…
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Nivolumab in Treating Patients With Autoimmune Disorders and Advanced, Metastatic, or Unresectable Cancer

Condition: Autoimmune Disorders
Investigator: Brian Henick, MD
Status: Closed
This phase Ib trial studies the side effects of nivolumab and to see how well it works in treating patients with autoimmune disorders and cancer that has spread to other places in the body or cannot removed by surgery. Immunotherapy with monoclonal antibodies, such as nivolumab, may help the body's immune system attack the cancer, and may interfere…
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Solutions for Celiac Study

Condition: Autoimmune Disorders
Investigator: Peter Green, MD
Status: Closed
This research study is sponsored by ImmunogenX and The National Institutes of Health (NIH, Bethesda, MD). The objective of this study is to determine if the investigational product (latiglutenase) will help decrease symptoms in subjects with celiac disease while maintaining a gluten-free diet while undergoing periodic gluten exposure. In addition, this…
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Bone Structure in Men with Celiac Disease

Condition: Autoimmune Disorders
Investigator: Marcella Walker, MD
Status: Closed
Celiac disease is associated with an increased risk of osteoporosis and fractures. Men with celiac disease were found to be at higher risk for metabolic bone disease compared to women with celiac disease. The mechanisms underlying metabolic bone disease in celiac disease remain incompletely understood. The goal of this study is to assess skeletal…
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Effects of Abatacept on Heart Inflammation in Rheumatoid Arthritis (AMiRA)

Condition: Autoimmune Disorders / Rheumatoid Arthritis
Investigator: Laura Geraldino-Pardilla, MD, MPH
Status: Closed
This study aims to understand how two commonly prescribed drugs impact myocardial inflammation in rheumatoid arthritis.
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Double-blind trial to Test Efficacy of Rituxan (Rituximab) on Systemic Sclerosis-Associated Pulmonary Arterial Hypertension

Condition: Autoimmune Disorders
Investigator: Elana Bernstein, MD
Status: Closed
Systemic sclerosis (SSc) is a systemic connective tissue disease characterized by fibrosis and atrophy, namely of the skin, internal organs, joints, and skeletal muscles. There are numerous manifestations of SSc that affect multiple organ systems. The major pulmonary manifestations of SSc, interstitial lung disease and systemic sclerosis-associated…
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Treatments Against RA and Effect on FDG PET-CT: The TARGET Trial

Condition: Autoimmune Disorders / Rheumatoid Arthritis
Investigator: Joan Bathon, MD
Status: Closed
The study aims to compare the effect two different RA treatments on cardiovascular health in patients who are considering a treatment change. The study is recruiting patients who are only taking methotrexate and are switching treatment due to a lack of improvement. The trial will randomize participants to take a TNF inhibitor (Enbrel or Humira) in addition…
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A study for patients with systemic sclerosis using study drug abituzumab

Condition: Autoimmune Disorders
Investigator: Elana Bernstein, MD
Status: Closed
The purpose of this study is to determine the effectiveness and safety of a study drug called abituzumab in subjects with systemic sclerosis-associated interstitial lung disease (SSc-ILD). The study will also look at the following: How the study drug affects other symptoms of SSc-ILD -How safe the study drug is (i.e. if there are any side effects) -How the…
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Study for adult liver transplant recipients with chronic Hepatitis C infection using study drug (ABT-450/r/ABT-267)

Condition: Transplant / Liver Transplant
Investigator: Robert Brown, MD, MPH
Status: Closed
The purpose of this study is to see if study drugs ABT-450/r/ABT-267, and ABT-333 taken with RBV are safe and able to reduce the amount of Hepatitis C Virus (HCV) in subjects' blood over a 24-week treatment period. These drugs are intended to prevent the HCV from multiplying in the human body. Subjects who participate in this study will be expected to…
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A study for patients with Lupus Nephritis using ACTHAR GEL

Condition: Autoimmune Disorders / Lupus
Investigator: Wooin Ahn, MD
Status: Closed
The purpose of this study is to determine if Acthar gel is a safe and effective therapy for patients with membranous (Class V) lupus nephritis. Class V lupus nephritis is associated with the development of chronic kidney disease and end-stage renal (kidney) disease, and there is no clear therapy for treatment. Currently used therapies arent completely…
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Rheumatoid Arthritis Study - RHYTHM Renewal

Condition: Autoimmune Disorders / Rheumatoid Arthritis
Investigator: Joan Bathon, MD
Status: Closed
We are doing a research study to learn more about why people with rheumatoid arthritis (RA) are prone to heart disease. We are recruiting patients diagnosed with Rheumatoid Arthritis without a personal history of heart disease. This study involves one initial full visit as described below, and a brief follow up visit that will take place approximately 2 or…
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A study for patients with lupus nephritis using the study drug Obinutuzumab.

Condition: Autoimmune Disorders / Lupus
Investigator: Anca Askanase, MD, MPH
Status: Closed
The purpose of this study is to test the safety and effectiveness of the study drug Obinutuzumab and to find out what effects, good or bad, it may have as an additional therapy in treating your lupus nephritis symptoms.
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AURORA Study: Iloprost for Subjects with Systemic Sclerosis (SSc-Raynaud's Phenomenon)

Condition: Autoimmune Disorders
Investigator: Elana Bernstein, MD
Status: Closed
The purpose of this study is to find out whether a drug called iloprost is safe to use in people with systemic sclerosis (SSc) (Raynaud's phenomenon), and whether it may help decrease symptomatic digital ischemic episodes (episodes in the fingers).
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Study of Fibrosis in Liver Transplant Recipients with Chronic Hepatitis C

Condition: Transplant / Liver Transplant
Investigator: Robert Brown, MD, MPH
Status: Closed
The purpose of this study is to determine if the administration of non-absorbable antibiotics (rifaximin) for the first three months after liver transplant period will reduce the amount of fibrosis (scarring of the liver) in liver transplant patients with hepatitis C virus (HCV) by lowering serum LPS (a protein in the blood that comes from the bacteria in…
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A study on subjects with systemic lupus erythematosus using study drug CC-220

Condition: Autoimmune Disorders / Lupus
Investigator: Anca Askanase, MD, MPH
Status: Closed
This study is for patients who have been diagnosed with systemic Lupus erythematosus (SLE). SLE is a disease in which the body mistakenly attacks healthy tissue. It can affect the skin, joints, kidneys, brain and other organs. The purpose of this study is to test the effects of an investigational (being tested) study drug, CC 220, in order to find out if CC…
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A study for pediatric patients with Systemic Lupus Erythematosus (SLE) using study drug Belimumab

Condition: Autoimmune Disorders / Lupus
Investigator: Lisa Imundo, MD
Status: Closed
The purpose of the study is to find out if study drug belimumab is safe and effective in treating children with active lupus who are also taking other lupus medicine. Belimumab (also known as BENLYSTA hasbeen approved in the United States, Canada, and Europe for the treatment of adults with active SLEwho are receiving other lupus medicines but not yet…
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Study to evaluate the safety and effectiveness of Fibrin sealant during open surgeries

Condition: Transplant / Liver Transplant
Investigator: Tomoaki Kato, MD
Status: Closed
The purpose of this study is to evaluate the safety and efficacy of FS Grifols as an adjunct to hemostasis during parenchyomous tissue open surgical procedures. Baseline assessments will be performed within 24 hours prior to the scheduled surgery. There will be a physical assessment and a blood draw at the first study visit. Subjects will be randomly…
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Study to Evaluate Performance of LifePort Liver Transporter System, a Machine Perfusion System, for Liver Transplant (PILOT)

Condition: Transplant / Liver Transplant
Investigator: Adam Griesemer, MD
Status: Closed
This is a prospective, randomized, multi-center, controlled study for subjects with end stage liver disease who require a liver transplant, comparing whole liver preservation via hypothermic machine perfusion (HMP) using the LLT System with Vasosol with livers preserved via static cold storage (which is standard of care). During Hypothermic Machine…
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A study for subjects with Lupus nephritis using an oral study drug MLN9708

Condition: Autoimmune Disorders / Lupus
Investigator: Anca Askanase, MD, MPH
Status: Closed
The purpose of this study is to evaluate the safety and tolerability of an experimental investigational drug called ixazomib citrate (MLN9708) in patient with Lupus Nephritis. Lupus nephritis is a condition when the kidney is affected in the autoimmune disease known as systemic lupus erythematosus (SLE). SLE is a disease in which the immune system (the body…
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A study for patients with Systemic Lupus Erythematosus using study drug ALX-0061

Condition: Autoimmune Disorders / Lupus
Investigator: Anca Askanase, MD, MPH
Status: Closed
The goal of this study is to test a new lupus drug. This drug interrupts the function of a chemical in the body called IL-6, and IL-6 may be overactive in people with lupus. ALX-0061 is a study drug that will be administered subcutaneously to subjects with moderate to severe active, seropositive Systemic Lupus Erythematosus (SLE) compared to placebo.
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A study for subjects with liver cancer using a drug to prevent recurrence of liver cancer following liver transplantation

Condition: Transplant / Liver Transplant
Investigator: Tomoaki Kato, MD
Status: Closed
The purpose of this study is to determine if Nexavar (sorafenib), the study medication, is effective in preventing cancer recurrence in high risk patients following liver transplantation. The purpose of this study is to determine if sorafenib is a safe and effective treatment option for preventing the recurrence of liver cancer in high risk subjects…
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A study for liver transplant patients with Chronic HCV using study drug Harvoni

Condition: Transplant / Liver Transplant
Investigator: Elizabeth Verna, MD
Status: Closed
The purpose of this study is to see if the study drug Harvoni given for 4 weeks immediately after liver transplantation is safe and able to clear the Hepatitis C virus (HCV) from the body. This study will test a drug named Harvoni for the treatment of chronic genotype 1 or 4 Hepatitis C Virus (HCV) in peri-operative liver transplant patients. Harvoni (LDV/…
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Abituzumab for patients with SSc-ILD taking mycophenolate

Condition: Autoimmune Disorders
Investigator: Elana Bernstein, MD
Status: Closed
The purpose of this study is to determine the efficacy and safety of abituzumab in subjects withsystemic sclerosis-associated interstitial lung disease (SSc-ILD).Abituzumab is an investigational drug that is being evaluated for the treatment of patients withsystemic sclerosis (SSc)-associated interstitial lung disease (SSc-ILD). Systemic sclerosis,…
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A study for patients with Lambert-Eaton Myasthenic Syndrome (LEMS) using study drug Amifampridine Phosphate

Condition: Autoimmune Disorders
Investigator: Thomas Brannagan, MD
Status: Closed
This study is for patients with Lambert-Eaton Myasthenic Syndrome (LEMS). The purpose of this study is to provide doctors and their patients access to amifampridine phosphate therapy for their patients with LEMS, CMS or downbeat nystagmus until the product becomes commercially available. The secondary purpose of the study is to assess the long-term safety…
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Study of Experimental Gel Drug in Subjects with Persistently Active Systemic Lupus Erythematosus (SLE)

Condition: Autoimmune Disorders / Lupus
Investigator: Anca Askanase, MD, MPH
Status: Closed
We are studying a medication to see if it is effective in reducing the disease activity of systemic lupus erythematosus (SLE), which is the most common form of lupus. You may qualify for the Achtar study if you have persistently active SLE, are 18 years of age or older, and: Have rash and/or arthritis as part of your SLE symptoms Are currently taking…
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A study of liver transplant recipients to evaluate renal function, effectiveness and safety of a study drug, everolimus

Condition: Transplant / Liver Transplant
Investigator: Tomoaki Kato, MD
Status: Closed
The purpose of this study is to investigate a new therapeutic regimen with or without steroids in the pediatric population. The aim is to find out whether everolimus is safe and has beneficial effects in children who receive a liver transplant. All children will receive a study drug called everolimus twice a day plus a reduced dose of cyclosporine or…
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A study for patients with lupus using the study drug XmAb5871.

Condition: Autoimmune Disorders / Lupus
Investigator: Anca Askanase, MD, MPH
Status: Closed
The purpose of this clinical trial is to learn about the ability of an experimental treatment XmAb5871 to maintain lupus disease activity improvement achieved by a brief course of disease-suppressing intramuscular (IM) steroid therapy in lupus patients.
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A study for kidney transplant subjects using study drug eculizumab to prevent delayed graft function

Condition: Transplant / Liver Transplant
Investigator: Lloyd Ratner, MD, MPH, FACS
Status: Closed
The purpose of this study is to determine if eculizumab is safe and could be used to prevent Delayed Graft Function (DGF) following kidney transplantation. DGF is an early complication of kidney transplantation. This condition occurs when the transplanted kidney does not recover instantly after transplantation and can take days to weeks before recovering…
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A Study Evaluating Abatacept (Orencia) for Treatment of Systemic Sclerosis

Condition: Autoimmune Disorders
Investigator: Elana Bernstein, MD
Status: Closed
Systemic sclerosis (SSc) is a systemic connective tissue disease characterized by fibrosis and atrophy, namely of the skin, internal organs, joints, and skeletal muscles. This is a double-blind, placebo-controlled trial to test the efficacy of abatacept (Orencia) on the treatment of diffuse cutaneous systemic sclerosis in patients with a disease duration of…
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NSAIDs in Ankylosing Spondylitis

Condition: Autoimmune Disorders
Investigator: Runsheng Wang, MD
Status: Closed
This is a 6-week randomized, double-blind trial of 4 different non-steroidal anti-inflammatory drugs in patients with axial spondyloarthritis to compare the change of pain score from baseline at 4 weeks to the change of pain score from baseline at 6 weeks. Patients with ankylosing spondylitis or axial spondyloarthritis who fulfills the inclusion and…
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A study for patients with Lupus using study drug ustekinumab

Condition: Autoimmune Disorders / Lupus
Investigator: Anca Askanase, MD, MPH
Status: Closed
If you have active Systemic Lupus Erythematosus, also known as SLE or Lupus, you may be interested to learn about a clinical research study that is being conducted to study the safety and effectiveness of an investigational medication called ustekinumab for active Lupus. Eligible study participants will be provided with study medication and study-related…
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Study for liver transplant recipients using drug (IgG) to prevent Hepatitis C virus (HCV) recurrence

Condition: Transplant / Liver Transplant
Investigator: Elizabeth Verna, MD
Status: Closed
The purpose of this study is to test the safety of different doses of HCIG when given to patients with HCV who receive a liver transplant. It will also provide information about whether HCIG can prevent HCV infection. Participation in the study is expected to last about 10 months. Participants will be randomly assigned to either receive HCIG or not. Your…
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A study for patients with lupus nephritis, using an investigational treatment design with rituximab, cyclophosphamide, and solumedrol

Condition: Autoimmune Disorders
Investigator: Anca Askanase, MD, MPH
Status: Closed
In this experimental study, researchers will try to find out if treatment of lupus nephritis with a combination of rituximab and cyclophosphamide (CTX), or a combination of rituximab and CTX followed by treatment with belimumab is safe and if this drug combination can block the immune system attacks.
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