The purpose of this research study is to determine whether rosuvastatin is safe and can help people living with cirrhosis lead longer, healthier lives. The study drug, rosuvastatin, is investigational, meaning it has not yet been approved for market use for this disease condition by the United States Food and Drug Administration (FDA). Participants will…
The DROP-AKI Trial is studying whether droxidopa, an FDA-approved medication for low blood pressure, can help patients with liver cirrhosis who develop kidney problems during hospitalization. Although droxidopa is FDA-approved for certain types of low blood pressure, it is not approved to treat patients with cirrhosis of the liver who develop kidney injury…
We are conducting a research study on the effect of high insulin levels on the buildup of excessive liver fat ("fatty liver disease") in people at risk for type 2 diabetes. We are seeking adult volunteers, ages 18-65, who have obesity with a body mass index of 30-45, and have been diagnosed with, or are at risk for, prediabetes and metabolic…
This study is examining how oral vancomycin, an antibiotic sometimes used to treat Primary Sclerosing Cholangitis (PSC), affects the bacteria living in the gut (the microbiome). The study is observational, meaning it does not alter medical care or prescribe treatment-participants will continue their usual therapy as decided by their doctors. The study will…
The purpose of this study is to learn about the causes of non-alcoholic fatty liver disease (NAFLD). This is the most common type of liver disease, affecting millions of people in the United States alone. The incidence of Nonalcoholic Fatty Liver Disease (NAFLD) is very similar to that of obesity, type-2 diabetes, and the metabolic syndrome, suggesting a…
This study is evaluating how well odevixibat, an approved medication for Alagille Syndrome (ALGS), works in real-world clinical practice and how safe it is for long-term use. Participants with ALGS who are receiving odevixibat as part of their usual medical care will be followed for about five years. During this time, information from routine clinic visits…
The purpose of this study is to evaluate the study drug, pemvidutide, as a possible treatment for alcohol associated liver disease or ALD. ALD is a condition in which excessive alcohol use (commonly defined as more than 2 drinks per day for women and 3 drinks per day for men) leads to liver inflammation and damage. Pemvidutide is investigational, meaning…
The purpose of this study is to determine if an experimental drug, INT-787, is safe and effective in patients who are hospitalized due to severe alcohol-associated hepatitis. This is a double-blind study, so the study doctors and participants will not know if they are receiving INT-787 or a placebo. Participation will last approximately 3 months. If you…
This Phase III trial investigates if the incorporation of immunotherapy will improve progression-free survival (PFS) and maintain overall survival (OS) while simultaneously minimizing long-term morbidity and treatment-related mortality by reducing exposure to radiotherapy and high cumulative chemotherapy doses. The study will enroll patients ages 5 to 60…
TReatment for ImmUne Mediated PathopHysiology (TRIUMPH) is a multi-center, three-arm clinical trial of immunosuppressive therapy for children with acute liver failure. This is a double-blind study, so the study doctors and participants will not know to which arm the participants are assigned. The study will determine if corticosteroids or equine anti-…
The purpose of this study is to determine whether the investigational drug (maralixibat) is safe and effective in children and participants who have cholestatic liver disease with pruritus (itch) that has been responding to other therapies, and who have no other treatment options.If you have any questions regarding this study, please contact the Transplant…
The purpose of this study is to learn whether wearable technology and the biometric data (e.g. heart rate, activity level, sleep) collected from it can be useful to detect clinical changes in those with liver disease, so that in the future it may help to prevent complications. The wearable technology that will be utilized in this study is the Oura Ring.…
The purpose of this study is to better understand how common and how severe pruritis (itching) is in children and adults under 21 years of age with Primary Sclerosing Cholangitis (PSC). The study involves the completion of two short online surveys. If you have any questions regarding this study, please contact the Transplant Clinical Research Center (TCRC).
TARGET-Liver Disease (TARGET-LD) is an observational research study to learn more about adult patients who have been diagnosed with a chronic liver disease (CLD). This includes collecting information about their health and the medications they take to manage their disease. Participation in this study will be approximately 15 years. If you have any questions…
The purpose of this clinical research study is to learn more about the use of the investigational study drug, volixibat, for the treatment of pruritus (itching) associated with primary sclerosing cholangitis or PSC. Volixibat is a drug that is designed to lower circulating bile acid levels may lead to the itching in patients with PSC. Eligible patients will…
The purpose of this research study is to determine if an investigational drug, VS-01, will help in the treatment of acute-on-chronic liver failure (ACLF) compared to supportive care (standard of therapy). ACLF is a potentially life-threatening condition characterized by a group of signs that occur together (syndrome) in patients with a late stage of…
The purpose of this research study is to determine if an investigational drug, VS-01, will help in the treatment of acute-on-chronic liver failure (ACLF) compared to supportive care (standard of therapy). ACLF is a potentially life-threatening condition characterized by a group of signs that occur together (syndrome) in patients with a late stage of…
The purpose of this study is to find out if a new laboratory blood test for patients with Wilson's disease can accurately and reliably measure so-called free copper, also known as non-ceruloplasmin copper (NCC). Participation will last about 12 months. If you have any questions regarding this study, please contact the Transplant Clinical Research…
The purpose of this study is to determine if an experimental drug, ALN-HSD, is safe and effective in patients diagnosed with non-alcoholic steatohepatitis (NASH), or metabolic dysfunction associated steatohepatitis (MASH) by improving liver function and lessening liver inflammation. This is a double-blind study, so the study doctors and participants will…
LCN Cohort Study is an observational study designed to identify risk factors and develop prediction models for risk of decompensation in adults with liver cirrhosis. LCN Cohort Study involves multiple institutions and an anticipated 1200 participants. Enrolled participants will have study visits every 6 months for a total of 3 years. Some of the visit…
The purpose of this study is to compare V940 plus pembro given after surgery to a placebo plus pembro given after surgery and to study how effective the study drug is. A placebo looks like a study drug, but it has no active ingredients. V940 has not yet been approved by the Food and Drug Administration (FDA). Pembrolizumab is FDA approved but it has not…
The purpose of this study is to see if Isatuximab can alter the immune system favorably in patients with multiple myeloma or lymphoma upon recovery from the autologous stem cell transplantation. This study will have two arms. On one arm (control arm), Participants will receive standard transplant procedures and on the other arm (experimental arm),…
Hepatorenal Syndrome-Acute Kidney Injury (HRS-AKI) is a type of kidney failure that progresses very quickly and is due to severe liver disease. Terlipressin is approved in the United States for treatment of HRS-AKI. This study will test the safety and effectiveness of terlipressin alone compared to a combination of an investigational (experimental) drug…
The purpose of this study is to see if IMC-F106C, in combination with nivolumab, works better than the standard therapy (nivolumab alone or in combination with relatlimab) at making tumors stop growing or shrink. IMC-F106C has not yet been approved by the Food and Drug Administration (FDA). Nivolumab and the combination of nivolumab + relatlimab is FDA…
The main purpose of this study is to collect information on patients undergoing a Transjugular Intrahepatic Portosystemic Shunt (TIPS) procedure. The goal of this study is to collect information about patients undergoing a TIPS and to evaluate the long-term outcomes and complications over a 5-year period. Subjects will be asked to complete four…
Epstein-Barr Virus (EBV) is the virus that causes mononucleosis, also known as mono. Almost all adults have had EBV. For most people, EBV never causes a health problem. However, when their immune system is not working properly (like people who have had a transplant and must be on medications that suppress their immune system), EBV can cause certain diseases…
The TARGET-HBV study engages an observational research design to conduct a comprehensive review of therapeutic outcomes for patients with chronic hepatitis B (HBV) who are currently taking tenofovir alafenamide (TAF) relative to those patients following other treatment regimens. The study will address important clinical questions regarding the management of…
This study evaluates whether odevixibat is safe and effective compared to placebo in children with biliary atresia who have recently undergone a Kasai procedure. This is a double-blind study, so the study doctors and the child/parent will not know whether the child is receiving odevixibat or placebo. Participation will involve several research visits over…
The main purpose of this study is to determine how safe and effective fazirsiran is in patients with alpha-1 antitrypsin deficiency-associated liver disease (AATD-LD) compared to placebo. Eligible participants will receive either fazirsiran or placebo for about 4 years. This is a double-blind study, so the study doctors and participants will not know…
This study is being done to determine if a study drug called lenalidomide can be combined with full doses of EPOCH chemotherapy for patients with Adult T-Cell Leukemia-Lymphoma (ATLL), and to define the highest dose and longest duration of lenalidomide that can be given safely in combination with EPOCH. EPOCH chemotherapy is a combination of five…
This is a 20-year study of adult patients with Primary Sclerosing Cholangitis (PSC). The purpose of this research study is to evaluate PSC throughout North America, as PSC is a rare disease, and not enough information is available for patients, clinicians, and researchers to help guide medical decisions and to help find new treatment options. Participants…
The purpose of this study is to determine the safety and efficacy of CMP-001 when given in combination with nivolumab for patients with unresectable (not capable of being surgically removed) or metastatic (cancer spreads to a different body part from where it started) melanoma. CMP-001 will be given as an injection into the tumor and nivolumab will be given…
This research study is being done to test the effectiveness and safety of an investigational treatment called LOXO-305. LOXO-305 is an investigational (or experimental) drug that may treat certain cancers like leukemia and lymphomas, including, mantle cell lymphoma (MCL). These cancers are dependent on or addicted to a protein made by the cancers called BTK…
The purpose of this research study is to obtain information on the safety and effectiveness of PBCAR19B to treat certain types of cancers. PBCAR19B is a new investigational treatment for certain types of cancer of the blood, such as leukemia and lymphoma. It is made from a type of blood cells known as T cells. The T cells in PBCAR19B came from healthy…
The purpose of this research study is to test the safety and efficacy of AU-011 at different doses and different number of doses of study drug when it is injected into the suprachoroidal space of the eye with one or two laser light applications and to find out what effects, if any, it has on research participants with a choroidal melanoma tumor or…
This study consists of two treatment groups, Part 1 and Part 2. The purpose of this study is to: Part 1 - Test the safety and tolerability of the study drug IN10018, see how well the drug works on your metastatic uveal melanoma, and see how your body handles the drug. Part 2 - Test the safety and tolerability of the study drug IN10018 with cobimetinib, see…
The purpose of the study is to determine the long-term effectiveness and safety of cemiplimab in patients diagnosed with Cutaneous Squamous Cell Carcinoma (CSCC, a type of skin cancer).
The Red-C 3131 Study is a phase 3 study is looking to see if a study medicine, rifaximin, can safely delay or prevent HE in adults who have been diagnosed with advanced liver cirrhosis. Adults who have been diagnosed with advanced liver cirrhosis, but who don't yet have HE may be eligible to join. About 466 patients will be enrolled across 200 sites.…
The purpose of this study is to test the good and bad effects of the combined treatment, using the drugs cetuximab and avelumab as well as avelumab by itself. Avelumab is a drug that works by triggering the immune system so it can try to attack the cancer again. Avelumab works in a similar way to cemiplimab, which is the usual drug for treatment of your…
The purpose of the study is to evaluate the effectiveness (how well the drug works) of the investigational drug called bempegaldesleukin when combined with drug nivolumab in comparison with nivolumab alone after complete resection (removal of all sites of known disease) of melanoma in participants at high risk of cancer returning after surgery (recurrence).
This research study is a phase II clinical trial that will study the combination of adjuvant nivolumab and ipilimumab for the treatment of adult subjects with completely treated high-risk ocular melanoma. This study is being done to see if the combination of the study drugs is safe and effective in preventing the return of their cancer. If you are eligible…
This is a randomized, double-blinded, placebo-controlled phase 2 study. The purpose of this study is to evaluate the safety and efficacy of Saroglitazar magnesium 2 mg and 4mg versus placebo in the treatment of subjects with Primary Biliary Cholangitis. The research study consists of a Screening Phase (Visits 1 and 2) that lasts up to 42 days, a Treatment…
The purpose of this study is to better understand the use of Valchlor in clinical practice. Other goals include describing the demographic and clinical characteristics of disease and health outcomes of patients treated with Valchlor. Participating in this study will not influence the usual care you receive from your doctor.
The purpose of this research study is to test the safety of Light-activated AU-011 at three different doses of the study drug and repeat dose regimens (two or three doses of highest safe dose) to find out what effects, if any, it has on research participants with a choroidal melanoma tumor. This study will have a high dose, a medium dose, and a low dose of…
The main purpose of this research study is to determine if the experimental product, KTE-C19, when administered after a 3 day course of chemotherapy, is safe and effective in treating relapsed or refractory (r/r) indolent non-Hodgkin B-cell lymphoma (iNHL). KTE-C19 is made from white blood cells that are removed from the individual. A virus (retrovirus) is…
The primary objective of the study is to evaluate safety and effectiveness of ELAD with respect to overall survival of subjects with a clinical diagnosis of alcohol-induced liver decompensation (ALID). Subjects will be randomly assigned to receive either standard of care treatment for ALID plus treatment with the ELAD system or standard of care treatment…
The purpose of this study is to determine the effectiveness and safety of study drug MEDI4736 monotherapy, tremelimumab monotherapy, and MEDI4736 and tremelimumab combination therapy in the treatment of patients with recurrent or metastatic PD-L1-negative squamous cell carcinoma of the head and neck who have progressed during or after treatment with…
The purpose of this study is to evaluate the efficacy, safety, and tolerability of SOF/VEL/GS- 9857 FDC in patients infected with Hepatitis C (HCV), and previously treated unsuccessfully. Information about any side effects that may occur will also be collected.
This is the first study in humans for an investigational drug called CX-072. CX-072 is a Probody therapeutic directed against PD-L1 (programmed cell death ligand 1). Probody therapeutics are created from antibodies.
The purpose of this study is to test a drug called GSK2330672 that is not yet approved for doctors to prescribe for patients who have a condition called primary biliary cholangitis (PBC) which has caused moderate to severe pruritus, or itching, in parts or all of the body. The objective is to find out if the drug can help to decrease the itchiness that…
The purpose of this study is to see if study drug IMO-8400 is safe and effective in the treatment of patientswith relapsed or refractory Diffuse Large B-Cell Lymphoma following conventional treatment.Examples of conventional treatment are radiotherapy, immunotherapy, chemotherapy, orradioimmunotherapy. Patients are scheduled to participate in this study…
The purpose of this study is to compare the efficacy and safety of cobimetinib plus atezolizumab with the efficacy and safety of pembrolizumab in patients with a type of skin cancer called melanoma that has spread to other parts of the body (metastatic), cannot be removed by surgery (unresectable), and have not received any prior treatment.
The purpose of the Main study is to test the overall effects of E7777 on you and your illness. It is not known what effect E7777 will have on your illness or what the side effects will be. This study will look at the effect E7777 has on your body and your disease. It will also look at how your body absorbs, distributes, breaks down, and gets rid of the…
NASH is a liver disease associated with inflammation and liver cell injury visible under a microscope with a liver biopsy. This condition may lead to advanced fibrosis and cirrhosis and deserves serious medical management. Once cirrhosis has developed, the serious complications of liver disease may occur, including liver failure. NASH might also lead to…
The purpose of this study is to compare the time to onset of an episode of overt HE, in subjects with previously demonstrated overt HE after treatment with rifaximin 550 mg BID and lactulose, or rifaximin 550 mg BID. Subjects will be screened to confirm eligibility into the study. Once confirmed, subjects will begin the treatment phase and will be randomly…
The purpose of this study is to gather information on the safety of TH-302 and its effect on your cancer. This study will also look at how the drug is processed in the body. In addition, this study will collect data from blood, tumor, and imaging studies about your specific cancer such as the level of oxygen that is present. This may help us understand…
The purpose of this research study is to determine if high-dose versus standard-dose regimens of encorafenib and binimetinib are safe and have positive effects in people who have melanoma brain metastasis and also have been found by their doctor to have a mutated gene called BRAFV600. The time frame for the study is approximately 2 years.
The purpose of this study is to find out how doctors describe hepatic encephalopathy episodes in patients medical records in the course of their regular practice. The aim of the study is simply to collect information from their medical records about how their episodes of overt hepatic encephalopathy are described. There is nothing that will be required of…
The purpose of this study is to find out more about the Amgen agent called talimogene laherparepvec in people with advanced melanoma when given in combination with another drug developed by Merck called pembrolizumab. Melanoma is a type of skin cancer. Advanced melanoma means the tumor is not removable by surgery or has spread to other parts of the body.
Patients who have been diagnosed with decompensated nonalcoholic steatohepatitis (NASH) cirrhosis may be eligible to participate in this clinical trial. NASH is liver inflammation and damage caused by a buildup of fat in the liver. The main purpose of the study is to test the safety and efficacy of a drug called Emricasan (IDN-6556) in reducing the risk…
The purpose of this study is to determine a safe dose by testingthe investigational product, AGS67E at different dose levels. Secondly, to test what effects, good and/or bad, it has on subjects with refractory or relapsed non-Hodgkin lymphoma (NHL), chronic lymphocytic leukemia (CLL), prolymphocytic leukemia (PLL) or hairy cell leukemia (HCL). We will also…
This study is for patients with non-alcoholic steatohepatitis (NASH) fibrosis in which there is too much fat in the liver causing inflammation and fibrosis. This condition is similar to the type of liver damage that occurs from too much alcohol use, but is not primarily caused by alcohol use. The main purpose of the study is to test whether a drug called…
The Sponsor is conducting this study to find out how safe and effective the investigational drug (alsocalled a study drug) obeticholic acid (also known as OCA) may be in improving compensated cirrhosis caused by NASH. Currently, there are no therapies approved for the treatment of NASH. OCA (the brand name is Ocaliva) has been approved in several…
The purpose of this study is to evaluate the efficacy of the drug OCR-002 for the treatment of an acute hepatic encephalopathy episode in cirrhotic patients requiring hospitalization. Subjects who have been recently hospitalized will potentially receive OCR-002 via infusion on top of their standard care for 5 days. Patients will be assessed 24-hours after…
The purpose of this study is to examine the effects of KPT-330 on patients with an advanced form of skin cancer called Squamous Cell Cancer (SCC) of the head and neck, lung, or esophagus. The study drug KPT-330 is an investigational drug that
The purpose of this study is to find out if the experimental combination of lenzilumab (an antibody that blocks the cytokine GM-CSF) and axicabtagene ciloleucel (which is identical to the FDA-approved CAR-T cell product YESCARTA) helps in protecting patients from side effects of axicabtagene ciloleucel. While axicabtagene ciloleucel has been approved by the…
The main purpose of this research study is to investigate the effectiveness of avatrombopag (the study drug under investigation) in increasing the amount of platelets (a type of cell found in the blood) in patients with chronic liver disease who need to have an elective procedure but have thrombocytopenia (low platelet counts) related to the chronic liver…
This is a phase II research study for individuals with resectable, stage IIIB to IVM1a Melanoma. The research drug being studied is talimogene laherparepvec. Talimogene laherparepvec is still experimental and has not been approved by the Food and Drug Administration (FDA) for use in people with melanoma. The purpose of this study is to find out more about…
This research trial is being conducted to determine the safety and efficacy of HARVONI (an FDA-approved Hepatitis C Virus medication) in HCV (genotype 1, 4, 5, an 6) infected patients who also have advanced heart failure or chronic lung disease. HARVONI has not been tested in patients with HCV and heart failure or chronic lunch disease. Subjects will take…
The purpose of this study is to gather information about the effectiveness and safety of as drug called brentuximab vedotin when given in combination with another drug called bendamustine for Hodgkin Lymphoma. The study will assess the safety profile of the combination treatment and determine what proportion of patients achieve a complete remission.…
This study will compare two experimental drugs, named Sofosbuvir/Velpatasvir/GS-9857 Fixed-Dose Combination (SOF/VEL/GS-9857 FDC) and Sofosbuvir/Velpatasvir (SOF/VEL FDC) for 12 weeks for the treatment of chronic hepatitis C virus (HCV) infection in subjects who have previously been unsuccessfully treated for chronic HCV.. An experimental drug is one that…
Epstein-Barr Virus (EBV) is the virus that causes mononucleosis, also known as mono. Almost all adults have had EBV. For most people, EBV never causes a health problem. However, when their immune system is not working properly (people who have had a transplant and those who have immune disorders), EBV can cause certain diseases where cells grow abnormally…
This study is a multicenter study to assess the efficacy, safety, and tolerability of vk2809 administered for12 weeks followed by a 4-week off-drug Phase in subjects with primary hypercholesterolemia and nonalcoholic Fatty liver disease. This study will investigate the efficacy, safety, and tolerability of VK2809 in lowering LDL-C and liver fat content in…
The purpose of this study is to see if study drug Sofosbuvir/Ledipasvir fixed-dose combination + Ribavirin (SOF/LDV FDC + RBV) are effective in treating people infected with the hepatitis C virus with genotypes 1 and 4, who have advanced liver disease with permanent liver damage (cirrhosis) and may be showing signs of liver failure or who have undergone…
The purpose of this study is to find out if the drugs LEE011 and MEK162, administered in combination, are safe and effective in treating people who have melanoma. Specifically, this study will evaluate the effects of the combination of the two drugs, LEE011 and MEK162, in melanoma, carrying specific mutation in a gene called NRAS. The changes in the NRAS…
The purpose of this study is to test the effectiveness (how well the drug works), safety, and tolerability of an investigational drug called nivolumab (also known as BMS-936558). This study will see if treatment with nivolumab increases the chance you will have a positive response (complete or partial) in treating your primary central nervous system…
The purpose of the first part (Phase I) of the study is to test the safety of navitoclax in combination with dabrafenib and trametinibat different doses to find out what effects, if any, it has on people. There will be about 18 people treated in this part of the study. The purpose of the second part of this study (Phase II) is to compare the good and bad…
The purpose of this study is to find out if the experimental product, axicabtagene ciloleucel, in combination with either rituximab or lenalidomide is safe and effective in treating lymphoma. Kite Pharma, Inc., (Kite) is the sponsor of this study. The sponsor is funding this research study and has also designed the trial. The sponsor is testing an…
NOTE: YOU MUST HAVE HIV AND HAVE EVER HAD HEPATITIS C TO BE ELIGIBLE FOR THIS STUDY!! ............... For individuals who have both HIV and Hepatitis C virus (HCV), heavy drinking poses serious risks to their health. We do not yet know which interventions are effective at helping individuals with HIV and HCV drink less. The goal of the study is to compare…
The purpose of this study is to learn more about the effects of the combination of telaprevir peginterferon alfa2b (Peg-IFN) and ribavirin (RBV) in children with chronic hepatitis C. Investigators will look at how these study drugs may affect childrens bodies and how children break down and eliminate telaprevir. Participants of this study will receive Peg-…
This study is for adult subjects with head and neck cancer (oral cavity, oropharynx middle part of the throat, hypopharynx bottom part of the throat, or larynx part of throat between the base of the tongue and the windpipe) that has either returned after treatment (recurrent) or is newly diagnosed. If newly diagnosed, the cancer must be metastatic,…
This study is for patients with Nonalcoholic Steatohepatitis (NASH) and also suffer from obesity and Type 2 diabetes Mellitus type II or prediabetes. The purpose of this study is to determine the effect of Aramchol on liver inflammation, in addition to fat reduction in the liver. NASH (Nonalcoholic Steatohepatitis) is a common, often silent liver disease.…
This is a phase 2 study to determine the efficacy and safety of Naloxone HCL Lotion 0.5% for the treatment of mycosis fungoides (MF) type of cutaneous T-cell lymphoma (CTCL). Selected subjects will have the study drug applied to determine its effect on reducing itchiness and any potential side effects. Naloxone has previously been approved for direct blood…
This study will compare the effectiveness of three different FDA approved medicines for Hepatitis C Genotype 1 patients: HARVONI , Viekira Pak and Zepatier and will observe subject experiences before, during, and after HCV treatment. Subjects will be asked to respond to several survey questionnaires and if they would allow their leftover blood collected for…
The purpose of this study is to determine the safety and effects of a drug, sorafenib in adults diagnosed with hepatopulmonary syndrome (HPS). The study will evaluate how well the drug is tolerated and its effect on the level of oxygen in the blood and the function of the lung vessels. Participants will be randomly assigned to receive either sorafenib or a…
The purpose of this study is to find out more about talimogene laherparepvec (formerly known as OncoVEXGM-CSF), in people with advanced melanoma when given in combination with another drug called ipilimumab. Melanoma is a type of skin cancer. Advanced melanoma means the tumor is not removable by surgery or has spread to other parts of the body. Phase 1 of…
This is a research study to test the effectiveness of NM-IL-12 an experimental drug, in combination with low dose Total Skin Electron Beam Therapy (TSEBT) for treatment of Cutaneous T Cell Lymphoma. The study will enroll 10 subjects age 18 years and older.Treatment will consist of 3 weeks of TSEBT, and up to 27 weeks of NM-IL-12 treatment starting from day…
The purpose of this study is to determine how effective and safe the immune drug Nivolumab is for patients who have newly diagnosed cutaneous melanoma. Nivolumab is an anti-body, a type of human protein, that is being tested to see if it will allow the body's immune system to work against tumor cells. If you are eligible for the study, you will…
This is a 2-part, multicenter study of a study drug in pediatric and young adult patients with mature B-cell non-Hodgkin Lymphoma which has come back or has not responded to the standard therapy. The study treatment is considered an experimental because the study drug is not approved by the United States (US) Food and Drug Administration (FDA) for treating…
The purpose of this study is to evaluate whether cirrhosis occurs as a result of NASH. NASH is a disease that results when fat accumulates in the liver. GS-6624 is an experimental medication designed to help reverse the scarring process, and the purpose of this study is to see if GS-6624 can reverse the scarring in the liver and heal cirrhosis.
This study is for patients with melanoma, non-small cell lung cancer (NSCLC), or squamous cell cancer of the head and neck (SCCHN) that has a protein called B7-H3 on the tumor cells or blood vessels in thetumor. The purpose of this study is to test the safety, tolerability, and most effective dose ofMGA271 in combination with ipilimumab (also called Yervoy…
This study will compare two experimental drugs, named Sofosbuvir/Velpatasvir/GS-9857 Fixed-Dose Combination (SOF/VEL/GS-9857 FDC) and Sofosbuvir/Velpatasvir (SOF/VEL) FDC for the treatment ofchronic genotype 3 hepatitis C virus (HCV) infection in patients who have cirrhosis, or scarring of the liver. The purpose of this study is to determine the efficacy,…
This is a phase 3 clinical trial to determine the efficacy of topical SGX301 (synthetic hypericin) in combination with visible light therapy on cutaneous T-cell lymphoma (CTCL). Selected subjects can participate in 3 cycles each consisting of a 6 week treatment period where a chosen lesion will be treated with the study ointment (twice a week) followed by…
This is a 5-year, longitudinal, observational study of patients with NAFL or NASH designed to specifically address important clinical questions that remain incompletely answered from registration trials. The main purpose of this research study is to collect and study information on patients with NAFLD/NASH.The goal of this study is to observe any treatment…
This study will test the standard R-CHOP21 against R-CHOP21 plus lenalidomide. The purpose is to see whether adding lenalidomide works better and is as safe as R-CHOP by itself. This study is only for patients with ABC type DLBCL who have not yet been treated. Lenalidomide is not approved for use in DLBCL. Its use in this disease is experimental. In this…
The purpose of this study is to find out which participants with melanoma respond best to nivolumab and ipilimumab treatment and to identify tumor and blood based markers that may predict response to the combination. This study is asking that participants submit tumor tissue samples from their initial tumor specimen and blood samples before they receive…
The main purpose of this research study is to determine if the experimental treatment, axicabtagene ciloleucel in combination with utomilumab, is safe and effective in treating individuals with Large B-cell Lymphoma. Axicabtagene ciloleucel is manufactured using your own blood cells. Utomilumab is a molecule (protein) which interacts with a specific region…
If you have primary biliary cholangitis (PBC), previously referred to as primary biliary cirrhosis, you may qualify for a clinical research study. In this study, doctors are trying to learn more about the effectiveness and safety of an investigational drug called seladelpar for patients with PBC. The ENHANCE clinical research study is enrolling patients who…
The purpose of this study is to determine how safe and effective using three medications (pegylated-interferon, ribavirin and boceprevir) are in curing HCV in patients with end stage kidney disease on hemodialysis. Participants will be prescribed these three medications and will be followed closely through treatment, then for 6 months afterwards. During…
This study is for patients with recurrent or metastatic Squamous Cell Carcinoma of the Head and Neck (SCCHN). This study will test the safety of an experimental anti-cancer drug (MEDI4736). MEDI4736 is an antibody (a protein produced by the defense system of the body immune system) that has been made in the laboratory. MEDI4736 boosts the ability of your…
The purpose of this study is to evaluate the effectiveness, safety, and tolerability of study drugs Sofosbuvir, Velpatasvir and GS-9857 in comparison to Sofosbuvir and Velpatasvir in patients infected with HCV. Information about any side effects that may occur will also be collected.
You are being asked to participate in a research study because you have Cutaneous T-Cell Lymphoma/Mycosis Fungoides, and one of your symptoms is itching. This study is being done to assess the efficacy and safety of Naloxone HCL Lotion 0.5% compared to Vehicle Lotion for the treatment of itching in patients with mycosis fungoides (MF) which is a type of…