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 purpose of the study is to compare how well Rina-S works against ovarian cancer, primary peritoneal cancer, or fallopian tube cancer compared to chemotherapy drugs that are already approved and used for your type of cancer. You have an equal (50:50) chance of getting Rina-S or an approved chemotherapy agent as treatment in this study. Rina-S is not…
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…
We are conducting a research study on how psoriasis might be caused or worsened by high levels of the blood sugar-lowering hormone insulin. We are seeking people with plaque psoriasis, ages 18-65, who are overweight or obese with a body mass index of 25-35. Participants will have blood drawn and small skin biopsies taken from psoriasis plaques and nearby…
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…
The purpose of this clinical research study is to develop a sample collection method that is less invasive than current endometrial sampling methods (uterine sample collection) and develop a diagnostic test from these samples which is as informative in diagnosing the absence of endometrial (uterine) cancer as currently available methods.
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 study is to examine the causes and pathology of alopecia areata and other hair and skin disorders. Skin biopsies and blood and/or clinical information collected in the study will be used for research aiming at developing new options for the treatment of alopecia areata and other skin and hair disorders.
Genetic studies help us to understand why some people develop certain diseases while others don't and also provide important clues about how best to treat the disease.
The goal of this clinical research study is to compare the outcomes of minimally invasive surgery (the investigational surgery) to laparotomy (the current standard of care) in women with Epithelial Ovarian Cancer (EOC) who receive chemotherapy before and after surgery. Researchers want to learn if one surgery can prevent the disease from returning for…
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 main purpose of this study is to learn about the safety of REGN4018 and to find out what dose of REGN4018 can be given alone or in combination with cemiplimab to research subjects with ovarian cancer without too many side effects. The study will also look at the levels of REGN4018 and/or cemiplimab in the body and measure how well your body can remove…
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 research study is to learn if sacituzumab govitecan (also called SG) can improve lifespan and delay the growth or spread of the disease in participants with endometrial cancer when compared to chemotherapy (doxorubicin or paclitaxel). Sacituzumab govitecan is a type of drug called an antibody-drug conjugate. An antibody-drug conjugate (…
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 research is to learn about what effects, both good and/or bad, an experimental drug called TransCon IL-2 / has when given by itself or in combination with pembrolizumab, SOC chemotherapy, or TransCon TLR7/8 Agonist, or in combination with pembrolizumab and SOC chemotherapy. TransCon IL-2 / works by blocking the reproduction and spread of…
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 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…
The main purpose of this study is to determine if two surgical procedures, the usual approach of removing the fallopian tubes and ovaries and the other approach of removing the fallopian tubes at this time with the plan to remove the ovaries at a later time, are no different for ovarian cancer risk reduction in women with BRCA1 mutations who have completed…
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…
Participants are being invited to take part in a clinical research study because they have been diagnosed with locally advanced or metastatic solid tumors with mutations in the following genes: MRE11, RAD50, NBN, or CCNE1 amplification. If the participant takes part in the study, they will take an investigational drug referred to as ZN-c3 (Study Drug).…
The purpose of this research study is to test the safety and determine the highest tolerable dose of SL-172154 (study drug) that can be given with Pegylated Liposomal Doxorubicin (PLD) or Mirvetuximab Soravtansine (MIRV). Another purpose of this study is to understand if SL-127154 and PLD or MIRV is effective in managing ovarian cancer. The study drug, SL-…
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…
XMT-1536 (upifitamab rilsodotin) is a targeted therapy, which means that it is directed specifically at a tumor. It is a type of antibody-drug conjugate; this means it has 2 parts that are joined together into one drug. The first part is an antibody that binds to NaPi2b (sodium-dependent phosphate transporter), a protein on the surface of the cells of your…
The purpose of this study is to assess whether an investigational drug, called XmAb20717, has any effects on your cancer, and to determine if it is safe and well tolerated. XmAb20717 is a type of drug that can attach to 2 different proteins, call a bispecific antibody. These antibodies are designed to attach to a T-cell, a type of immune system cell, in…
The purpose of this study is to find out of the combination of the drugs abemaciclib and letrozole is better or worse than usual approach for your type of cancer. The usual approach is defined as care most people get for endometrial cancer. People who are not in a study are usually treated with either surgery, radiation, hormonal therapy or with…
By doing this study, researchers hope to learn more about the efficacy (how well the drug works) and safety (the drugs side effects) of MORAb-202 (farletuzumab ecteribulin) compared to approved chemotherapy medications in patients with platinum-resistant ovarian cancer. The study will evaluate two doses of MORAb-202. MORAb-202, is made up of two parts; an…
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 determine whether SPL-108 injection might be useful for the treatment of ovarian cancer. The study will evaluate whether SPL-108 can slow the growth and spread of cancerous cells in your body. If you agree, you will be treated with SPL-108 injection in combination with paclitaxel and we will collect blood and tissue samples…
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 test the good and bad effects of olaparib in combination with temozolomide for the treatment of advanced uterine leiomyosarcoma (LMS). Olaparib and temozolomide could shrink your cancer, but could also cause side effects, which are described in the risks section below. The study doctors hope to learn if the study drug will…
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…
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 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 study is being done to determine if adding the investigational drugs (TSR-042 and niraparib) to standard of care treatment delays or prevents ovarian cancer recurrence (prevents the ovarian cancer from coming back).
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…
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…
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, which involves research, is being done to see how well an investigational new drug and study device combination will work to treat people with pre-cancerous cells on the cervix caused by human papillomavirus (HPV). The treatment combination is testing a drug, called VGX-3100, given by injection and used with the study device,…
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-…
The purpose of this study is to find out what effects, good or bad, cobimetinib and niraparib, given with or without atezolizumab, have on you and your cancer. In this study, you will receive either cobimetinib plus niraparib or cobimetinib plus niraparib plus atezolizumab. In addition, if you are assigned to receive cobimetinib and niraparib and your…
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.…
The main aim of this clinical trial is to know the effects (good or bad) that study drug lurbinectedin (PM01183), has on women with ovarian cancer. Lurbinectedin (PM01183), is an investigational drug. This means that the drug has not been approved by the Food and Drug Administration (FDA) for medical use in patients, but has only been approved for use in…
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…
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…
A Phase 2 Study of Atezolizumab (MPDL3280A) in Combination with Bevacizumab in Patients with Recurrent, Persistent or Metastatic Cervical Cancer. The purpose of this study is to test any good and bad effects of a combination of study drugs called atezolizumab and bevacizumab. The combination of atezolizumab and bevacizumab could shrink your cancer but it…
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.
Test the safety and effectiveness of the research study drug, pembrolizumab (MK-3475) in combination with chemotherapy, compared to chemotherapy plus placebo (a look-alike drug with no active ingredients) in women with persistent, recurrent, or metastatic cervical cancer. To test if adding pembrolizumab (MK-3475) to standard chemotherapy improves survival…
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 study will only include women who have platinum sensitive relapsed epithelial ovarian cancer meaning your ovarian cancer did not return for at least 6 months after your first treatment with chemotherapy containing platinum (carboplatin or cisplatin). This research is being done to find out if carboplatin plus paclitaxel or carboplatin plus Pegylated…
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…
The purpose of this study is to compare the effects of using Sodium Cridanimod in combination with the progestin (hormone therapy) megestrol acetate. Hormonal therapy on its own is generally not aneffective treatment for endometrial cancer when there are not have enough progestin receptors on tumor cells. The addition of the study drug Sodium Cridanimod…
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…
HE4 (Human Epididymis Protein 4) is a biomarker expressed in the normal lining of the female genital tract and breast. We are doing this research study to if HE4 is an indicator of treatment response during initial therapy for Primary Epithelial Ovarian, Fallopian Tube and Primary Peritoneal Cancers. For this we will collect blood at specific intervals.…
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.
This study is for women with one of the following cancers, cancer of the ovary, fallopian tube or peritoneum and you had previous treatment with carboplatin or cisplatin. The purpose of this research study is to find a different treatment for platinum-resistant TP53-mutated high-grade serous (HGS) ovarian cancer patients. The investigational drug AZD1775 is…
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 LIGHT study is a clinical research study for women who have been diagnosed with ovarian cancer. The purpose of the study is to evaluate the safety and effectiveness of an investigational drug in women with this type of cancer, using genetic information to evaluate tumors.
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 evaluate how accurately cells that are collected from the Fallopian tube can be categorized as benign or malignant. The MAKO 7 will be used to collect cell samples from the Fallopian tube. You are being asked to participate in the study because you are a woman who is undergoing a surgery to remove your Fallopian tubes and/or…
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.
The purpose of this study is to find out if the study drug, HE4 has the potential to improve performance of biomarker CA 125 to determine recurrence of epithelial ovarian cancer before detecting the cancer clinically, surgically or through radiological scans. HE4 (Human Epididymis Protein 4) is a biomarker expressed in the normal lining of the female…
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…
A single arm, open-label, Phase IIb study to assess the efficacy and safety of the combination of cediranib and olaparib tablets in women with recurrent platinum resistant epithelial ovarian cancer, including Fallopian tube and/or primary peritoneal cancer who do not carry a deleterious or suspected deleterious germline BRCA mutation. The purpose 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…