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…
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…
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-…
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 (…
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 (…
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…
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…
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…
In this research, we want to learn more about how to improve care for children who are listed for or who have received a liver transplant. The goal of this research is to look at how different hospitals treat these children and to look at their outcomes to help improve care, decrease complications, shorten length of hospital stay, reduce hospital re-…
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 Center (…
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…
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 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…
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…
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…