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  • Currently Recruiting (23)
  • Closed (15)

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  • Show all (54)
  • Cancer (3)
  • COVID-19 (Coronavirus) (1)
  • Infectious Disease (2)
  • (-) Liver Disease (18)
    • Cirrhosis of the Liver (2)
    • Hepatitis (1)
    • Liver Failure (2)
  • Pediatrics (5)
  • Transplant (25)
    • (-) Liver Transplant (20)
    • Stem Cell Transplant (2)
Displaying 1 - 38 of 38

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…
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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…
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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…
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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 (…
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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…
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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…
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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…
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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…
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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…
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Efficacy, Safety and Tolerability of VS-01 in Adult Patients With Acute-on-Chronic Liver Failure and Ascites (UNVEIL-IT)

Condition: Liver Disease / Liver Failure
Investigator: Elizabeth Verna, MD
Status: Currently Recruiting
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…
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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…
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Efficacy, Safety and Tolerability of VS-01 in Adult Patients With Acute-on-Chronic Liver Failure and Ascites (UNVEIL-IT)

Condition: Liver Disease
Investigator: Elizabeth Verna, MD
Status: Currently Recruiting
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…
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Using Gene Silencing to Treat Chronic Liver Disease Non-Alcoholic Steatohepatitis (NASH) in Adults at Increased Genetic Risk (NASHGEN-2)

Condition: Liver Disease
Investigator: Julia Wattacheril, MD, MPH
Status: Currently Recruiting
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…
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Liver Cirrhosis Network (LCN) Cohort Study

Condition: Liver Disease / Cirrhosis of the Liver
Investigator: Elizabeth Verna, MD
Status: Currently Recruiting
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…
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Biometrics in Liver Disease

Condition: Liver Disease
Investigator: Avesh Thuluvath, MD
Status: Currently Recruiting
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…
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An Observational Study of Patients with Chronic Liver Disease

Condition: Liver Disease
Investigator: Elizabeth Verna, MD
Status: Currently Recruiting
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…
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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…
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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…
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Omics Prospective Tissue Collection

Condition: Liver Disease
Investigator: Julia Wattacheril, MD, MPH
Status: Currently Recruiting
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…
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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…
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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…
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TReatment for ImmUne Mediated PathopHysiology (TRIUMPH)

Condition: Liver Disease / Liver Failure
Investigator: Steven Lobritto, MD
Status: Currently Recruiting
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…
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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…
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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 (…
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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…
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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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Maralixibat for Treatment of Cholestatic Pruritus (MRX-802 EXPAND)

Condition: Liver Disease
Investigator: Mercedes Martinez, MD
Status: Currently Recruiting
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…
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Study to Evaluate R2R01 Plus Terlipressin Versus Terlipressin Alone in Patients With Hepatorenal Syndrome

Condition: Liver Disease
Investigator: Giuseppe Cullaro, MD
Status: Currently Recruiting
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…
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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…
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FXR Effect on Severe Alcohol-Associated Hepatitis (FRESH)

Condition: Liver Disease
Investigator: Elizabeth Verna, MD
Status: Currently Recruiting
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…
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Assessment of Pruritis (Itch) in Children with Primary Sclerosing Cholangitis

Condition: Liver Disease
Investigator: Mercedes Martinez, MD
Status: Currently Recruiting
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…
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Real World Evidence Study in Subjects With Wilson's Disease

Condition: Liver Disease
Investigator: Steven Lobritto, MD
Status: Currently Recruiting
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…
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VISTAS - A Clinical Research Study for Primary Sclerosing Cholangitis (PSC)

Condition: Liver Disease
Investigator: Mercedes Martinez, MD
Status: Currently Recruiting
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…
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The Redwood Study for Alpha-1 Antitrypsin Deficiency Associated Liver Disease

Condition: Liver Disease
Investigator: Dana Goldner, MD
Status: Closed
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…
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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 for subjects with Chronic HCV with advanced liver disease using study drug combination (Sofosbuvir/Ledipasvir + Ribavirn)

Condition: Liver Disease / Hepatitis
Investigator: Robert Brown, MD, MPH
Status: Closed
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…
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Rosuvastatin Efficacy and Safety for Cirrhosis in the United States (RESCU)

Condition: Liver Disease / Cirrhosis of the Liver
Investigator: Elizabeth Verna, MD
Status: Closed
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…
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Study of Odevixibat in Children With Biliary Atresia Who Have Undergone a Kasai HPE (BOLD)

Condition: Liver Disease
Investigator: Dana Goldner, MD
Status: Closed
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…
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