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  • Kidney Disease (2)
  • (-) Liver Disease (18)
    • Cirrhosis of the Liver (2)
    • Hepatitis (1)
    • Liver Failure (2)
  • (-) Pediatrics (15)
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  • Transplant (51)
Displaying 1 - 33 of 33

Live-Viral Vaccination after Pediatric Liver Transplantation

Condition: Pediatrics
Investigator: Steven Lobritto, MD
Status: Currently Recruiting
In this study, we will collect information from the medical record of pediatric liver transplant recipients who received live vaccines as part of their routine post-transplant care. This data will be combined with data from other centers across the United States and Canada to help give us a…
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STARZL Network for Excellence in Pediatric Transplantation (SNEPT)

Condition: Pediatrics
Investigator: Steven Lobritto, MD
Status: Currently Recruiting
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…
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Studies of Pediatric Liver Transplantation (SPLIT)

Condition: Pediatrics
Investigator: Steven Lobritto, MD
Status: Closed
The purpose of the study is to collect scientific data on pediatric liver transplantation to learn more about how children do after liver transplant. Collecting these data is expected to help researchers learn more about liver transplant in children. This…
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Social and Contextual Impact on Children Undergoing Liver Transplant

Condition: Pediatrics
Investigator: Jennifer Vittorio, MD
Status: Closed
The social determinants of health have a large impact on health. We have previously demonstrated that an index of neighborhood socioeconomic deprivation was associated with an increased risk of medication non-adherence in children after liver transplant and an increased risk of graft failure and death in children after…
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Study of Hematopoietic Stem Cell Transplantation (HSCT) in non-cancer disease

Condition: Pediatrics
Investigator: Monica Bhatia, MD
Status: Closed
The overall purpose of this research is to treat diseases that are not cancer but are improved by bone marrow transplantation with mild and safer chemotherapy as pretransplant conditioning. This treatment is chosen because it is milder and is likely to have fewer long and short term side effects…
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Study of Olanzapine in Children Receiving Chemotherapy for Hematopoietic Stem Cell Transplant (HSCT)

Condition: Pediatrics / Cancer
Investigator: Diane George, MD
Status: Closed
This research study is to find out whether adding olanzapine to standard antiemetics will be helpful in controlling chemotherapy-induced vomiting (CINV) in children receiving high-dose cyclophosphamide for Blood/Bone Marrow Transplant (BMT) conditioning.
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Tacrolimus/Everolimus vs. Tacrolimus/MMF in Pediatric Heart Transplant Recipients Using the MATE Score (TEAMMATE) (Pediatric)

Condition: Pediatrics / Cardiology
Investigator: Irene Lytrivi, MD
Status: Closed
This is a Phase 3 multi-center open label randomized clinical trial. The purpose of this study is to learnmore about which anti-rejection (or immunosuppressive) medications best protect infants, children,adolescents, and young adults after they have had a heart transplant. Two different drug regimens will bewill be compared.…
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Study of Patients Receiving an Allogeneic Stem Cell Transplantation for Non-Malignant Disease

Condition: Pediatrics
Investigator: Diane George, MD
Status: Closed
The purpose of this study is to determine the incidence and severity of acute GVHD following CD34+ selection in children, adolescents and young adults receiving an allogeneic peripheral blood stem cell transplant from a family member or unrelated adult donor for a non-malignant condition.
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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 corticosteroids or equine anti-…
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TReatment for ImmUne Mediated PathopHysiology (TRIUMPH)

Condition: Pediatrics
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 corticosteroids or equine anti-…
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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 patients with a late stage of…
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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 patients with a late stage of…
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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, please contact the…
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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 very similar to that of obesity, type-2 diabetes, and the metabolic syndrome, suggesting a…
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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 investigational (experimental) drug…
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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 double-blind study, so the study doctors and participants will…
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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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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 this study is the Oura Ring.…
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Assessment of Pruritis (Itch) in Children with Primary Sclerosing Cholangitis

Condition: Pediatrics
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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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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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 study will be approximately 15 years. If you have any questions…
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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 years. Some of the visit…
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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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Study of EBV-CTLs in Patients with Epstein-Barr Virus-Associated Viremia or Lymphoma

Condition: Pediatrics / Cancer
Investigator: Ran Reshef, MD
Status: Closed
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…
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Natural History Study of Children with SCID (Severe Combined Immunodeficiency)

Condition: Pediatrics
Investigator: Olatundun Williams, MD
Status: Closed
This study is being done to identify the best outcomes for hematopoietic cell transplantation (HCT) or other treatment (enzyme replacement or gene therapy), which is life-saving therapy for children with SCID (severe combined immunodeficiency), leaky SCID, Omenn syndrome and reticular dysgenesis.
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Study of Odevixibat in Children With Biliary Atresia Who Have Undergone a Kasai HPE (BOLD)

Condition: Pediatrics
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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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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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 participants will not know…
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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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CD34 Stem Cell Selection for Malignant Condition

Condition: Pediatrics / Cancer
Investigator: Diane George, MD
Status: Closed
The purpose of this study is to determine the incidence and severity of acute GVHD following CD34+ selection in children, adolescents and young adults receiving an allogeneic peripheral blood stem cell transplant from a family member or unrelated adult donor for a malignant condition.
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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 may be showing signs of liver failure or who have undergone…
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Study of Combination Treatment to Reduce Occurrence and Severity of Chronic Graft Versus Host Disease (GVHD)

Condition: Pediatrics / Cancer
Investigator: Monica Bhatia, MD
Status: Closed
The purpose of this study is to compare two different combinations of treatment plans to a standard transplant procedure in order to see whether one or both of them are better at reducing the occurrence and severity of chronic GVHD. The research portion of this study involves manipulation of your stem cell product by removing…
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