A 12-month, open-label, multicenter, randomized, safety, efficacy, pharmacokinetic (PK) and pharmacodynamic (PD) study of two regimens of anti-CD40 monoclonal antibody, CFZ533 vs. standard of care control, in adult de novo liver transplant recipients with a 12-month additional follow-up (CONTRAIL I) Save

Date Added
February 25th, 2020
PRO Number
Pro00089195
Researcher
Derek Dubay

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Keywords
Liver, Transplant
Summary

This study is testing an investigational (not yet FDA approved) drug called CFZ533 compared to standard of care anti-rejection medications in patients who are having a Liver transplant. This study drug is being tested because it may have fewer long-term side effects than current standard therapy. This study is for first time liver transplant patients. Study drug will be administered every 2 weeks and participation will last for 2 years after transplant surgery.

Institution
MUSC
Recruitment Contact
Tamara Jenkins
843-792-1851
saundert@musc.edu

A Phase 2, Randomized, Double-blind, Placebo-controlled Study of the Efficacy and Safety of VX-814 in PiZZ Subjects Save

Date Added
February 25th, 2020
PRO Number
Pro00096021
Researcher
Charlie Strange

List of Studies


Profiles_link
Keywords
Liver, Lung, Pulmonary
Summary

Alpha-1 Antitrypsin (AAT) is a naturally occurring protein involved in the protection of lungs from inflammation. A mutation in the AAT gene (a change in the body's genetic instructions on how to make AAT) causes it to be made incorrectly and very little of it gets into the bloodstream. Severe AAT deficiency (lack of AAT in the blood) causes emphysema, which causes holes in the lungs. This study is being done to learn more about the safety, tolerability and effectiveness of VX-814 in patients with Alpha-1 Antitrypsin Deficiency. There are 3 parts to this study: Parts A1, A2, and B. Participants can only join one part of the study. Participants in all groups will be randomly assigned to the treatment drug or a placebo (sugar pill). Participants in part A1 will have an 80% chance of receiving the treatment drug and participants in Part A2 and Part B will have a 75% chance of receiving the treatment drug.

Institution
MUSC
Recruitment Contact
Rachel Millan
843-792-0260
millanr@musc.edu

A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Safety, Tolerability, and Efficacy of GS-9674 in Non-Cirrhotic Subjects with Primary Sclerosing Cholangitis Save

Date Added
June 25th, 2019
PRO Number
Pro00087383
Researcher
Don Rockey

List of Studies


Profiles_link
Keywords
Liver
Summary

This is a Phase 3, randomized, double-blind, placebo-controlled study
evaluating the safety and efficacy of GS-9674 in subjects with PSC
without cirrhosis.

The study will consist of an 8-week Screening period,96 weeks of treatment, and a follow-up visit 4 weeks after completion of treatment. (Patients would be required to come to MUSC for 12 visits for a physical check-up, blood work, and to receive more study medication).

If the subject qualifies they will be randomized into one of two groups. The two groups include one receiving 100mg active GS-9674 or placebo. There is a 2/3 chance to be receiving active drug over placebo. The drug GS-9674 is a capsule that is taken once a day in the morning (with or without food).

The purpose of this study is to see if GS-9674 slows the scarring process in subjects with PSC.

Institution
MUSC
Recruitment Contact
Brittiny Bowers
843-876-8439
liverstudies@musc.edu

The effect of conversion to once-daily Envarsus on the neurologic toxicity burden in liver transplant recipients Save

Date Added
April 9th, 2019
PRO Number
Pro00083855
Researcher
Derek Dubay

List of Studies

Silhouette
Keywords
Liver, Transplant
Summary

The aim of this study is to determine if a long-acting tacrolimus product can reduce the severity and incidence of several neurotoxicities commonly seen after liver transplant. The medications being used in this study are extended release tacrolimus (Envarsus) and immediate release tacrolimus (Prograf). Participants will receive SOC treatment for up to 15 days and no longer than 12 months post-transplant, and then randomized to either Envarsus or Prograf for the 6 month duration of the study. There are 9 study visits that will involve tests, exams and procedures that are both standard of care and study purposes.

Institution
MUSC
Recruitment Contact
Courtney Rowley
843-792-7082
rowle@musc.edu

A Humanitarian Device Exemption Treatment Protocol of TheraSphere® For Treatment of Unresectable Primary or Secondary Liver Cancer Save

Date Added
November 6th, 2018
PRO Number
Pro00081570
Researcher
Ricardo Yamada

List of Studies

Silhouette
Keywords
Cancer/Gastrointestinal, Liver
Summary

TheraSphere® is a humanitarian use device (HUD) for treating cancer that originates in the liver. TheraSphere® consists of millions of tiny glass beads containing radioactive yttrium-90. The glass radioactive beads (20-30 micrometers in diameter ? about a third of the width of a human hair) are delivered directly to the liver tumors. It can be used to downstage tumors to become eligible for surgery or transplantation. It is also the only medical device approved in the United States to treat primary liver cancer patients with portal vein thrombosis (PVT). TheraSphere® has been approved as an HUD based upon its safety and probable benefit.

Institution
MUSC
Recruitment Contact
Susan Norton
843 814 8874
nortons@musc.edu

A Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging, Multicenter Study to Assess the Efficacy and Safety of Rifaximin Soluble Solid Dispersion (SSD) Tablets Plus Lactulose for the Treatment of Overt Hepatic Encephalopathy (OHE) Save

Date Added
August 14th, 2018
PRO Number
Pro00079199
Researcher
Don Rockey

List of Studies


Profiles_link
Keywords
Liver
Summary

The purpose of this study is to see if Rifaximin Soluble Solid Dispersion (SSD) Tablets are safe, well-tolerated, and whether they can better treat overt hepatic encephalopathy, a complication associated with liver cirrhosis, when compared to a placebo (an inactive substance).

Institution
MUSC
Recruitment Contact
Roula Sasso
843-792-0650
liverstuides@musc.edu

The reversibility of liver fibrosis after HCV eradication Save

Date Added
March 15th, 2018
PRO Number
Pro00076212
Researcher
Don Rockey

List of Studies


Profiles_link
Keywords
Liver
Summary

This an observational study that aims to assess the outcome of patients with advanced fibrosis and cirrhosis recurrence in patients with hepatitis C virus (HCV) infection after HCV eradication. We aim to describe this unique group of patients as well as determine whether any particular variables are significant predictors of fibrosis/cirrhosis resolution. A multivariate analysis will be conducted to determine risk factors independently related to fibrosis/cirrhosis resolution and clinical outcome.

Institution
MUSC
Recruitment Contact
Shaurya Prakash
843-860-8059
prakash@musc.edu

VAMC Non-Alcoholic Fatty Liver Disease (NAFLD) Research Database Save

Date Added
December 27th, 2017
PRO Number
Pro00056211
Researcher
Wing-kin Syn

List of Studies

Keywords
Diabetes, Digestive System, Liver, Obesity
Summary

Non-Alcoholic fatty liver disease is the most common liver disease, and involves fat deposition in the liver. The fat in the liver can lead to inflammation, scarring, end stage liver disease and potential liver cancer. Some patients with fat in their liver do not see these changes, and our current understanding of why some people are not affected while others see progression of their disease is poor. We are currently in process of initiating studies to learn more about fatty liver disease, and having a database of patients at the VA medical center who are willing to participate in these studies and future studies would help both the patients learn about the new and upcoming therapies, and help the clinical investigators to quickly screen their patients and invite them to participate in their studies.

Institution
MUSC
Recruitment Contact
Margaret Morrison
843-408-6080
morrmarg@musc.edu

A 5-year Longitudinal Observational Study of the Natural History and Management of Patients with Hepatocellular Carcinoma Save

Date Added
February 28th, 2017
PRO Number
Pro00062918
Researcher
David Koch

List of Studies


Profiles_link
Keywords
Cancer, Cancer/Gastrointestinal, Cancer/Other, Digestive System, Genetics, Liver, Obesity, Weight Control
Summary

TARGET-HCC is a 5-year, longitudinal, observational study of the natural history and management of patients with HCC. The study will address important clinical questions that remain unanswered in the management of HCC with a unique research registry of participants with HCC from academic and community real-world practices. TARGET-HCC is disease focused, not drug specific, which allows for continuous acquisition of real-world evidence regarding the natural history, management, and outcomes of treatment with current therapies and new treatments that may be utilized in usual clinical practice.

Institution
MUSC
Recruitment Contact
Francis Beylotte
843-876-4273
beylott@musc.edu

A 5-year Longitudinal Observational Study of Patients with Nonalcoholic Fatty Liver (NAFL) or Nonalcoholic Steatohepatitis (NASH) Save

Date Added
February 28th, 2017
PRO Number
Pro00062843
Researcher
David Koch

List of Studies


Profiles_link
Keywords
Disease Prevention, Genetics, Liver, Obesity, Weight Control
Summary

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. In addition to the study database, a bio specimen repository will also be included so that translational studies of genomics and biomarkers of response may be performed.

Institution
MUSC
Recruitment Contact
Francis Beylotte
843-876-4273
beylott@musc.edu

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