A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Safety and Efficacy of Selonsertib, GS-0976, GS-9674, and Combinations in Subjects with Bridging (F3) Fibrosis or Compensated Cirrhosis (F4) due to Nonalcoholic Steatohepatitis (NASH) Save

Date Added
April 10th, 2018
PRO Number
Pro00076641
Researcher
Don Rockey

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Keywords
Diabetes, Digestive System, Drug Studies, Exercise, Hypertension/ High Blood Pressure, Liver, Men's Health, Metabolism, Nutrition, Obesity
Summary

This is a Phase 2, randomized, double-blind, placebo-controlled study
evaluating the safety and efficacy of SEL, GS-0976, GS-9674, and
combinations in subjects with bridging fibrosis or compensated
cirrhosis due to NASH.
Subjects meeting the study's entry criteria will be randomly assigned in
a 2:2:1:1:1:1:2 ratio to 1 of 7 treatment groups, with approximately
70 subjects in each combination treatment group and approximately 35
subjects in each single agent or placebo group.

Institution
MUSC
Recruitment Contact
Megan Bickford
843-876-8439
liverstudies@musc.edu

The reversibility of liver fibrosis after HCV eradication Save

Date Added
March 15th, 2018
PRO Number
Pro00076212
Researcher
Melissa Youssef

Silhouette
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
Melissa Youssef
8648843508
youssefm@musc.edu

Key informant interviews to facilitate development of adherence tools in solid organ transplant Save

Date Added
March 15th, 2018
PRO Number
Pro00075735
Researcher
Nicole Pilch

Silhouette
Keywords
Heart, Kidney, Liver, Lung, Non-interventional, Transplant
Summary

A sample of patients will be drawn from a cross-sectional cohort of pre- and post-abdominal and cardiothoracic transplant recipients from March 2018 through May 2018. 10 to 15 minute key informant interviews will be conducted with patients to ascertain their views and perceptions related to adherence pre- and post-transplant and use of technolgy. This data will be used to educate the transplant community about adherence from the patient's perspective.

Institution
MUSC
Recruitment Contact
Nicole Pilch
843-792-3702
weimert@musc.edu

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

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

Silhouette
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
Akshay Shetty
404-941-6717
shetty@musc.edu

Validation of the Palliative Performance Scale to predict survival of older adults admitted to the hospital from the Emergency Department. Save

Date Added
August 4th, 2017
PRO Number
Pro00063739
Researcher
Leigh Vaughan

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Keywords
Cancer, Dementia, Heart, Kidney, Liver, Pulmonary, Stroke
Summary

The Palliative Performance Scale has been shown to predict survival among hospice and palliative medicine patients in the outpatient and inpatient clinical settings, where lower PPS scores are directly related to shorter survival. We seek to evaluate if this relationship persists among a racially diverse, older adult population when assessed at the time of admission from the emergency department.

Institution
MUSC
Recruitment Contact
Jonas Te Paske
8432597649
tepaske@musc.edu

A Multicenter, Randomized, Double-Blind, Placebo- Controlled Trial of Emricasan, an Oral Caspase Inhibitor, in Subjects with Decompensated Non-Alcoholic Steatohepatitis (NASH) Cirrhosis Save

Date Added
May 23rd, 2017
PRO Number
Pro00066592
Researcher
Don Rockey

Silhouette
Keywords
Liver
Summary

This is a treatment study for participants with Decompensated Non-Alcoholic Steatohepatitis (NASH) Cirrhosis to access whether the study drug emricasan compared to placebo improves event-free survival in subjects. Event free refers to subjects not experiencing any new compensation events and MELD score progression. The study treatment duration will be 48 weeks (1 year) with study visits every 4 weeks. Study drug will be provided at no cost to and participants will be compensated for their time and travel.

Institution
MUSC
Recruitment Contact
Mona Haj
843-876-2184
hajm@musc.edu

A Multi-Center, Randomized, Placebo-Controlled, Double-Blind Study to Confirm Efficacy and safety of Terlipressin in Subjects with Hepatorenal Syndrome Type 1 (The CONFIRM Study) Save

Date Added
May 23rd, 2017
PRO Number
Pro00066692
Researcher
Don Rockey

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Keywords
Kidney, Liver
Summary

The purpose of this study is to confirm the efficacy and safety of terlipressin in the treatment of adult subjects admitted to the hospital with hepatorenal syndrome (HRS) Type 1. Hepatorenal syndrome Type 1 is a severe, but potentially reversible, form of renal failure that afflicts patients with severe chronic liver disease associated with cirrhosis. This will be a randomized, placebo-controlled, and double-blinded multi-center study. Patients will be randomly be placed in either a terlipressin-treatment group or a placebo group. Neither you nor the study team will know which group you have been placed in. The study drug will be given as an IV injection every 6 hours while the patient is an inpatient at the hospital every 6 hours. This is a phase 3 study, with prior studies already showing promising results.

Institution
MUSC
Recruitment Contact
Mona Haj
8438760581
hajm@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

Silhouette
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 Phase 2 Double-blind, Randomized, Placebo-controlled, Dose-finding Study to Evaluate the Safety, Tolerability and Efficacy of Volixibat Potassium, an Apical Sodium-Dependent Bile Acid Transporter Inhibitor (ASBTi) in Adults with Nonalcoholic Steatohepatitis (NASH) Save

Date Added
January 10th, 2017
PRO Number
Pro00062437
Researcher
Don Rockey

Silhouette
Keywords
Liver
Summary

This is a treatment study for people who have Nonalcoholic Steatohepatitis (NASH) fibrosis but not cirrhosis. The purpose of the study is to see whether the oral investigational medication, Volixibat potassium, is effective and safe in treating liver fibrosis.

This study will be a Phase 2, 48-week, multicenter, double-blind, randomized, PBO-controlled, parallel group,
proof of concept, dose-finding study, with one IA after at least 80 subjects have received 24 weeks of treatment.
There will be 3 active arms of volixibat (5, 10 and 20 mg) and a PBO arm. Subjects will be randomized to
receive one of three doses of volixibat (5, 10, or 20 mg) once daily (QD) or PBO in a 1:1:1:1 ratio. Subjects
with fibrosis stages F0 through F3 may be enrolled, but the number of F0 subjects will be capped at 88 if 1 dose
is dropped after the IA and at 78 if 2 doses are dropped (approximately 30% of the total number of subjects).
Depending on the outcome of the IA, one or more treatment arms will be discontinued or the study may be
terminated. The follow-up period will be 4 weeks after last dose. Subjects will be expected to visit the study
center at least 10 times.

Institution
MUSC
Recruitment Contact
Brittiny Bowers
843-876-2184
wulfb@musc.edu

A randomized, double-blind, placebo-controlled pilot study to assess the safety and efficacy of ifetroban for the treatment of portal hypertension in cirrhotic patients Save

Date Added
January 10th, 2017
PRO Number
Pro00059389
Researcher
Don Rockey

Silhouette
Keywords
Drug Studies, Liver
Summary

This is a treatment study for people who have cirrhosis and portal hypertension. The purpose of the study is to see whether the investigational drug Ifetroban is safe and effective in reducing portal pressure and its effects. The study will last about 14 weeks and will require you to come to MUSC 4 times to receive the study treatment. Study drug will be provided at no cost to you and you will be compensated for your time and travel.

Institution
MUSC
Recruitment Contact
Brittiny Bowers
843-876-2184
liverstudies@musc.edu

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