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
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

A Phase 3, Double-Blind, Randomized, Placebo-Controlled, Multicenter Study to Evaluate the Efficacy and Safety of Obeticholic Acid in Subjects with Compensated Cirrhosis due to Nonalcoholic Steatohepatitis Save

Date Added
June 12th, 2018
PRO Number
Pro00077361
Researcher
Don Rockey
Keywords
Liver
Summary

The primary objectives of this study are to evaluate the effect of Obeticholic Acid treatment compared to placebo on 1) histological improvement and 2) liver-related clinical outcomes in patients with non-cirrhotic nonalcoholic steatohepatitis (NASH) with liver fibrosis.

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

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
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
Don Rockey
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

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
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
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 Multicenter, Randomized, Double Blind, Placebo-Controlled Phase III Study to Evaluate the Efficacy and Safety of Elafibranor in Patients with NonAlcoholic Steatohepatitis (NASH) and fibrosis (RESOLVE-IT) Save

Date Added
August 9th, 2016
PRO Number
Pro00056669
Researcher
Don Rockey
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, Elafibranor, is effective and safe in treating liver fibrosis.

Institution
MUSC
Recruitment Contact
Linsay Totin
843-876-8439
liverstudies@musc.edu

Comparison of 24-hours versus 72-hours of octreotide infusion along with endoscopic therapy in preventing early rebleed from esophageal varices: a multi-center, randomized clinical study Save

Date Added
July 16th, 2013
PRO Number
Pro00027015
Researcher
Don Rockey
Keywords
Digestive System, Esophagus, Liver, Vascular
Summary

The study will compare two durations of treatment with Octreotide in patients with confirmed esophageal variceal hemorrhage who have undergone successful endoscopy and possible endoscopic therapy for control of bleeding. All procedures including the treatment are the standard of care. Octreotide infusion and endoscopic therapy for esophageal variceal bleeding are not investigational.

Institution
MUSC
Recruitment Contact
Mary Hart
843-876-8439
hartmm@musc.edu

Assessment of Optimal Time to Repeat Endoscopy Following Primary or Secondary Prophylaxis of Esophageal Varices with Band Ligation: A Randomized, Prospective Trial Save

Date Added
July 16th, 2013
PRO Number
Pro00027001
Researcher
Don Rockey
Keywords
Circulation, Digestive System, Esophagus, Liver, Vascular
Summary

This study is to find the best time that a follow up appointment can be scheduled to benefit the patient with liver cirrohis to return after having the bleeding vessels in the esophagus repaired by directing a scope in the esophagus and using bands to stop the bleeding.

Institution
MUSC
Recruitment Contact
Yusuf Shami
843-876-8439
shami@musc.edu

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