A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Safety and Efficacy of Selonsertib in Subjects with Nonalcoholic Steatohepatitis (NASH) and Bridging (F3) Fibrosis Save

Date Added
May 23rd, 2017
PRO Number
Pro00066711
Researcher
Don Rockey
Keywords
Disease Prevention, Drug Studies, Liver, Stage III, Weight Control
Summary

This is a phase 3, randomized, double-blind, placebo controlled study evaluating the safety and efficacy of an investigational drug called selonsertib in subjects with NASH and bridging (F3) fibrosis.
The primary goal of this study is to evaluate whether selonsertib (SEL) can cause fibrosis reversal and reduce progression to cirrhosis and associated complications in subjects with NASH and bridging (F3) fibrosis. The secondary goal of this study is to assess the safety and tolerability of SEL in subjects with NASH and bridging (F3) fibrosis. Subjects will be treated for 240 weeks, and participation in the study can last up to 260 weeks, which includes an 8-week screening period, a 240-week treatment period, and a 4-week follow-up period and a telephone follow-up at 12 weeks after the Week 240 Visit.

Institution
MUSC
Recruitment Contact
Brittiny Bowers
843-876-2184
wulfb@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 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 Phase 3, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Safety and Efficacy of Selonsertib in Subjects with Compensated Cirrhosis due to Nonalcoholic Steatohepatitis (NASH) Save

Date Added
May 23rd, 2017
PRO Number
Pro00066720
Researcher
Don Rockey
Keywords
Disease Prevention, Drug Studies, Liver, Stage III
Summary

This is a Phase 3, randomized, double-blind, placebo-controlled study
evaluating the safety and efficacy of a drug called selonsertib in subjects with compensated cirrhosis due to non-alcoholic steatohepatitis (NASH). The primary goal of this study is to evaluate whether selonsertib (SEL) can reverse the liver fibrosis seen in patients with NASH cirrhosis and reduce the potential complications associated with cirrhosis. A secondary goal of this study is to assess the safety and tolerability of the drug, selonsertib, in subjects with NASH cirrhosis. Participation in this study can last up to 260 weeks, which includes an 8-week screening period, a 240-week treatment period, and a 4-week follow-up period, and a telephone follow-up visit 12 weeks after the week 240 visit.

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
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

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
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.

Maximum duration of subject involvement in the study:
? Planned duration of screening period: 56 days
? Planned duration of enrollment period: 364 days
? Planned duration of treatment period: 336 days
? Planned duration of follow-up: 28 days

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

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

Date Added
December 13th, 2016
PRO Number
Pro00059473
Researcher
Don Rockey
Keywords
Liver
Summary

This study is involves an investigational drug called emricasan. The purpose of the study is to find out if the drug is safe and effective in treating portal hypertension in patients with NASH cirrhosis and portal hypertension. The study will last about 32 weeks and and involve 9 visits to the study doctor. Participants will receive all study-related treatment and care at no cost and will be compensated up to $500 for completing the study.

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

A Multicenter, Randomized, Double-Blind, Placebo-controlled Trial of Emricasan (IDN-6556), an Oral Caspase Inhibitor, in Subjects with Non-alcoholic Steatohepatitis (NASH) Fibrosis Save

Date Added
April 26th, 2016
PRO Number
Pro00053397
Researcher
Don Rockey
Keywords
Drug Studies, 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, Emicasan, is effective and safe in treating liver fibrosis. The study will last for one and a half years and require participants to come to MUSC at least 11 times. Participants will be compensated for their time and effort.

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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