Establishing the normal range of fasting venous ammonia level in healthy volunteers Save

Date Added
August 28th, 2018
PRO Number
Pro00078817
Researcher
Don Rockey

Silhouette
Keywords
Healthy Volunteer Studies
Summary

This study will involved 30 healthy individuals. Subjects cannot be currently taking any medications. A total of 4 blood tubes will be obtained after at least 4 hours of fasting state from these subjects and the venous ammonia results obtained from these subjects will be used to establish the normal range of ammonia for an upcoming phase 1b/2a study by the same sponsors.

This study will consist of only 1 clinic visit which will last around 30 - 45 minutes long. Bloods will be withdrawn as the South Carolina Translational Reseasrch (SCTR) outpatient clinics and the bloods will be analyzed at the Medical University of South Carolina laboratory.

Institution
MUSC
Recruitment Contact
Megan Bickford
8438768439
liverstudies@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

Silhouette
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 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

Silhouette
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

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

Silhouette
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

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 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

Silhouette
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

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, Elafibranor, is effective and safe in treating liver fibrosis.

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

Silhouette
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

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

Silhouette
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

Change_preferences

-- OR --

Create_login