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


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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

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

A Randomized, Double-blind, Placebo-controlled Study to Assess the Safety, Tolerability, and Pharmacodynamics of SYNB1020 in Hepatic Insufficiency and Cirrhosis Patients Save

Date Added
June 26th, 2018
PRO Number
Pro00077806
Researcher
Don Rockey

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Profiles_link
Keywords
Digestive System, Drug Studies, Liver
Summary

This is a clinical research study of an investigational new drug that is being developed as a possible treatment in patients with hepatic insufficiency, cirrhosis and or/elevated blood ammonia levels. Ammonia is a substance that is built during the breakdown of the proteins in blood; in case of errors in the breakdown of proteins, ammonia levels might increase. Elevated ammonia may lead to other medical conditions. The study will help to determine the safety and tolerability of the study medication in male and female patients; in addition, the study investigates the study medications pharmacokinetics and pharmacodynamics.
This study is an inpatient study.
This study consists of 2 parts (part 1 and part 2). However our institution will only be taking part in part 2 of the study (described below) because recruitment for part one has been closed (as indicated by our sponsors).
Patients will initially present for a screening visit where eligibility will be determined. If patients are eligible for this study they will be admitted to an inpatient unit for a total of 12 days. During the 12 days of hospital stay, patients will receive study drug/placebo, regulated diet (predetermined as per study protocol) and several blood tests will be withdrawn measuring serum ammonia levels during this hospital stay. Once patients are discharged from hospital stay, they will be expected to follow up 1 week and 70 days after last study drug/placebo was administered (i.e last day in the hospital) with a stool sample.

Institution
MUSC
Recruitment Contact
Roula Sasso
843-876-8439
liverstudies@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

List of Studies


Profiles_link
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

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
Melissa Youssef
8648843508
youssefm@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

List of Studies


Profiles_link
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

List of Studies


Profiles_link
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

List of Studies


Profiles_link
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

List of Studies


Profiles_link
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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